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NasoAlveolar Molding
Treatment Protocol in
patients with Cleft Lip
and Palate
By Dr. Kritika Suroliya
Learning Objectives
• What is Pre-surgical Infant Orthopaedics?
• What is NasoAlveolar Molding?
• Fabrication of the appliance used for NasoAlveolar
Molding?
Contents:
• Introduction to CL/P
• Prevalence of CL/P
• Classification of CL/P
• Anatomy and characteristics of CL/P
• Problems Associated with CL/P in
children
• Pre-Surgical Infant Orthopaedics
• History
• Principle
• Advantages
• Disadvantages
• The NAM Appliance
 Principle
 Impression Technique
 Appliance Fabrication and Design
 Appliance Insertion and Taping
 Appliance adjustments
 Proponents and Opponents of NAM
• The Pre-Directional Appliance
• Conclusion
Introduction
• Facial Clefting is the second most common congenital
deformity.
• Orofacial Clefts, particularly non-syndromic cleft lip (CL),
with or without cleft palate (CLP), and isolated Cleft
Palate are the most common craniofacial deformities
affecting one in every 700 to 1000 newborns worldwide.
• Due to their disturbing appearance in many cases, these
deformities have attracted much attention in terms of
treatment and research.
Murray, J.C., 2002. Gene/environment causes of cleft lip
and/or palate. Clinical genetics, 61(4), pp.248-256.
Introduction
• Cleft lip and palate is one of the common facial deformities
that not only affect the aesthetics but also affect the speech
and hearing.
• Over the years various treatment modalities have been
attempted in these patients so as to achieve satisfactory
outcome.
• Surgical treatment of cleft lip and palate has been documented
since 317AD, when Chinese General Wei Yang Chi had his
cleft lip corrected by cutting and stitching the edges together.
• Since then various authors described the different surgical
techniques for correction of cleft lip.
Murthy P S, Deshmukh S, Bhagyalakshmi A, Srilatha K T. Pre Surgical Nasoalveolar Molding: Changing
Paradigms in Early Cleft Lip and Palate Rehabilitation. J Int Oral Health 2013; 5(2):76-86.
Introduction
• To further improve the esthetic result of surgical lip
repair, the concept of presurgical infant orthopedics was
developed.
• Presurgical infant orthopedics plays a significant role in
neonatal cleft lip and palate treatment.
Murthy P S, Deshmukh S, Bhagyalakshmi A, Srilatha K T. Pre Surgical Nasoalveolar Molding: Changing
Paradigms in Early Cleft Lip and Palate Rehabilitation. J Int Oral Health 2013; 5(2):76-86.
Prevalence
Prevalence
• The prevalence for non-syndromic CLP and CP in the
Nagpur region was found to be 0.66 percent and 0.27
percent, respectively.
• Most of the worldwide studies showed male
predominance for CLP and CP. In the present study,
however, females outnumbered males.
Kalaskar, R., Kalaskar, A., Naqvi, F.S., Tawani, G.S. and Walke, D.R., 2013. Prevalence and
evaluation of environmental risk factors associated with cleft lip and palate in a central Indian
population. Pediatric dentistry, 35(3), pp.279-283.
Classification
Classification
Cleft lip with or without clefting of the alveolar process (cleft of the
primary palate) (CL):
• The alveolar ridge is intact
• The cleft involves the height of the lip to some degree.
• The cleft lip may be unilateral or bilateral.
Classification
Isolated Cleft Palate (CP):
• Both the soft palate and hard palate are divided.
• A complete palatal cleft is classified as unilateral if the vomer is
attached to one of the palatal shelves.
• When the vomer is totally separated from the palatal shelves, its
lower free border can be detected between them, the cleft is then
classified as bilateral, although it remains median.
Classification
Combined cleft lip and palate (UCLP and BCLP):
• Subjects with combined cleft lip and palate have clefts in both
primary and secondary palate.
• The cleft formation may be complete, or incomplete; unilateral or
bilateral.
• Although the palatal cleft is always median, rotation of the vomer
may cause it to appear lateral.
David and Ritchie Classification (1922)
• Group 1: Pre-alveolar clefts (unilateral, bilateral and median)
• Group 2: Post alveolar clefts
• Group 3:Complete alveolar clefts (unilateral, bilateral and median)
Textbook of Oral and Maxillofacial Surgery – Neelima Anil Malik (3rd edition)
Veau (1931)
• Group 1: Cleft of the soft palate only
• Group 2: Cleft of the hard and the soft palate
• Group 3: Complete unilateral cleft, extending from uvula to incisive
foramen and then deviates to one side extending through the
alveolus
• Group 4: Complete bilateral alveolar cleft
Textbook of Oral and Maxillofacial Surgery – Neelima Anil Malik (3rd edition)
Fogh-Andersen (1942)
• Fogh-Andersen (1942) divided oral clefts into 3 main groups:
1) CL including clefts of the lip and alveolus
2) CL and CP including unilateral and bilateral cleft lip and palate.
3) CP being median and not extending beyond the incisive foramen.
Textbook of Oral and Maxillofacial Surgery – Neelima Anil Malik (3rd edition)
Kernahan and Stark (1958)
Textbook of Oral and Maxillofacial Surgery – Neelima Anil Malik (3rd edition)
Internationally Approved Classification
(1967), following Rome Congress
Textbook of Oral and Maxillofacial Surgery – Neelima Anil Malik (3rd edition)
Jensen et al (1988)
• Jensen et al (1988) divided the cleft palate into 4 grades to describe
the extent of the cleft palate into 4 grades:
1) Grade 1: soft palate
2) Grade 2: one-third of hard palate
3) Grade 3: More than one-third of hard palate
4) Grade 4: Total
Textbook of Oral and Maxillofacial Surgery – Neelima Anil Malik (3rd edition)
A new Classification system by Daigavane et al (2015)
Type A: Greater and Lesser segment are of
sufficient length
Type B: Greater alveolar segment is of
sufficient length but lesser alveolar
segment is small and/or placed posteriorly
Type C: Greater and lesser segments are of
small length or parallel to each other
Type D: Greater segment is overlapping the
lesser alveolar segment
(Daigavane P S, Hazarey PV, Niranjane P, Vasudevan SD, Thombare BR, Daigavane S. A New Classification System for Unilateral Cleft Lip
and Palate Infants to assist Presurgical Infant Orthopedics. The Journal of Clinical Pediatric Dentistry . Volume 39, Number 3/2015)
Anatomy and
Characteristics of
UCLP, CP and BCLP
Unilateral Cleft Lip and Palate
• The lip, nose and alveolus have a cleft at the right or the
left side.
• The cleft then continues into the palatal part of the
maxilla and separates the palatal bone at the level of the
nasal septum.
• The alveolar arch and palate are separated into a large
and a small segment.
• The segments are often laterally displaced and the
anterior end of the larger segments protrudes, and there
is a midline shift to the non-cleft side.
• The smaller segment is usually located dorsally and the
anterior part is slightly curved upwards, compared to the
larger segment.
Unilateral Cleft Lip and Palate
• Severe deviation of the noncleft side of the maxilla away
from the cleft, carrying with it the nasal structures
including the nasal septum.
• This distortion is the response of inadequately supported
bone structures to pressure.
Unilateral Cleft Lip and Palate
• Abnormal insertion of the cheek muscles on the maxilla
at the base of the nose causes a rotating force on the
larger segment during muscle contraction.
• This action is reinforced by tongue protrusion.
• The smaller segment on the cleft side is exposed to less
expanding force,& has a mild contracting force exerted by
the base of the nasal ala on this side.
Unilateral Cleft Lip and Palate
• Wide nostril base
• Separated lip segments
• Increased alar rim
• Oblique columella
• Overhanging nostril apex
• Nose is deviated toward normal side
• Except for alar base on cleft side, nostril is stretched and
straightened
• The affected lower lateral nasal cartilage is displaced laterally
and inferiorly, which results in a depressed dome
Murthy P S, Deshmukh S, Bhagyalakshmi A, Srilatha K T. Pre Surgical Nasoalveolar Molding: Changing
Paradigms in Early Cleft Lip and Palate Rehabilitation. J Int Oral Health 2013; 5(2):76-86.
Bilateral Cleft Lip and Palate
• The lower lateral cartilages fail to migrate up into the nasal tip to
stretch the columella.
• The prolabium also lacks muscle tissue and is positioned directly on
the end of the shortened columella.
• The alar cartilages are positioned along the alar margins and are
stretched over the cleft in a flared fashion.
• In a complete BCLP, the premaxilla is suspended from the tip of the
nasal septum, whereas the lateral alveolar segments remain behind.
Bilateral Cleft Lip and Palate
• Underdeveloped contralateral philtral ridge
• Ill-defined Cupid's bow, thin vermilion-mucosa on both sides of the
cleft.
• Protruding prolabium, demonstrates total absence of orbicularis oris
and seems to be joined directly to the tip of the nose.
Bilateral Cleft Lip and Palate
• The premaxilla relatively unsupported on nasal septum, is not able
to resist force of active tongue and tilts forward.
• If tongue habitually protrudes through one side, then premaxilla is
protruded and forced to opposite side, giving the asymmetry.
• The premaxilla is unrestrained by attachment to either segment of
the maxilla & is projected forward by the growth of the cartilagenous
septum.
Isolated Cleft Palate (CP)
• In isolated cleft palate, the extent of the cleft varies.
• The cleft can be submucous characterised by a bifid uvula, a notch in
the posterior hard palate and a muscular sling that is not united.
• The cleft can extend only into the soft palate or extend with varying
degrees into the hard palate.
• In complete cases, the cleft extends all the way to the incisive
foramen.
Simonart’s bands
• In some patients, lip clefting is not complete, but a soft tissue bridge is
located either at the base of the nostril or between the segmented alveolar
ridges.
• The soft tissue bridges are known as Simonart’s bands and can be present in
either unilateral or bilateral clefts.
Problems Associated
with Children born
with Cleft
•Nostril Defect: From mild Nose
Asymmetry to gross defect of nasal
cartilage and septum
•Short columella, hypoplastic maxilla,
short premaxilla and prolabium
Aesthetics
• In Pierre Robin Syndrome, along with cleft
palate, there is mandibular micrognathia
and glossoptosis. The underdeveloped
mandible results in tongue fall in the
oropharynx, airway obstruction of the child.
Airway
Obstruction
•Structural defects prevent negative
oral pressure for effective sucking.
•Normal Palate function is necessary
for deglutition
Feeding
Textbook of Oral and Maxillofacial Surgery – Neelima Anil Malik (3rd edition)
Dental
Problems
Impaired
Speech
Auditory
Problems
• Congenitally absent/supernumerary teeth
• Crowding/ displacement of teeth
• Morphologically deformed/ hypomineralised
teeth
• Impaired velopharyngeal mechanism leading to
hypernasal speech.
• Retardation of consonant sounds (p,b,t,d,k and
g)
• The levator and tensor muscles of the soft palate
affect the opening of the auditory tube, increasing
susceptibility to middle ear infections.
• Additional hazard of lymphoid hyperplasia over the
auditory tube orifice in the nasopharynx
Textbook of Oral and Maxillofacial Surgery – Neelima Anil Malik (3rd edition)
Role of an orthodontist?
• The craniofacial orthodontist is involved in the life of a patient born with a
craniofacial deformity and/or cleft lip and palate from birth through skeletal
maturity.
• This may include infant presurgical orthopedics, early mixed dentition treatment,
dentofacial orthopedics and orthodontics, preparation for alveolar bone graft
procedures, adolescent/adult orthodontics, preprosthetic orthodontics, and pre- and
postsurgical orthodontics.
Santiago, P.E. and Grayson, B.H., 2009, December. Role of the craniofacial orthodontist on the craniofacial
and cleft lip and palate team. In Seminars in Orthodontics (Vol. 15, No. 4, pp. 225-243). Elsevier.
Treatment Protocol associated with
treatment of cleft children
2-4 weeks: Lip
Closure (Infant
Orthopaedics)
12-18 months:
Palate Closure
7-8 years: Alignment
of maxillary incisors
7-9 years: Alveolar
bone graft (before
eruption of lateral
incisor, if present, or
canine)
Adolescence:
Comprehensive
Orthodontics,
Lip/nose revision?
Late Adolescence:
Orthognathic
Surgery
Contemporary Orthodontics: William R. Profitt (5th edition)
Eurocleft Protocol
• Clefts of the lip, alveolus and/or palate affect between 1 per 500 to 1 per 700
live births in Europe (World Health Organization, 1998).
• Approaches to cleft care in Europe vary considerably between countries.
Within the Nordic countries there is a tradition of centralization of services.
Other countries such as France, Germany and Italy (and until recently, the
UK) provide cleft care via large numbers of local services who may see but a
few patients with clefts.
A Six-Center International Study Of
Treatment Outcome in Patients with
Clefts of Lip and Palate
•Part 1: Principles and Study Design
•Part 2 : Craniofacial form and soft tissue profile.
•Part 3 : Dental Arch Relationships
•Part 4 : Assessment of nasolabial apperance
•Part 5 : General discussion and conclusion
Shaw, W.C., Dahl, E., Asher-Mcdade, C., Brattström, V., Mars, M., Mcwilliam, J., Mølsted, K., Plint, D.A., Prahl-Andersen, B., Roberts, C. and Semb, G.,
1992. A six-center international study of treatment outcome in patients with clefts of the lip and palate: Part 5. General discussion and conclusions. The
Cleft palate-craniofacial journal, 29(5), pp.413-418.
Americleft Protocol
• In 2006, the Executive Council of ACPA approved funds for the Research
Education Committee to organize a pilot project which has become
“Americleft”, an ACPA Task Force.
• Six centers were identified to participate in the pilot project which resulted
in 3 face-to-face meetings over the past two years, completion of initial
comparisons of dental arch relationship outcomes, cephalometric
morphology outcomes, nasolabial esthetic outcomes and the protocol for
assessing speech outcomes.
• The results of these have all confirmed the value and benefits of well-
controlled and well-designed inter-center outcome comparisons.
Americleft study guide
Sawangi Protocol for Treatment of Cleft Lip and Cleft Palate
Birth:
Initial
Assessment
Pre-surgical
assessment
(PNAM)
8-9 year:
Initial
Interventional
Orthodontics
Preparation of
Alveolar Bone
Grafting
3 Month:
Primary
Lip repair
10 years:
Alveolar
Bone Graft
9-18
Month:
Palate
Repair
12-14years:
Definite
Orthodonti
cs
2 year:
Speech
Assessment
16 years:
Nasal
Revision
Surgery
3-5 year:
Lip
Revision
Surgery
17-20
years:
Orthognath
ic Surgery
Infant Orthopaedics
• In children, with severe distortion of the maxillary arches, surgical closure
of the lip which is carried out in the early weeks of life, can be extremely
difficult.
• Orthodontic intervention to reposition the segments and to bring protruding
premaxillary segment back into the arch may be needed to obtain a good
surgical repair of the lip.
• This “infant orthopaedics” is one of the few instances in which orthodontic
treatment for a newborn infant, before the eruption of any teeth, may be
indicated.
Contemporary Orthodontics: William R. Profitt (5th edition)
Pre-Surgical Infant
Orthopaedics
Definition
• PSIO is defined as any orthopedic manipulation of the segments of the
clefted maxilla in a newborn with complete unilateral or bilateral CLP
aiming at establishing a more normal maxillary alveolar arch form or at
retracting a protruding premaxilla to facilitate the surgical repair of
lip.(Glossary of Orthodontic terms, 2000)
Pre-Surgical Infant Orthopaedics
• Presurgical Infant Orthopaedics has been used in the treatment of cleft lip
and palate patients for centuries.
• Early techniques focused on elastic retraction of the protruding premaxilla
followed by stabilization after surgical repair.
Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with
cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
Pre-Surgical Infant Orthopaedics (PSIO)
• This concept was introduced at University of Glasgow by Kerr McNeil in
1954 as an adjunctive neonatal therapy aiming at nonsurgical reduction of
the size of the alveolar cleft.
• The rationale behind “Maxillary Orthopedics” as described by McNeil,
Burston and Rosenstein is that early segment alignment will allow the
maxillary halves to develop normally even though a normal bony union is
not present.
• The primary purpose of the appliance prior to lip closure is not to proliferate
tissue or initiate growth but to guide the maxillary segments into proper
spatial position with each other and with the mandibular arch.
Singla, S. and Kaur, M., 2008. Cleft palate habilitation. The Indian Journal of Pediatrics, 75(7), pp.703-708.
Advantages of PSIO
Surgical benefits:
• Allows a surgical cleft closure without tension and mobilization of the surrounding soft tissue.
• In complete unilateral clefts of primary and secondary palate, the defective oropharyngeal
musculature allows unrestricted lateral and superior rotation of the maxillary segments in a
medial and inferior direction and recontour the greater segment, restoring a normal premaxillary-
maxillary arch relationship and thus facilitating surgical repair of cleft lip.
• In case of bilateral clefts, the premaxilla is rotated superiorly and anteriorly and the maxillary
segments are retruded and rotated medially and superiorly. Repair of lip without first
repositioning the segments of the maxilla would lock the premaxilla outside the maxillary
segments in a forward position. This allows the lower lip to fall behind the premaxilla, retruding
the mandible, allowing overdevelopment of the premaxillary alveolar area and creating an
excessive overbite.
Singla, S. and Kaur, M., 2008. Cleft palate habilitation. The Indian Journal of Pediatrics, 75(7), pp.703-708.
Advantages of PSIO
• An Orthopaedic feeding appliance facilitates the correction by expanding the
maxillary buccal segments and retruding the premaxilla with or without
external strappings.
• The constant gentle pressure of the appliance against the palatal tissues
serves as a stimulus for the growth of underlying bone. This results in a
narrowing of the palatal cleft and greatly benefits surgical repair.
• Another advantage is reduction in width of the cleft in the alveolar process
which means that there is more chance of the segments forming a butt joint
in the alveolar process region and possibility of an over contracted upper
arch after lip repair is therefore, reduced.
Singla, S. and Kaur, M., 2008. Cleft palate habilitation. The Indian Journal of Pediatrics, 75(7), pp.703-708.
Advantages of PSIO
Aid to plastic surgeon:
• The orthopedic repositioning of the premaxillary region of the greater
segment, and the repositioning of the premaxilla restore the skeletal base
under the nose and lip to a more normal position and permit a more
aesthetic reconstuction of the cleft lip. The better the original correction of
the lip, the less likelihood there is of secondary surgical correction
Singla, S. and Kaur, M., 2008. Cleft palate habilitation. The Indian Journal of Pediatrics, 75(7), pp.703-708.
History
1) Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in
patients with cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
3) Esenlik E. Presurgical Infant Orthopedics for Cleft Lip and Palate: A Review. Journal of Surgery
[Jurnalul de chirurgie] 2015; 11(1): 9-14. doi:10.7438/1584-9341-11-1-2
2) Bilgic F, Sozer OA. Diagnosis and presurgical orthopedics in infants with cleft lip and palate. Eur J
Gen Dent 2015;4:41-7
History
• 1689- Hoffman demonstrated the use of facial binding to narrow the cleft
and reduce post surgical dehiscence.
• 1790- Similar technique was shown by Desault
• 1844- Hullihen stressed the importance of presurgical preparation of clefts
using an adhesive tape binding.
• 1844- Esmarch and Kowalzig used a bonnet and strapping to stabilize the
premaxilla after surgical retraction.
• 1927- Brophy demonstrated the passing of a silver wire through both the
ends of the cleft alveolus, and then progressively tightened the wire
Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with
cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
McNeil Method (1950)
• The modern school of cleft lip and palate was started by McNeil.
• McNeil was the first in aligning presurgically the alveolar parts in
cleft lip and palate patients.
• He suggested the use of serial appliances to approximate cleft
alveolar segments.
• By molding the palatal segments into the correct position using a
series of acrylic plates, McNeil believed that this would produce a
normal maxilla, while reducing the alveolar and palatal cleft at the
same time.
• McNeil and Burston claimed that soft tissues overlying the hard
palate were stimulated to grow, and they also added that neonatal
maxillary orthopedics could control and modify the postnatal
development of the maxilla.
Latham Device (1975)
• Georgiade and Latham introduced a pin retained
active appliance to simultaneously retract the
premaxilla and expand the posterior segments,
which is followed by alveoloperiosteoplasty and
lip adhesion.
• According to Drs. Latham and Millard, these
alignments allow the performance of
gingivoperiosteoplasty (GPP), providing
stabilization of the maxillary segments and
reconstruction of the nasal floor.
• Also known as the dentomaxillary advancement
(DMA) appliance
Latham Device (1975)
• The appliance is surgically placed anywhere from 2 to 5 months of age.
• The Latham appliance works by simultaneously applying pressure to the
cleft segments over a 4 to 6 week period to move the alveolar segments into
proper position.
• However, an anterior as well as a posterior cross-bite is an unwarranted side
effect that may occur more frequently
Latham Device (1975)
• Bercowitz et al. reported a longitudinal study in unilateral and
bilateral cleft lip and palate treated with the Latham device. They
also performed periosteoplasty in all cases, and compared the results
to patients treated with a non-orthopedics procedure without GPP,
and treated just with a lip adhesion method. They found a higher
frequency of anterior and posterior crossbite in the presurgical
orthopedics group.
• Dr. Latham applied the Latham device with less extensive surgery in
cases of bilateral cleft lip and palate, and he assessed their dental
occlusion and lateral head radiographs at 5 years of age. He found
greater values for cephalometric measures in maxillary length,
maxillary prominence, and ANB angle compared to previous cases
Hotz Appliance (1987)
• Hotz et al. described the use of a passive orthopaedic plate to slowly
align the cleft segments.
• Also known as the Zurich approach.
• Arch alignment is achieved by grinding away the acrylic in specific
areas.
• According to Hotz and Gnoinski, the primary aim of presurgical
orthopedics is not to facilitate surgery or to stimulate growth, as
postulated by McNeil, but to take advantage of intrinsic
developmental potentials.
Hotz Appliance (1987)
• There are studies that have shown that this appliance has failed to prevent
collapse of the alveolar segments
Hotz Appliance (1987)
• Therefore, the Zurich approach, after a lip operation is
performed at the age of 6 months, palate repair is
postponed until 5 years of age.
• In a long term study, Silvera et al. concluded that The
two-stage palatoplasty in combination with application of
the Hotz plate had good effects on the maxillary growth
than one stage palatoplasty without Hotz plate up to the
age of 12 years.
Grayson’s Technique (1993)
• Grayson et al. described a new technique to pre surgically mold the alveolus,
lip and nose, in infants born with cleft lip and palate.
• PNAM has become very popular among orthodontists because of its nasal
molding effect.
• It is also suggested to correct septal deviation in early ages without surgery.
Grayson’s Technique (1993)
• Grayson pointed out that multiple nasal surgical revisions are often indicated
to approximate the nasal symmetry, because surgical techniques for
managing nasal deformity are lacking.
• He also pointed out that in bilateral cleft lip and palate (BCLP), the deficient
columella and ectopic premaxilla are the primary reconstructive challenges.
Multiple nasal surgeries are required, which often result in excessive
scarring at the columella-prolabial junction, and lack of nasal projection.
• Therefore, he emphasized the importance of nasal molding before surgery in
the early neonatal period.
DynaCleft and Nasal Elevators
• DynaCleft® is a premade nasal and alveolar molding device which can be
used to successfully mold the upper lip, alveolus and nose prior to cleft lip
repair.
• Unlike tape, DynaCleft offers the benefit of being able to provide a constant
approximation force with an elastic center that allows it to conform to a
baby’s mouth better because of its ability to expand and contract.
• Additionally, the controlled force that it provides to the prolabium and
premaxilla could improve surgical results and decrease the necessity of early
lip adhesion surgery
Vinson, L.A., 2016. Presurgical orthopedics in cleft lip and
palate care. Open J Dent and Oral Med, 4, pp.14-19.
Vinson, L.A., 2016. Presurgical orthopedics in cleft lip and
palate care. Open J Dent and Oral Med, 4, pp.14-19.
Classification of PSIO Appliances
Huener&Liu(1993)
Active or Passive
Pre-Surgical and Post-
Surgical
Intra-Oral or Extra-oral
Murthy P S, Deshmukh S, Bhagyalakshmi A, Srilatha K T. Pre Surgical Nasoalveolar Molding: Changing
Paradigms in Early Cleft Lip and Palate Rehabilitation. J Int Oral Health 2013; 5(2):76-86.
EuropeanCleft
Association-ECA(1999)
Active
Semi-Active
Passive
Active Appliances
Active appliances mold the separate alveolar processes into position by
applying active forces on them or, in other words, by directing them to
grow or to be moved into a preplanned position.
Figure 5
Active appliance, designed to expand and to move the lesser alveolar segment laterally.
Notes: (A) The two alveolar segments are not aligned as shown by the red doted lines. (B) An acrylic
appliance was placed (red shaded area) and as a result of molding the greater alveolar segment was moved
towards the lesser one while the lesser segment was moved laterally by expansion to allow this. The green
arrows show the direction of movement of both segments. The greater segment may then be retracted and
molded into a more natural position.
Alzain, I., Batwa, W., Cash, A. and Murshid, Z.A., 2017. Presurgical cleft lip and palate
orthopedics: an overview. Clinical, cosmetic and investigational dentistry, 9, p.53.
Passive Appliances
Figure 6
Passive appliance.
Notes: No need to move the smaller alveolar segment laterally; there is enough space for larger segment to
mold. (A) The two alveolar segments are not aligned as shown by the red doted lines. (B) An acrylic
appliance was placed (shaded area) and as a result of molding the greater alveolar segment was moved
towards the lesser one. The green arrow shows the direction of movement of the segments. Note that the
lesser segment did not move. (C) The two segments after alignment.
Alzain, I., Batwa, W., Cash, A. and Murshid, Z.A., 2017. Presurgical cleft lip and palate
orthopedics: an overview. Clinical, cosmetic and investigational dentistry, 9, p.53.
Lip Strap/Lip Taping
• A combination of intra-oral appliances
and/or extra-oral orthopedic strapping
can be used in preparation for
primary lip and plate surgery. In
combination with the intraoral mouth
plates, external tapes and elastics
may be strapped to the cheeks to
provide some external forces in the
alveolar molding process.
• Elastic forces will exert a retracting,
backward pressure against the
protruding premaxilla, and careful
use of forces on the cleft segments will
improve their positions and allow
definitive lip skin and muscle repair
Alzain, I., Batwa, W., Cash, A. and Murshid, Z.A., 2017. Presurgical cleft lip and palate
orthopedics: an overview. Clinical, cosmetic and investigational dentistry, 9, p.53.
Alzain, I., Batwa, W., Cash, A. and Murshid, Z.A., 2017. Presurgical cleft lip and palate
orthopedics: an overview. Clinical, cosmetic and investigational dentistry, 9, p.53.
Pre-Surgical
NasoAlveolar
Molding (PNAM)
• The PNAM treatment protocol for cleft patients has been described by
Grayson et al (1993)
Brecht et al (1995)
Grayson and Santiago (1997)
And Cutting et al (1998)
Presurgical nasoalveolar molding; Grayson et al.,
Cleft palate craniofacial journal, November 1999, vol 36, No. 6
Principle
High levels of hyaluronic acid, a component of
proteoglycan intracellular matrix, found
circulating in infants several weeks after birth
Temporary plasticity of the nasal cartilage
increases
Favourable for active molding and
repositioning of the nasal cartilages.
Grayson, B.H. and Cutting, C.B., 2001. Presurgical nasoalveolar orthopedic molding in primary correction of
the nose, lip, and alveolus of infants born with unilateral and bilateral clefts. The Cleft palate-craniofacial
journal, 38(3), pp.193-198.
Matsuo’s Concept
Auricular cartilage could
be molded with
permanent results if
treatment was started
within 6 weeks of life
During this period there
are high levels of
maternal estrogen in the
fetal circulation
Which triggers an
increase in the
hyaluronic acid
Hyaluronic acid alters
the cartilage, ligament
and connective tissue
elasticity by breaking
down intercellular
matrix.
Levels of estrogen start
dropping at 6 weeks of
age.
Murthy P S, Deshmukh S, Bhagyalakshmi A, Srilatha K T. Pre Surgical Nasoalveolar Molding: Changing
Paradigms in Early Cleft Lip and Palate Rehabilitation. J Int Oral Health 2013; 5(2):76-86.
Objectives of PNAM
• Active molding and repositioning of the deformed nasal cartilages and alveolar processes.
• Lengthening of the columella and correcting the position of the philtrum.
• Placement of the lip segments in a more anatomically correct position facilitating lip repair without
scarring.
• Forces exerted on nasal structures while performing alveolar molding permit straightening of
columella and correction of alar cartilage displacement. Thereby reducing the number of nasal
surgical procedures and improving nasal esthetics.
• It has also been suggested by Pritchard (1946) that bone healing was inversely proportional to the
size of cleft viz larger the cleft slower is the bone healing. Hence presurgical naso alveolar molding is
recommended to produce more favorable bone formation by reducing the size of the cleft.
• Reduces the need for secondary alveolar bone grafts.
Murthy P S, Deshmukh S, Bhagyalakshmi A, Srilatha K T. Pre Surgical Nasoalveolar Molding: Changing
Paradigms in Early Cleft Lip and Palate Rehabilitation. J Int Oral Health 2013; 5(2):76-86.
Advantages
• Improvement in arch form
• Facilitation of surgical closure
• Improvement of aesthetic outcome
• Facilitation of feeding
• Improvement of speech
• Elimination of surgical columella reconstruction and the resultant scar
tissue in bilateral cleft lip and palate.
Niranjane, P.P., Kamble, R.H., Diagavane, S.P., Shrivastav, S.S., Batra, P., Vasudevan, S.D. and Patil, P., 2014. Current
status of presurgical infant orthopaedic treatment for cleft lip and palate patients: A critical review. Indian Journal of
Plastic Surgery: Official Publication of the Association of Plastic Surgeons of India, 47(3), p.293.
Disadvantages
• PSIO approaches are complex and expensive and might have an adverse
effect on maxillary growth.
• Constricted upper maxilla in all 3 dimensions
• Development of Crossbites
• Uncontrolled mandibular growth if unnoticed
• Overlapping of the two segments
• Complete closure of the defect with alveolar molding does not allow the
surgeon to create perfect nasal floor.
Niranjane, P.P., Kamble, R.H., Diagavane, S.P., Shrivastav, S.S., Batra, P., Vasudevan, S.D. and Patil, P., 2014.
Current status of presurgical infant orthopaedic treatment for cleft lip and palate patients: A critical review. Indian
Journal of Plastic Surgery: Official Publication of the Association of Plastic Surgeons of India, 47(3), p.293.
Concept of Gingivoperioplasty
• The surgical bridging of the cleft alveolar process with periosteal flap was
initially described by Skoog (1965) as a means of stabilizing the separated
segments of the maxilla.
• Skoog’s technique necessitated wide mucoperiosteal dissection to mobilize
the flaps enough to allow for approximation of cleft alveolus as he did not
perform pre surgical nasoalveolar molding.
• Current technique of gingivoperioplasty introduced by Millard and Latham
(1990) is performed after the patients undergo presurgical orthopedic closure
of the cleft alveolar gap.
Murthy P S, Deshmukh S, Bhagyalakshmi A, Srilatha K T. Pre Surgical Nasoalveolar Molding: Changing
Paradigms in Early Cleft Lip and Palate Rehabilitation. J Int Oral Health 2013; 5(2):76-86.
Concept of Nasal Molding
• According to Millard (1984) clefting is due to disturbance of embryogenesis
and proper closure of all involved structures should be achieved as soon as
possible to favor normal growth of the face.
• Matsuo et al designed a nasal stent for the correction of the nasal
deformity.
• Another modification as suggested by Grayson was addition of nasal stent in
the alveolar molding plate.
• Modified extra oral nasal molding appliance was suggested by Doruk C et al
(2005).
Murthy P S, Deshmukh S, Bhagyalakshmi A, Srilatha K T. Pre Surgical Nasoalveolar Molding: Changing
Paradigms in Early Cleft Lip and Palate Rehabilitation. J Int Oral Health 2013; 5(2):76-86.
Criteria for
Naso
Alveolar
Molding
(NAM)
Infants must present
for treatment
between 2-4 weeks of
age
NAM is limited to
most severe cases
and treatment MUST
be performed on-site.
As per guidelines of Smile Train
Candidates for NAM
• Infants presenting with extremely wide unilateral clefts and severe nasal
deformity.
• Infants presenting with bilateral clefts with moderate to severe pre-
maxillary protrusion.
• Parents should be aware that NAM involves 7-10 follow up visits over a
period of approximately 3 months
• Committed and motivated parents of infants living far from the treatment
facility and unable to return for the required follow-up visits, should be
offered facial taping with or without a nasal stent as a treatment option
• Information on nutritional/oral hygiene as it pertains to the future dental
health of the infant should be provided to parents (post NAM, facial taping).
As per guidelines of Smile Train
Cases without the need for NAM?
• If there is no cleft at hard palate and cleft is a secondary cleft palate
involving soft tissues and uvula or if there is no nasal deformity with a cleft
forming an alveolar notch without a condition that make nutrition of infant
challenging, no preoperative orthodontic treatment is needed.
• However, a nutrition plate will be appropriate if there is an isolated cleft
palate that makes nutrition of infant challenging.
Bilgic F, Sozer OA. Diagnosis and presurgical orthopedics in infants with cleft lip and palate. Eur J Gen Dent
2015;4:41-7
NasoAlveolar Molding Appliance
• The NasoAlveolar Molding (NAM) Appliance consists of an intraoral molding
plate and nasal stents to mold the alveolar ridge and nasal cartilage
concurrently.
• NAM has been shown to significantly improve the surgical outcome of
primary repair in cleft lip and palate patients compared to other techniques
of presurgical orthopaedics.
Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with
cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
Impression Technique
• Initial impression of the infant with cleft lip and palate is obtained within
the first week of birth.
• Heavy bodied silicone impression material is used to take the initial
impression.
• The impression is best taken in a clinical setting that is prepared to handle
airway emergency, if at all encountered.
• A surgeon is always present during the impression process.
Grayson’s Technique
• The infant is held upside down and the impression tray is inserted into
the oral cavity.
• The infant is held in an inverted position to prevent the tongue from
falling back and to allow fluids to drain out of the oral cavity.
• The tray is seated until the impression material reaches the posterior
border of the impression tray, but not beyond.
• The impression must adequately cover the anatomy of the upper gum
pads and palatal shelves and include the vestibular folds.
Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with
cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
• Infant experiences Pressure on chest and torso.
• An extra person was required to hold the child.
Other Methods
• Prashanth Mishra et al, obtained impression when the infant was awake in a prone
position.
• Dubey et al made impression of upper arch using ice cream stick and impression
compound.
Appliance Fabrication and Design
• The molding plate is fabricated on the dental stone model.
• The plate is made of self-cure acrylic resin.
• The plate must be 2–3 mm in thickness to provide structural integrity and to
permit adjustments during the process of molding.
• A retention button is fabricated and positioned anteriorly at an angle of
approximately 40˚ to the plate. This angle is adjusted or optimized to
achieve maximum stability on the alveolar ridges.
Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with
cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
Appliance Fabrication and Design
• For the appliance employed in the treatment of a unilateral cleft, only one
retention arm is used.
• The vertical position of the retention arm should be at the junction of the
upper and lower lip.
• Orthodontic elastics and tapes attached to the retention button secures the
molding plate in the mouth, resting on the alveolar ridges and palatal
shelves.
• A small opening measuring 6–8 mm in diameter is made on the palatal
surface of the molding plate to provide an airway in the event that the plate
drops down posteriorly.
Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with
cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
Concept of Alveolar Molding
• The appliance is selectively grinded in the areas were movement is expected
at the same time soft denture liner is added in the region which require
molding.
• The soft denture liner applies pressure on the alveolar ridge.
Appliance Insertion and Taping
• The appliance is then secured extraorally to the cheeks and
bilaterally by surgical tapes that have orthodontic elastic bands
at one end.
• The elastic on the surgical tape is looped on the retention arm of
the molding plate and the tape is secured to the cheeks.
• The elastics (inner diameter 0.25 in wall thickness-heavy)
should be stretched approximately two times their resting
diameter for proper activation force of about 100 g.
Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with
cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
Appliance adjustments
• These adjustments are made by selectively removing the hard acrylic and
adding soft denture base material to the molding plate.
• No more than 1 mm of modification of the molding plate should be made at
one visit.
• The alveolar segments should be directed to its final and optimal position.
• Care must be taken to prevent the soft denture material from building up on
the height of the alveolar crest as this will prevent complete seating of the
molding plate.
Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with
cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
Incorporation of Nasal Stent
• The nasal stent component of the NAM appliance is incorporated when the
width of the alveolar gap is reduced to about 6 mm.
• The rationale for delaying addition of the nasal stent is that as the alveolar
gap is reduced, the base of the nose and the lip segment alignment is also
improved.
• The alar rim, which at birth was stretched over a wide alveolar cleft
deformity, will show some laxity as the cleft segments are brought together.
• Once the alar base on the cleft side shows less stretch and tension, it can be
elevated into symmetrical and convex form with the nasal stent and not be
subjected to additional stretch.
Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with
cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
Incorporation of Nasal Stent
• When the nasal stent is introduced to a nostril
that is overlying a very wide alveolar gap, it
may stretch further the nostril rim and increase
nostril circumference.
• This may result in a postsurgical “mega-nostril”
or a nostril of greater circumference on the cleft
side than the noncleft side.
• The nasal stent is made of 0.36 inch round
stainless steel wire and takes the shape of a
“Swan Neck”.
Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with
cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
Incorporation of Nasal Stent
• The stent is attached to the labial flange of the molding plate, near the base
of the retention arm.
• It extends forward and then curves backwards (in the form of a swan neck)
entering 3–4 mm past the nostril aperture.
• As the wire extends into the nostril, it is curved back on itself to create a
small loop for retention of the intranasal portion of the nasal stent.
• The hard acrylic component is shaped into a bi-lobed form that resembles a
kidney
Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with
cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
Incorporation of Nasal Stent
• The upper lobe enters the nose and gently projects the dome forward until a
moderate amount of tissue blanching is evident.
• The lower lobe of the stent lifts the nostril apex and defines the top of the
columella
Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with
cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
Nonsurgical columella lengthening in
patients with bilateral cleft lip and
palate
• In patients with bilateral cleft lip and palate, there is a need
for two retention arms as well as two nasal stents, which are
similar in shape to the unilateral stent.
• The initial goal of molding is to center the premaxilla, retract
the premaxilla and reduce the bilateral cleft gaps to 5–6 mm
prior to adding the nasal stents
Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with
cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
• The first goal of PNAM in bilateral cases is to move the premaxillary
segment posteriorly and medially, while preparing the lateral alveolar clefts
to come in contact with the premaxilla.
• The posterior lateral palatal shelves are molded to the appropriate width to
accept the premaxilla. The premaxilla is retracted and derotated as
necessary using the molding plate in conjunction with external tape and
elastics.
Nonsurgical columella lengthening in
patients with bilateral cleft lip and
palate
• A horizontal band (columella band) of denture material is added to join the
left and right lower lobes of the nasal stent, spanning the columella.
• The inferior surface of the columella band sits at the nasolabial junction and
helps to define this angle.
• The superior surface of the columella band presses up against the nostril
apex, located at the top of the columella.
Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with
cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
Nonsurgical columella lengthening in
patients with bilateral cleft lip and
palate
• Tape is adhered to the prolabium underneath the horizontal lip tape and
stretches downward to engage the retention arm with elastics .
• This vertical pull provides a counter stretch to the upward force applied to
the left and right nostril apex of the columella band.
• Taping downwards on the prolabium helps to lengthen the columella and
vertically lengthens the often small prolabium.
Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with
cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
Primary surgical repair of the
alveolus lip and nose
• The alignment of alveolar segments and premaxilla, correction of nasal
asymmetry, elongation of the columella and projection of the nasal tip are
accomplished before the primary surgical repair.
• Surgical closure of the lip and nose is performed from 3 to 4 months of age.
• Achievement of presurgical clinical objectives in patients with bilateral cleft
lip and palate tends to take 1–2 additional months.
Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with
cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
Primary surgical repair of the
alveolus lip and nose
• The surgical technique must be modified to take advantage of the NAM
preparation.
• Approximation of the alveolar segments permits the surgeon to perform
gingivoperiosteoplasty.
• Reshaping of the deformed alar cartilage and stretching of the nasal mucosa
enhances the surgeons ability to achieve a good primary rhinoplasty and
surgical alveolar repair.
Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with
cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
Complications
• Most common problems: irritation to the oral mucosa,
gingival tissue, or nasal mucosa.
• Intraoral tissues may ulcerate from excessive pressure
applied by the appliance.
• The intranasal lining of the nasal tip can become
inflamed if too much force is applied by the upper lobe of
the nasal stent.
• Skin irritation because of the tape.
Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with
cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
Disadvantages of PNAM
Maxillary
growth
restriction
Negative influences
on speech because of
delayed palate
closure
The costs of the
treatment
Complexity of
treatment
Lip surgery alone
has the same effect
as that of PSIO
The therapeutic
implication of presurgical
orthopedics is not growth
guidance but
repositioning of the
maxillary segments
(Kriens, 1989).
Opponents of the
approach also state that
PSIO is ineffective and
unnecessary (Subtelny,
1964; Pruzansky and
Aduss, 1964; Berkowitz,
1990).
(Pruzansky and Aduss, 1964; Huddart and Bodenham, 1972; Ross, 1987;
Kramer et al. 1992; Prahl et al., 2001).
Controversies with
PNAM
Long Term Effects of
PSIO
Facial growth, maxillary arch, and
dentition and occlusion
Proponent
• Mishima et al.,using a two-group
quasirandomised design with a control group
(n = 8) children without PSIO, found that prior
to lip surgery the maxillary segments in the
PSIO group (n = 12) moved towards the midline,
and in the non-PSIO group, the maxillary
segments remained in the same position or
displaced laterally. At 18 months of age, the
curvature of palatal shelves was less steep, and
there was less arch collapse in PSIO group when
compared with control group. At 4-years of age,
the distance between deciduous canines and
second deciduous molars was larger in the PSIO
group; other variables did not differ between the
two groups.
Opponent
• Lee et al. assessed the effects of NAM
and gingivoperiosteoplasty (GPP) in 20
UCLP patients at 6-year and at 11.5-
year that is, at pre-pubertal age using
lateral cephalogram and found that
midface growth in sagittal or vertical
planes (up to the age of 9-13 years) was
not affected by pre-surgical alveolar
moulding and GPP.
Niranjane, P.P., Kamble, R.H., Diagavane, S.P., Shrivastav, S.S., Batra, P., Vasudevan, S.D. and Patil, P., 2014. Current status of presurgical infant
orthopaedic treatment for cleft lip and palate patients: A critical review. Indian Journal of Plastic Surgery: Official Publication of the Association of
Plastic Surgeons of India, 47(3), p.293.
Nasal symmetry and nasolabial appearance
Proponent
• In a 6-year follow-up by Bennun et
al. to compare growth and cosmetic
results of 97 UCLP patients using
plaster models by using surface
impressions of the babies revealed a
better and permanent nostril symmetry,
increase in the columellar length and no
alar cartilage luxation in patients who
had the nasal component.
• A 9-year follow-up by
Barillas et al. using stone cast
measurements in 25 UCLP patients
revealed that the nasal symmetry was
improved by PNAM and was maintained
at 9-year.
Opponent
• Sulaiman et al. did a 15-year follow-up
of pre-surgical orthopaedics, followed by
primary correction for unilateral cleft
lip nose and found that the nostril
height and width ratio and the height of
the alar groove were significantly
improved post-operatively and
maintained for 15-years, but also stated
that repositioning of nasal cartilage at
infancy might not eliminate need for
secondary correction after puberty.
Niranjane, P.P., Kamble, R.H., Diagavane, S.P., Shrivastav, S.S., Batra, P., Vasudevan, S.D. and Patil, P., 2014. Current status of presurgical infant
orthopaedic treatment for cleft lip and palate patients: A critical review. Indian Journal of Plastic Surgery: Official Publication of the Association of
Plastic Surgeons of India, 47(3), p.293.
Speech
Proponent
• Suzuki et al. studied the effect of pre-
operative orthopaedic plate on
articulatory function in 17 CLP
children. Speech was assessed by
speech therapists 3-year 11 months
after palatoplasty. The results
indicated that the continuous use of
orthopaedic plate was effective in
preventing palatalized articulation.
Opponent
• Konst et al. evaluated language skills
of children between the ages of 2 and
6-year. The results showed that the
early positive effects of PSIO changed
over time, and no differences were
found in language development
between the two groups at the age of
6-years.
Niranjane, P.P., Kamble, R.H., Diagavane, S.P., Shrivastav, S.S., Batra, P., Vasudevan, S.D. and Patil, P., 2014. Current status of presurgical infant
orthopaedic treatment for cleft lip and palate patients: A critical review. Indian Journal of Plastic Surgery: Official Publication of the Association of
Plastic Surgeons of India, 47(3), p.293.
• Liou et al. reported that nasal asymmetry was significantly improved after
nasoalveolar molding in infants with cleft lip and palate; but after the
primary closure of the cleft lip and nose, there was a significant relapse of
the nasal asymmetry in the first year postsurgery, which remained stable
afterwards. This relapse was the result of a significant differential growth
between cleft and noncleft sides in the first year postsurgery.
• Pai et al., who used the nasoalveolar molding (NAM) appliance in their
study, concluded that there was some relapse of nostril shape in width
(10%), height (20%), and angle of columella (4.7%) at 1 year of age, compared
to their presurgical status.
• Papadopoulos et al. also investigated the effectiveness of presurgical infant
orthopedics using a systematic review. They showed that there were no
significant differences in craniofacial and dentoalveolar changes, indicating
that PSIO treatment had no effect on cleft lip and palate patients.
3) Esenlik E. Presurgical Infant Orthopedics for Cleft Lip and Palate: A Review. Journal of Surgery
[Jurnalul de chirurgie] 2015; 11(1): 9-14. doi:10.7438/1584-9341-11-1-2
Proponents of PNAM
• Aids in the surgical repair of the lip and palate by reducing defect width of the palatal and
alveolar ridge, which in turn will reduce lip tension and benefits wound healing
postoperatively
• Prevents initial collapse after surgery and crossbites
• Achieves symmetrical arch form
• Improves position of alar base
• Less extensive orthodontic treatment at later ages
Surgery
• Improved growth of the maxilla as repositioning of the bony segments will help
in future growth and development
• Reduced tongue interference with the palatal shelves may encourage the
normal growth of the palatal shelves, thus allowing spontaneous reduction in
the width of the cleft
Growth
• Improved speech development due to improved physiological tongue function and position
(prevents twisting and dorsal position of the tongue in the cleft).
• The improvement was significant in children aged 1–3 years; this was seen as the ability of the
child to produce longer sentences. However, this improvement diminished in children aged 6
years
• Improved feeding (less danger of aspiration); however, there is no evidence to support this
• Better nose breathing and decreased nasal regurgitation
• A positive psychological effect on the parents
Function
Alzain, I., Batwa, W., Cash, A. and Murshid, Z.A., 2017. Presurgical cleft lip and palate orthopedics: an overview. Clinical, cosmetic and investigational dentistry, 9, p.53.
Opponents of PNAM
• Neonatal maxillary orthopedics is a complex and expensive
therapy that is ineffective and unnecessary because parents are
obliged to travel frequently to the treatment center and endure an
increased burden of care.
• There is no significant improvement in parents’ satisfaction.
• The overall cost of treatment is significantly high.
Cost-
Effectiveness
•Neonatal maxillary orthopedics restricts maxillary development as a
result of the molding process
•There are no apparent long-term effects on facial growth in either
vertical or anteroposterior dimensions.
•However, there is some evidence emerging that those patients who have
had NAM do have improved nasal anatomy.
Growth
• Influences speech negatively due to delayed surgery of the hard
palate.
• It is not necessary for feeding or orthodontic reasons,did not
improve feeding efficiency or general body growth,and did not
improve deviated swallowing characteristics.
Function
Alzain, I., Batwa, W., Cash, A. and Murshid, Z.A., 2017. Presurgical cleft lip and palate
orthopedics: an overview. Clinical, cosmetic and investigational dentistry, 9, p.53.
A newer classification system
(Daigavane P S, Hazarey PV, Niranjane P, Vasudevan SD, Thombare BR, Daigavane S. A New Classification System for Unilateral Cleft
Lip and Palate Infants to assist Presurgical Infant Orthopedics. The Journal of Clinical Pediatric Dentistry . Volume 39, Number 3/2015)
Type Model Features Treatment Plan
Type A Greater and lesser segment are of
sufficient length
1. Well expanded tuberosities are used for support.
2. Soft liner is placed on the anterior 1/3rd
3. Equal amount of the acrylic is removed from the
opposite side of the segment to make space for the
alveolar segment to move.
Type B Greater segment is of sufficient
length but lesser segment is small
and/or placed posteriorly
1. Only the greater segment is molded into an arch
form.
2. An attempt to achieve complete closure of the
alveolar segments may lead to arch constriction.
3. Alveolar Bone Grafting can be done later.
Type C Greater and lesser segments are of
small length and parallel to each
other
1. Transverse width of the arch will be maintained
using permasoft.
2. No attempt must be made to close the alveolar
defect.
3. Later closure can be done with flap, or the defect
can be sealed with an obturator modified with
denture.
Type D Greater segment is overlapping the
lesser segment
1. The “Locked Segments” commonly seen in cases
with cleft lip and alveolus.
2. Consideration should be given to only nasal
molding.
3. Transverse growth of the maxilla will unlock the
overlapping to attain arch uniformity.
Pre-directional
appliance: A new
approach to correct
shifted premaxilla in
bilateral cleft cases
Daigavane, P.S., Hazarey, P., Vasant, R. and Thombare, R., 2011. Pre-
directional appliance: A new approach to correct shifted premaxilla in
bilateral cleft cases. Journal of Indian Society of Pedodontics and
Preventive Dentistry, 29(6), p.39.
Introduction
• Management of bilateral cleft lip and palate cases is a
challenging task, and if the premaxilla is shifted to either
side, it poses a problem for the surgeon to operate and
also for the orthodontist to do the orthodontic alignment.
• The aim of this study was to reposition the shifted
premaxilla for better retraction with presurgical infant
orthopedics, thus reducing the tissue tension and further
scarring which have detrimental effects on maxillary
growth.
• The innovative technique with pre-directional (PD)
appliance is easy to fabricate and use and works in this
direction.
Case Report
Method of Fabrication
• Pre-directional (PD) appliance, fabricated in heat-cure
resin, is a modification of Grayson's presurgical naso
alveolar molding (PNAM) appliance.
• To make the anterior segment flexible, the appliance was
modified by marking two parallel vertical lines and a
transverse cut was given in the anterior segment of the
appliance to separate it from the posterior segment.
• 1 mm acrylic was reduced from edges of both the
segments.
• With the straight fissure
bur, cuts were made on the
vertical lines.
• Both these segments were
repositioned on the cast; two
8-mm NITI coil springs were
placed in the vertical cuts
and rejoined with self-cure
resin.
• Permasoft was applied on the inner surface of
the anterior segment on the right side to push
the premaxilla to left side, and also, on the
medial aspect of the posterior alveolar
segment for expansion.
• The appliance was retained with tapes (3M
micropore surgi tape) and red elastics.
• The elastic force on both sides differed; on the
right side it was kept inactive for appliance
stability, while on the left side it was
stretched double its diameter, exerting a force
of 6 ounces on the premaxilla. The patient
was evaluated weekly for correction.
Results
• On evaluation after
2 months 20 days,
the premaxilla was
shifted to the left
side by 5.5 mm, the
premaxilla and
prolabium were
positioned in the
middle, facial
symmetry was
observed with both
the nostrils equally
visible
• .At this stage, the PD appliance was
replaced by Grayson's PNAM
appliance. Nasal stents were added for
molding.
• For prolabium lengthening, a vertical
tape was overlapped on two red
elastics (knotted with eachother)
placed on retentive buttons.
• During suckling, stent forces the nose
dome upward and forward, while the
lip tape forces the prolabium
downward, thus lengthening the
columella.
• It was observed that after 2½ months,
the premaxilla was retracted 4.5 mm
uniformly with successful nasal
molding.
• At 6½-7 months of age, both side lips
were operated in the same operative
session with Millard and Nordoff
technique.
• On evaluation, at the age of 1 year 3
months, it was observed that facial
symmetry, columellar lengthening, and
nasal molding were maintained.
• As this appliance could reposition the premaxilla within
short duration, it was possible to do nasal molding
utilizing the elasticity of the nasal cartilage.
• Alveolar segments were expanded to 1.5 mm, premaxilla
was retracted symmetrically by 4.5 mm, facial esthetic
was improved, prolabium was lengthened to 6 mm, no
tissue tension was observed during surgery and
satisfactory lip repair was accomplished in one stage
Advantages
• Inexpensive
• Easy to fabricate
• Does not require complicated laboratory procedures
• Gives quick results
• The rate of bone healing is inversely proportional to size
of defect; thus, presurgical orthopedics favors bone
formation.
Conclusion
• Treatment outcomes, and favorable or unfavorable
maxillary growth, may be anticipated according to initial
severity of the cleft deformity and less related to the
given treatment.
• More importantly, because there is a demonstrated
variation in severity of cleft deformity, treatment protocol
could vary according to severity of the initial deformity
and children with CLP could be sorted by severity before
correlating specific treatment variables with outcomes.
Bibliography
• Murray, J.C., 2002. Gene/environment causes of cleft lip and/or palate. Clinical
genetics, 61(4), pp.248-256.
• Murthy P S, Deshmukh S, Bhagyalakshmi A, Srilatha K T. Pre Surgical Nasoalveolar
Molding: Changing Paradigms in Early Cleft Lip and Palate Rehabilitation. J Int Oral
Health 2013; 5(2):76-86.
• Contemporary Orthodontics: William R. Profitt (5th edition)
• Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol
in patients with cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-
267). Elsevier.
• Grayson, B.H. and Cutting, C.B., 2001. Presurgical nasoalveolar orthopedic molding in
primary correction of the nose, lip, and alveolus of infants born with unilateral and bilateral
clefts. The Cleft palate-craniofacial journal, 38(3), pp.193-198.
• Niranjane, P.P., Kamble, R.H., Diagavane, S.P., Shrivastav, S.S., Batra, P., Vasudevan, S.D.
and Patil, P., 2014. Current status of presurgical infant orthopaedic treatment for cleft lip
and palate patients: A critical review. Indian Journal of Plastic Surgery: Official Publication
of the Association of Plastic Surgeons of India, 47(3), p.293.
• Singla, S. and Kaur, M., 2008. Cleft palate habilitation. The Indian Journal
of Pediatrics, 75(7), pp.703-708.
• Kalaskar, R., Kalaskar, A., Naqvi, F.S., Tawani, G.S. and Walke, D.R., 2013.
Prevalence and evaluation of environmental risk factors associated with cleft lip
and palate in a central Indian population. Pediatric dentistry, 35(3), pp.279-283.
• Textbook of Oral and Maxillofacial Surgery – Neelima Anil Malik (3rd
edition)
(Daigavane P S, Hazarey PV, Niranjane P, Vasudevan SD, Thombare BR, Daigavane S. A
New Classification System for Unilateral Cleft Lip and Palate Infants to assist Presurgical
Infant Orthopedics. The Journal of Clinical Pediatric Dentistry . Volume 39, Number 3/2015)

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Naso alveolar molding treatment protocol in patients with cleft

  • 1. NasoAlveolar Molding Treatment Protocol in patients with Cleft Lip and Palate By Dr. Kritika Suroliya
  • 2. Learning Objectives • What is Pre-surgical Infant Orthopaedics? • What is NasoAlveolar Molding? • Fabrication of the appliance used for NasoAlveolar Molding?
  • 3. Contents: • Introduction to CL/P • Prevalence of CL/P • Classification of CL/P • Anatomy and characteristics of CL/P • Problems Associated with CL/P in children • Pre-Surgical Infant Orthopaedics • History • Principle • Advantages • Disadvantages • The NAM Appliance  Principle  Impression Technique  Appliance Fabrication and Design  Appliance Insertion and Taping  Appliance adjustments  Proponents and Opponents of NAM • The Pre-Directional Appliance • Conclusion
  • 4. Introduction • Facial Clefting is the second most common congenital deformity. • Orofacial Clefts, particularly non-syndromic cleft lip (CL), with or without cleft palate (CLP), and isolated Cleft Palate are the most common craniofacial deformities affecting one in every 700 to 1000 newborns worldwide. • Due to their disturbing appearance in many cases, these deformities have attracted much attention in terms of treatment and research. Murray, J.C., 2002. Gene/environment causes of cleft lip and/or palate. Clinical genetics, 61(4), pp.248-256.
  • 5. Introduction • Cleft lip and palate is one of the common facial deformities that not only affect the aesthetics but also affect the speech and hearing. • Over the years various treatment modalities have been attempted in these patients so as to achieve satisfactory outcome. • Surgical treatment of cleft lip and palate has been documented since 317AD, when Chinese General Wei Yang Chi had his cleft lip corrected by cutting and stitching the edges together. • Since then various authors described the different surgical techniques for correction of cleft lip. Murthy P S, Deshmukh S, Bhagyalakshmi A, Srilatha K T. Pre Surgical Nasoalveolar Molding: Changing Paradigms in Early Cleft Lip and Palate Rehabilitation. J Int Oral Health 2013; 5(2):76-86.
  • 6. Introduction • To further improve the esthetic result of surgical lip repair, the concept of presurgical infant orthopedics was developed. • Presurgical infant orthopedics plays a significant role in neonatal cleft lip and palate treatment. Murthy P S, Deshmukh S, Bhagyalakshmi A, Srilatha K T. Pre Surgical Nasoalveolar Molding: Changing Paradigms in Early Cleft Lip and Palate Rehabilitation. J Int Oral Health 2013; 5(2):76-86.
  • 8. Prevalence • The prevalence for non-syndromic CLP and CP in the Nagpur region was found to be 0.66 percent and 0.27 percent, respectively. • Most of the worldwide studies showed male predominance for CLP and CP. In the present study, however, females outnumbered males. Kalaskar, R., Kalaskar, A., Naqvi, F.S., Tawani, G.S. and Walke, D.R., 2013. Prevalence and evaluation of environmental risk factors associated with cleft lip and palate in a central Indian population. Pediatric dentistry, 35(3), pp.279-283.
  • 10. Classification Cleft lip with or without clefting of the alveolar process (cleft of the primary palate) (CL): • The alveolar ridge is intact • The cleft involves the height of the lip to some degree. • The cleft lip may be unilateral or bilateral.
  • 11. Classification Isolated Cleft Palate (CP): • Both the soft palate and hard palate are divided. • A complete palatal cleft is classified as unilateral if the vomer is attached to one of the palatal shelves. • When the vomer is totally separated from the palatal shelves, its lower free border can be detected between them, the cleft is then classified as bilateral, although it remains median.
  • 12. Classification Combined cleft lip and palate (UCLP and BCLP): • Subjects with combined cleft lip and palate have clefts in both primary and secondary palate. • The cleft formation may be complete, or incomplete; unilateral or bilateral. • Although the palatal cleft is always median, rotation of the vomer may cause it to appear lateral.
  • 13. David and Ritchie Classification (1922) • Group 1: Pre-alveolar clefts (unilateral, bilateral and median) • Group 2: Post alveolar clefts • Group 3:Complete alveolar clefts (unilateral, bilateral and median) Textbook of Oral and Maxillofacial Surgery – Neelima Anil Malik (3rd edition)
  • 14. Veau (1931) • Group 1: Cleft of the soft palate only • Group 2: Cleft of the hard and the soft palate • Group 3: Complete unilateral cleft, extending from uvula to incisive foramen and then deviates to one side extending through the alveolus • Group 4: Complete bilateral alveolar cleft Textbook of Oral and Maxillofacial Surgery – Neelima Anil Malik (3rd edition)
  • 15. Fogh-Andersen (1942) • Fogh-Andersen (1942) divided oral clefts into 3 main groups: 1) CL including clefts of the lip and alveolus 2) CL and CP including unilateral and bilateral cleft lip and palate. 3) CP being median and not extending beyond the incisive foramen. Textbook of Oral and Maxillofacial Surgery – Neelima Anil Malik (3rd edition)
  • 16. Kernahan and Stark (1958) Textbook of Oral and Maxillofacial Surgery – Neelima Anil Malik (3rd edition)
  • 17. Internationally Approved Classification (1967), following Rome Congress Textbook of Oral and Maxillofacial Surgery – Neelima Anil Malik (3rd edition)
  • 18. Jensen et al (1988) • Jensen et al (1988) divided the cleft palate into 4 grades to describe the extent of the cleft palate into 4 grades: 1) Grade 1: soft palate 2) Grade 2: one-third of hard palate 3) Grade 3: More than one-third of hard palate 4) Grade 4: Total Textbook of Oral and Maxillofacial Surgery – Neelima Anil Malik (3rd edition)
  • 19. A new Classification system by Daigavane et al (2015) Type A: Greater and Lesser segment are of sufficient length Type B: Greater alveolar segment is of sufficient length but lesser alveolar segment is small and/or placed posteriorly Type C: Greater and lesser segments are of small length or parallel to each other Type D: Greater segment is overlapping the lesser alveolar segment (Daigavane P S, Hazarey PV, Niranjane P, Vasudevan SD, Thombare BR, Daigavane S. A New Classification System for Unilateral Cleft Lip and Palate Infants to assist Presurgical Infant Orthopedics. The Journal of Clinical Pediatric Dentistry . Volume 39, Number 3/2015)
  • 21. Unilateral Cleft Lip and Palate • The lip, nose and alveolus have a cleft at the right or the left side. • The cleft then continues into the palatal part of the maxilla and separates the palatal bone at the level of the nasal septum. • The alveolar arch and palate are separated into a large and a small segment. • The segments are often laterally displaced and the anterior end of the larger segments protrudes, and there is a midline shift to the non-cleft side. • The smaller segment is usually located dorsally and the anterior part is slightly curved upwards, compared to the larger segment.
  • 22. Unilateral Cleft Lip and Palate • Severe deviation of the noncleft side of the maxilla away from the cleft, carrying with it the nasal structures including the nasal septum. • This distortion is the response of inadequately supported bone structures to pressure.
  • 23. Unilateral Cleft Lip and Palate • Abnormal insertion of the cheek muscles on the maxilla at the base of the nose causes a rotating force on the larger segment during muscle contraction. • This action is reinforced by tongue protrusion. • The smaller segment on the cleft side is exposed to less expanding force,& has a mild contracting force exerted by the base of the nasal ala on this side.
  • 24. Unilateral Cleft Lip and Palate • Wide nostril base • Separated lip segments • Increased alar rim • Oblique columella • Overhanging nostril apex • Nose is deviated toward normal side • Except for alar base on cleft side, nostril is stretched and straightened • The affected lower lateral nasal cartilage is displaced laterally and inferiorly, which results in a depressed dome Murthy P S, Deshmukh S, Bhagyalakshmi A, Srilatha K T. Pre Surgical Nasoalveolar Molding: Changing Paradigms in Early Cleft Lip and Palate Rehabilitation. J Int Oral Health 2013; 5(2):76-86.
  • 25. Bilateral Cleft Lip and Palate • The lower lateral cartilages fail to migrate up into the nasal tip to stretch the columella. • The prolabium also lacks muscle tissue and is positioned directly on the end of the shortened columella. • The alar cartilages are positioned along the alar margins and are stretched over the cleft in a flared fashion. • In a complete BCLP, the premaxilla is suspended from the tip of the nasal septum, whereas the lateral alveolar segments remain behind.
  • 26. Bilateral Cleft Lip and Palate • Underdeveloped contralateral philtral ridge • Ill-defined Cupid's bow, thin vermilion-mucosa on both sides of the cleft. • Protruding prolabium, demonstrates total absence of orbicularis oris and seems to be joined directly to the tip of the nose.
  • 27. Bilateral Cleft Lip and Palate • The premaxilla relatively unsupported on nasal septum, is not able to resist force of active tongue and tilts forward. • If tongue habitually protrudes through one side, then premaxilla is protruded and forced to opposite side, giving the asymmetry. • The premaxilla is unrestrained by attachment to either segment of the maxilla & is projected forward by the growth of the cartilagenous septum.
  • 28. Isolated Cleft Palate (CP) • In isolated cleft palate, the extent of the cleft varies. • The cleft can be submucous characterised by a bifid uvula, a notch in the posterior hard palate and a muscular sling that is not united. • The cleft can extend only into the soft palate or extend with varying degrees into the hard palate. • In complete cases, the cleft extends all the way to the incisive foramen.
  • 29. Simonart’s bands • In some patients, lip clefting is not complete, but a soft tissue bridge is located either at the base of the nostril or between the segmented alveolar ridges. • The soft tissue bridges are known as Simonart’s bands and can be present in either unilateral or bilateral clefts.
  • 31. •Nostril Defect: From mild Nose Asymmetry to gross defect of nasal cartilage and septum •Short columella, hypoplastic maxilla, short premaxilla and prolabium Aesthetics • In Pierre Robin Syndrome, along with cleft palate, there is mandibular micrognathia and glossoptosis. The underdeveloped mandible results in tongue fall in the oropharynx, airway obstruction of the child. Airway Obstruction •Structural defects prevent negative oral pressure for effective sucking. •Normal Palate function is necessary for deglutition Feeding Textbook of Oral and Maxillofacial Surgery – Neelima Anil Malik (3rd edition)
  • 32. Dental Problems Impaired Speech Auditory Problems • Congenitally absent/supernumerary teeth • Crowding/ displacement of teeth • Morphologically deformed/ hypomineralised teeth • Impaired velopharyngeal mechanism leading to hypernasal speech. • Retardation of consonant sounds (p,b,t,d,k and g) • The levator and tensor muscles of the soft palate affect the opening of the auditory tube, increasing susceptibility to middle ear infections. • Additional hazard of lymphoid hyperplasia over the auditory tube orifice in the nasopharynx Textbook of Oral and Maxillofacial Surgery – Neelima Anil Malik (3rd edition)
  • 33. Role of an orthodontist? • The craniofacial orthodontist is involved in the life of a patient born with a craniofacial deformity and/or cleft lip and palate from birth through skeletal maturity. • This may include infant presurgical orthopedics, early mixed dentition treatment, dentofacial orthopedics and orthodontics, preparation for alveolar bone graft procedures, adolescent/adult orthodontics, preprosthetic orthodontics, and pre- and postsurgical orthodontics. Santiago, P.E. and Grayson, B.H., 2009, December. Role of the craniofacial orthodontist on the craniofacial and cleft lip and palate team. In Seminars in Orthodontics (Vol. 15, No. 4, pp. 225-243). Elsevier.
  • 34. Treatment Protocol associated with treatment of cleft children 2-4 weeks: Lip Closure (Infant Orthopaedics) 12-18 months: Palate Closure 7-8 years: Alignment of maxillary incisors 7-9 years: Alveolar bone graft (before eruption of lateral incisor, if present, or canine) Adolescence: Comprehensive Orthodontics, Lip/nose revision? Late Adolescence: Orthognathic Surgery Contemporary Orthodontics: William R. Profitt (5th edition)
  • 35. Eurocleft Protocol • Clefts of the lip, alveolus and/or palate affect between 1 per 500 to 1 per 700 live births in Europe (World Health Organization, 1998). • Approaches to cleft care in Europe vary considerably between countries. Within the Nordic countries there is a tradition of centralization of services. Other countries such as France, Germany and Italy (and until recently, the UK) provide cleft care via large numbers of local services who may see but a few patients with clefts.
  • 36. A Six-Center International Study Of Treatment Outcome in Patients with Clefts of Lip and Palate •Part 1: Principles and Study Design •Part 2 : Craniofacial form and soft tissue profile. •Part 3 : Dental Arch Relationships •Part 4 : Assessment of nasolabial apperance •Part 5 : General discussion and conclusion Shaw, W.C., Dahl, E., Asher-Mcdade, C., Brattström, V., Mars, M., Mcwilliam, J., Mølsted, K., Plint, D.A., Prahl-Andersen, B., Roberts, C. and Semb, G., 1992. A six-center international study of treatment outcome in patients with clefts of the lip and palate: Part 5. General discussion and conclusions. The Cleft palate-craniofacial journal, 29(5), pp.413-418.
  • 37.
  • 38. Americleft Protocol • In 2006, the Executive Council of ACPA approved funds for the Research Education Committee to organize a pilot project which has become “Americleft”, an ACPA Task Force. • Six centers were identified to participate in the pilot project which resulted in 3 face-to-face meetings over the past two years, completion of initial comparisons of dental arch relationship outcomes, cephalometric morphology outcomes, nasolabial esthetic outcomes and the protocol for assessing speech outcomes. • The results of these have all confirmed the value and benefits of well- controlled and well-designed inter-center outcome comparisons. Americleft study guide
  • 39.
  • 40. Sawangi Protocol for Treatment of Cleft Lip and Cleft Palate Birth: Initial Assessment Pre-surgical assessment (PNAM) 8-9 year: Initial Interventional Orthodontics Preparation of Alveolar Bone Grafting 3 Month: Primary Lip repair 10 years: Alveolar Bone Graft 9-18 Month: Palate Repair 12-14years: Definite Orthodonti cs 2 year: Speech Assessment 16 years: Nasal Revision Surgery 3-5 year: Lip Revision Surgery 17-20 years: Orthognath ic Surgery
  • 41. Infant Orthopaedics • In children, with severe distortion of the maxillary arches, surgical closure of the lip which is carried out in the early weeks of life, can be extremely difficult. • Orthodontic intervention to reposition the segments and to bring protruding premaxillary segment back into the arch may be needed to obtain a good surgical repair of the lip. • This “infant orthopaedics” is one of the few instances in which orthodontic treatment for a newborn infant, before the eruption of any teeth, may be indicated. Contemporary Orthodontics: William R. Profitt (5th edition)
  • 43. Definition • PSIO is defined as any orthopedic manipulation of the segments of the clefted maxilla in a newborn with complete unilateral or bilateral CLP aiming at establishing a more normal maxillary alveolar arch form or at retracting a protruding premaxilla to facilitate the surgical repair of lip.(Glossary of Orthodontic terms, 2000)
  • 44. Pre-Surgical Infant Orthopaedics • Presurgical Infant Orthopaedics has been used in the treatment of cleft lip and palate patients for centuries. • Early techniques focused on elastic retraction of the protruding premaxilla followed by stabilization after surgical repair. Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
  • 45. Pre-Surgical Infant Orthopaedics (PSIO) • This concept was introduced at University of Glasgow by Kerr McNeil in 1954 as an adjunctive neonatal therapy aiming at nonsurgical reduction of the size of the alveolar cleft. • The rationale behind “Maxillary Orthopedics” as described by McNeil, Burston and Rosenstein is that early segment alignment will allow the maxillary halves to develop normally even though a normal bony union is not present. • The primary purpose of the appliance prior to lip closure is not to proliferate tissue or initiate growth but to guide the maxillary segments into proper spatial position with each other and with the mandibular arch. Singla, S. and Kaur, M., 2008. Cleft palate habilitation. The Indian Journal of Pediatrics, 75(7), pp.703-708.
  • 46. Advantages of PSIO Surgical benefits: • Allows a surgical cleft closure without tension and mobilization of the surrounding soft tissue. • In complete unilateral clefts of primary and secondary palate, the defective oropharyngeal musculature allows unrestricted lateral and superior rotation of the maxillary segments in a medial and inferior direction and recontour the greater segment, restoring a normal premaxillary- maxillary arch relationship and thus facilitating surgical repair of cleft lip. • In case of bilateral clefts, the premaxilla is rotated superiorly and anteriorly and the maxillary segments are retruded and rotated medially and superiorly. Repair of lip without first repositioning the segments of the maxilla would lock the premaxilla outside the maxillary segments in a forward position. This allows the lower lip to fall behind the premaxilla, retruding the mandible, allowing overdevelopment of the premaxillary alveolar area and creating an excessive overbite. Singla, S. and Kaur, M., 2008. Cleft palate habilitation. The Indian Journal of Pediatrics, 75(7), pp.703-708.
  • 47. Advantages of PSIO • An Orthopaedic feeding appliance facilitates the correction by expanding the maxillary buccal segments and retruding the premaxilla with or without external strappings. • The constant gentle pressure of the appliance against the palatal tissues serves as a stimulus for the growth of underlying bone. This results in a narrowing of the palatal cleft and greatly benefits surgical repair. • Another advantage is reduction in width of the cleft in the alveolar process which means that there is more chance of the segments forming a butt joint in the alveolar process region and possibility of an over contracted upper arch after lip repair is therefore, reduced. Singla, S. and Kaur, M., 2008. Cleft palate habilitation. The Indian Journal of Pediatrics, 75(7), pp.703-708.
  • 48. Advantages of PSIO Aid to plastic surgeon: • The orthopedic repositioning of the premaxillary region of the greater segment, and the repositioning of the premaxilla restore the skeletal base under the nose and lip to a more normal position and permit a more aesthetic reconstuction of the cleft lip. The better the original correction of the lip, the less likelihood there is of secondary surgical correction Singla, S. and Kaur, M., 2008. Cleft palate habilitation. The Indian Journal of Pediatrics, 75(7), pp.703-708.
  • 49. History 1) Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier. 3) Esenlik E. Presurgical Infant Orthopedics for Cleft Lip and Palate: A Review. Journal of Surgery [Jurnalul de chirurgie] 2015; 11(1): 9-14. doi:10.7438/1584-9341-11-1-2 2) Bilgic F, Sozer OA. Diagnosis and presurgical orthopedics in infants with cleft lip and palate. Eur J Gen Dent 2015;4:41-7
  • 50. History • 1689- Hoffman demonstrated the use of facial binding to narrow the cleft and reduce post surgical dehiscence. • 1790- Similar technique was shown by Desault • 1844- Hullihen stressed the importance of presurgical preparation of clefts using an adhesive tape binding. • 1844- Esmarch and Kowalzig used a bonnet and strapping to stabilize the premaxilla after surgical retraction. • 1927- Brophy demonstrated the passing of a silver wire through both the ends of the cleft alveolus, and then progressively tightened the wire Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
  • 51. McNeil Method (1950) • The modern school of cleft lip and palate was started by McNeil. • McNeil was the first in aligning presurgically the alveolar parts in cleft lip and palate patients. • He suggested the use of serial appliances to approximate cleft alveolar segments. • By molding the palatal segments into the correct position using a series of acrylic plates, McNeil believed that this would produce a normal maxilla, while reducing the alveolar and palatal cleft at the same time. • McNeil and Burston claimed that soft tissues overlying the hard palate were stimulated to grow, and they also added that neonatal maxillary orthopedics could control and modify the postnatal development of the maxilla.
  • 52. Latham Device (1975) • Georgiade and Latham introduced a pin retained active appliance to simultaneously retract the premaxilla and expand the posterior segments, which is followed by alveoloperiosteoplasty and lip adhesion. • According to Drs. Latham and Millard, these alignments allow the performance of gingivoperiosteoplasty (GPP), providing stabilization of the maxillary segments and reconstruction of the nasal floor. • Also known as the dentomaxillary advancement (DMA) appliance
  • 53. Latham Device (1975) • The appliance is surgically placed anywhere from 2 to 5 months of age. • The Latham appliance works by simultaneously applying pressure to the cleft segments over a 4 to 6 week period to move the alveolar segments into proper position. • However, an anterior as well as a posterior cross-bite is an unwarranted side effect that may occur more frequently
  • 54. Latham Device (1975) • Bercowitz et al. reported a longitudinal study in unilateral and bilateral cleft lip and palate treated with the Latham device. They also performed periosteoplasty in all cases, and compared the results to patients treated with a non-orthopedics procedure without GPP, and treated just with a lip adhesion method. They found a higher frequency of anterior and posterior crossbite in the presurgical orthopedics group. • Dr. Latham applied the Latham device with less extensive surgery in cases of bilateral cleft lip and palate, and he assessed their dental occlusion and lateral head radiographs at 5 years of age. He found greater values for cephalometric measures in maxillary length, maxillary prominence, and ANB angle compared to previous cases
  • 55. Hotz Appliance (1987) • Hotz et al. described the use of a passive orthopaedic plate to slowly align the cleft segments. • Also known as the Zurich approach. • Arch alignment is achieved by grinding away the acrylic in specific areas. • According to Hotz and Gnoinski, the primary aim of presurgical orthopedics is not to facilitate surgery or to stimulate growth, as postulated by McNeil, but to take advantage of intrinsic developmental potentials.
  • 56. Hotz Appliance (1987) • There are studies that have shown that this appliance has failed to prevent collapse of the alveolar segments
  • 57. Hotz Appliance (1987) • Therefore, the Zurich approach, after a lip operation is performed at the age of 6 months, palate repair is postponed until 5 years of age. • In a long term study, Silvera et al. concluded that The two-stage palatoplasty in combination with application of the Hotz plate had good effects on the maxillary growth than one stage palatoplasty without Hotz plate up to the age of 12 years.
  • 58. Grayson’s Technique (1993) • Grayson et al. described a new technique to pre surgically mold the alveolus, lip and nose, in infants born with cleft lip and palate. • PNAM has become very popular among orthodontists because of its nasal molding effect. • It is also suggested to correct septal deviation in early ages without surgery.
  • 59. Grayson’s Technique (1993) • Grayson pointed out that multiple nasal surgical revisions are often indicated to approximate the nasal symmetry, because surgical techniques for managing nasal deformity are lacking. • He also pointed out that in bilateral cleft lip and palate (BCLP), the deficient columella and ectopic premaxilla are the primary reconstructive challenges. Multiple nasal surgeries are required, which often result in excessive scarring at the columella-prolabial junction, and lack of nasal projection. • Therefore, he emphasized the importance of nasal molding before surgery in the early neonatal period.
  • 60. DynaCleft and Nasal Elevators • DynaCleft® is a premade nasal and alveolar molding device which can be used to successfully mold the upper lip, alveolus and nose prior to cleft lip repair. • Unlike tape, DynaCleft offers the benefit of being able to provide a constant approximation force with an elastic center that allows it to conform to a baby’s mouth better because of its ability to expand and contract. • Additionally, the controlled force that it provides to the prolabium and premaxilla could improve surgical results and decrease the necessity of early lip adhesion surgery Vinson, L.A., 2016. Presurgical orthopedics in cleft lip and palate care. Open J Dent and Oral Med, 4, pp.14-19.
  • 61. Vinson, L.A., 2016. Presurgical orthopedics in cleft lip and palate care. Open J Dent and Oral Med, 4, pp.14-19.
  • 62. Classification of PSIO Appliances Huener&Liu(1993) Active or Passive Pre-Surgical and Post- Surgical Intra-Oral or Extra-oral Murthy P S, Deshmukh S, Bhagyalakshmi A, Srilatha K T. Pre Surgical Nasoalveolar Molding: Changing Paradigms in Early Cleft Lip and Palate Rehabilitation. J Int Oral Health 2013; 5(2):76-86. EuropeanCleft Association-ECA(1999) Active Semi-Active Passive
  • 63. Active Appliances Active appliances mold the separate alveolar processes into position by applying active forces on them or, in other words, by directing them to grow or to be moved into a preplanned position. Figure 5 Active appliance, designed to expand and to move the lesser alveolar segment laterally. Notes: (A) The two alveolar segments are not aligned as shown by the red doted lines. (B) An acrylic appliance was placed (red shaded area) and as a result of molding the greater alveolar segment was moved towards the lesser one while the lesser segment was moved laterally by expansion to allow this. The green arrows show the direction of movement of both segments. The greater segment may then be retracted and molded into a more natural position. Alzain, I., Batwa, W., Cash, A. and Murshid, Z.A., 2017. Presurgical cleft lip and palate orthopedics: an overview. Clinical, cosmetic and investigational dentistry, 9, p.53.
  • 64. Passive Appliances Figure 6 Passive appliance. Notes: No need to move the smaller alveolar segment laterally; there is enough space for larger segment to mold. (A) The two alveolar segments are not aligned as shown by the red doted lines. (B) An acrylic appliance was placed (shaded area) and as a result of molding the greater alveolar segment was moved towards the lesser one. The green arrow shows the direction of movement of the segments. Note that the lesser segment did not move. (C) The two segments after alignment. Alzain, I., Batwa, W., Cash, A. and Murshid, Z.A., 2017. Presurgical cleft lip and palate orthopedics: an overview. Clinical, cosmetic and investigational dentistry, 9, p.53.
  • 65. Lip Strap/Lip Taping • A combination of intra-oral appliances and/or extra-oral orthopedic strapping can be used in preparation for primary lip and plate surgery. In combination with the intraoral mouth plates, external tapes and elastics may be strapped to the cheeks to provide some external forces in the alveolar molding process. • Elastic forces will exert a retracting, backward pressure against the protruding premaxilla, and careful use of forces on the cleft segments will improve their positions and allow definitive lip skin and muscle repair Alzain, I., Batwa, W., Cash, A. and Murshid, Z.A., 2017. Presurgical cleft lip and palate orthopedics: an overview. Clinical, cosmetic and investigational dentistry, 9, p.53.
  • 66. Alzain, I., Batwa, W., Cash, A. and Murshid, Z.A., 2017. Presurgical cleft lip and palate orthopedics: an overview. Clinical, cosmetic and investigational dentistry, 9, p.53.
  • 68. • The PNAM treatment protocol for cleft patients has been described by Grayson et al (1993) Brecht et al (1995) Grayson and Santiago (1997) And Cutting et al (1998) Presurgical nasoalveolar molding; Grayson et al., Cleft palate craniofacial journal, November 1999, vol 36, No. 6
  • 69. Principle High levels of hyaluronic acid, a component of proteoglycan intracellular matrix, found circulating in infants several weeks after birth Temporary plasticity of the nasal cartilage increases Favourable for active molding and repositioning of the nasal cartilages. Grayson, B.H. and Cutting, C.B., 2001. Presurgical nasoalveolar orthopedic molding in primary correction of the nose, lip, and alveolus of infants born with unilateral and bilateral clefts. The Cleft palate-craniofacial journal, 38(3), pp.193-198.
  • 70. Matsuo’s Concept Auricular cartilage could be molded with permanent results if treatment was started within 6 weeks of life During this period there are high levels of maternal estrogen in the fetal circulation Which triggers an increase in the hyaluronic acid Hyaluronic acid alters the cartilage, ligament and connective tissue elasticity by breaking down intercellular matrix. Levels of estrogen start dropping at 6 weeks of age. Murthy P S, Deshmukh S, Bhagyalakshmi A, Srilatha K T. Pre Surgical Nasoalveolar Molding: Changing Paradigms in Early Cleft Lip and Palate Rehabilitation. J Int Oral Health 2013; 5(2):76-86.
  • 71. Objectives of PNAM • Active molding and repositioning of the deformed nasal cartilages and alveolar processes. • Lengthening of the columella and correcting the position of the philtrum. • Placement of the lip segments in a more anatomically correct position facilitating lip repair without scarring. • Forces exerted on nasal structures while performing alveolar molding permit straightening of columella and correction of alar cartilage displacement. Thereby reducing the number of nasal surgical procedures and improving nasal esthetics. • It has also been suggested by Pritchard (1946) that bone healing was inversely proportional to the size of cleft viz larger the cleft slower is the bone healing. Hence presurgical naso alveolar molding is recommended to produce more favorable bone formation by reducing the size of the cleft. • Reduces the need for secondary alveolar bone grafts. Murthy P S, Deshmukh S, Bhagyalakshmi A, Srilatha K T. Pre Surgical Nasoalveolar Molding: Changing Paradigms in Early Cleft Lip and Palate Rehabilitation. J Int Oral Health 2013; 5(2):76-86.
  • 72. Advantages • Improvement in arch form • Facilitation of surgical closure • Improvement of aesthetic outcome • Facilitation of feeding • Improvement of speech • Elimination of surgical columella reconstruction and the resultant scar tissue in bilateral cleft lip and palate. Niranjane, P.P., Kamble, R.H., Diagavane, S.P., Shrivastav, S.S., Batra, P., Vasudevan, S.D. and Patil, P., 2014. Current status of presurgical infant orthopaedic treatment for cleft lip and palate patients: A critical review. Indian Journal of Plastic Surgery: Official Publication of the Association of Plastic Surgeons of India, 47(3), p.293.
  • 73. Disadvantages • PSIO approaches are complex and expensive and might have an adverse effect on maxillary growth. • Constricted upper maxilla in all 3 dimensions • Development of Crossbites • Uncontrolled mandibular growth if unnoticed • Overlapping of the two segments • Complete closure of the defect with alveolar molding does not allow the surgeon to create perfect nasal floor. Niranjane, P.P., Kamble, R.H., Diagavane, S.P., Shrivastav, S.S., Batra, P., Vasudevan, S.D. and Patil, P., 2014. Current status of presurgical infant orthopaedic treatment for cleft lip and palate patients: A critical review. Indian Journal of Plastic Surgery: Official Publication of the Association of Plastic Surgeons of India, 47(3), p.293.
  • 74. Concept of Gingivoperioplasty • The surgical bridging of the cleft alveolar process with periosteal flap was initially described by Skoog (1965) as a means of stabilizing the separated segments of the maxilla. • Skoog’s technique necessitated wide mucoperiosteal dissection to mobilize the flaps enough to allow for approximation of cleft alveolus as he did not perform pre surgical nasoalveolar molding. • Current technique of gingivoperioplasty introduced by Millard and Latham (1990) is performed after the patients undergo presurgical orthopedic closure of the cleft alveolar gap. Murthy P S, Deshmukh S, Bhagyalakshmi A, Srilatha K T. Pre Surgical Nasoalveolar Molding: Changing Paradigms in Early Cleft Lip and Palate Rehabilitation. J Int Oral Health 2013; 5(2):76-86.
  • 75. Concept of Nasal Molding • According to Millard (1984) clefting is due to disturbance of embryogenesis and proper closure of all involved structures should be achieved as soon as possible to favor normal growth of the face. • Matsuo et al designed a nasal stent for the correction of the nasal deformity. • Another modification as suggested by Grayson was addition of nasal stent in the alveolar molding plate. • Modified extra oral nasal molding appliance was suggested by Doruk C et al (2005). Murthy P S, Deshmukh S, Bhagyalakshmi A, Srilatha K T. Pre Surgical Nasoalveolar Molding: Changing Paradigms in Early Cleft Lip and Palate Rehabilitation. J Int Oral Health 2013; 5(2):76-86.
  • 76. Criteria for Naso Alveolar Molding (NAM) Infants must present for treatment between 2-4 weeks of age NAM is limited to most severe cases and treatment MUST be performed on-site. As per guidelines of Smile Train
  • 77. Candidates for NAM • Infants presenting with extremely wide unilateral clefts and severe nasal deformity. • Infants presenting with bilateral clefts with moderate to severe pre- maxillary protrusion. • Parents should be aware that NAM involves 7-10 follow up visits over a period of approximately 3 months • Committed and motivated parents of infants living far from the treatment facility and unable to return for the required follow-up visits, should be offered facial taping with or without a nasal stent as a treatment option • Information on nutritional/oral hygiene as it pertains to the future dental health of the infant should be provided to parents (post NAM, facial taping). As per guidelines of Smile Train
  • 78. Cases without the need for NAM? • If there is no cleft at hard palate and cleft is a secondary cleft palate involving soft tissues and uvula or if there is no nasal deformity with a cleft forming an alveolar notch without a condition that make nutrition of infant challenging, no preoperative orthodontic treatment is needed. • However, a nutrition plate will be appropriate if there is an isolated cleft palate that makes nutrition of infant challenging. Bilgic F, Sozer OA. Diagnosis and presurgical orthopedics in infants with cleft lip and palate. Eur J Gen Dent 2015;4:41-7
  • 79. NasoAlveolar Molding Appliance • The NasoAlveolar Molding (NAM) Appliance consists of an intraoral molding plate and nasal stents to mold the alveolar ridge and nasal cartilage concurrently. • NAM has been shown to significantly improve the surgical outcome of primary repair in cleft lip and palate patients compared to other techniques of presurgical orthopaedics. Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
  • 80. Impression Technique • Initial impression of the infant with cleft lip and palate is obtained within the first week of birth. • Heavy bodied silicone impression material is used to take the initial impression. • The impression is best taken in a clinical setting that is prepared to handle airway emergency, if at all encountered. • A surgeon is always present during the impression process.
  • 81. Grayson’s Technique • The infant is held upside down and the impression tray is inserted into the oral cavity. • The infant is held in an inverted position to prevent the tongue from falling back and to allow fluids to drain out of the oral cavity. • The tray is seated until the impression material reaches the posterior border of the impression tray, but not beyond. • The impression must adequately cover the anatomy of the upper gum pads and palatal shelves and include the vestibular folds. Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
  • 82. • Infant experiences Pressure on chest and torso. • An extra person was required to hold the child.
  • 83. Other Methods • Prashanth Mishra et al, obtained impression when the infant was awake in a prone position. • Dubey et al made impression of upper arch using ice cream stick and impression compound.
  • 84.
  • 85.
  • 86. Appliance Fabrication and Design • The molding plate is fabricated on the dental stone model. • The plate is made of self-cure acrylic resin. • The plate must be 2–3 mm in thickness to provide structural integrity and to permit adjustments during the process of molding. • A retention button is fabricated and positioned anteriorly at an angle of approximately 40˚ to the plate. This angle is adjusted or optimized to achieve maximum stability on the alveolar ridges. Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
  • 87. Appliance Fabrication and Design • For the appliance employed in the treatment of a unilateral cleft, only one retention arm is used. • The vertical position of the retention arm should be at the junction of the upper and lower lip. • Orthodontic elastics and tapes attached to the retention button secures the molding plate in the mouth, resting on the alveolar ridges and palatal shelves. • A small opening measuring 6–8 mm in diameter is made on the palatal surface of the molding plate to provide an airway in the event that the plate drops down posteriorly. Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
  • 88. Concept of Alveolar Molding • The appliance is selectively grinded in the areas were movement is expected at the same time soft denture liner is added in the region which require molding. • The soft denture liner applies pressure on the alveolar ridge.
  • 89. Appliance Insertion and Taping • The appliance is then secured extraorally to the cheeks and bilaterally by surgical tapes that have orthodontic elastic bands at one end. • The elastic on the surgical tape is looped on the retention arm of the molding plate and the tape is secured to the cheeks. • The elastics (inner diameter 0.25 in wall thickness-heavy) should be stretched approximately two times their resting diameter for proper activation force of about 100 g. Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
  • 90.
  • 91. Appliance adjustments • These adjustments are made by selectively removing the hard acrylic and adding soft denture base material to the molding plate. • No more than 1 mm of modification of the molding plate should be made at one visit. • The alveolar segments should be directed to its final and optimal position. • Care must be taken to prevent the soft denture material from building up on the height of the alveolar crest as this will prevent complete seating of the molding plate. Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
  • 92. Incorporation of Nasal Stent • The nasal stent component of the NAM appliance is incorporated when the width of the alveolar gap is reduced to about 6 mm. • The rationale for delaying addition of the nasal stent is that as the alveolar gap is reduced, the base of the nose and the lip segment alignment is also improved. • The alar rim, which at birth was stretched over a wide alveolar cleft deformity, will show some laxity as the cleft segments are brought together. • Once the alar base on the cleft side shows less stretch and tension, it can be elevated into symmetrical and convex form with the nasal stent and not be subjected to additional stretch. Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
  • 93. Incorporation of Nasal Stent • When the nasal stent is introduced to a nostril that is overlying a very wide alveolar gap, it may stretch further the nostril rim and increase nostril circumference. • This may result in a postsurgical “mega-nostril” or a nostril of greater circumference on the cleft side than the noncleft side. • The nasal stent is made of 0.36 inch round stainless steel wire and takes the shape of a “Swan Neck”. Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
  • 94. Incorporation of Nasal Stent • The stent is attached to the labial flange of the molding plate, near the base of the retention arm. • It extends forward and then curves backwards (in the form of a swan neck) entering 3–4 mm past the nostril aperture. • As the wire extends into the nostril, it is curved back on itself to create a small loop for retention of the intranasal portion of the nasal stent. • The hard acrylic component is shaped into a bi-lobed form that resembles a kidney Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
  • 95. Incorporation of Nasal Stent • The upper lobe enters the nose and gently projects the dome forward until a moderate amount of tissue blanching is evident. • The lower lobe of the stent lifts the nostril apex and defines the top of the columella Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
  • 96. Nonsurgical columella lengthening in patients with bilateral cleft lip and palate • In patients with bilateral cleft lip and palate, there is a need for two retention arms as well as two nasal stents, which are similar in shape to the unilateral stent. • The initial goal of molding is to center the premaxilla, retract the premaxilla and reduce the bilateral cleft gaps to 5–6 mm prior to adding the nasal stents Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
  • 97. • The first goal of PNAM in bilateral cases is to move the premaxillary segment posteriorly and medially, while preparing the lateral alveolar clefts to come in contact with the premaxilla. • The posterior lateral palatal shelves are molded to the appropriate width to accept the premaxilla. The premaxilla is retracted and derotated as necessary using the molding plate in conjunction with external tape and elastics.
  • 98. Nonsurgical columella lengthening in patients with bilateral cleft lip and palate • A horizontal band (columella band) of denture material is added to join the left and right lower lobes of the nasal stent, spanning the columella. • The inferior surface of the columella band sits at the nasolabial junction and helps to define this angle. • The superior surface of the columella band presses up against the nostril apex, located at the top of the columella. Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
  • 99. Nonsurgical columella lengthening in patients with bilateral cleft lip and palate • Tape is adhered to the prolabium underneath the horizontal lip tape and stretches downward to engage the retention arm with elastics . • This vertical pull provides a counter stretch to the upward force applied to the left and right nostril apex of the columella band. • Taping downwards on the prolabium helps to lengthen the columella and vertically lengthens the often small prolabium. Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
  • 100. Primary surgical repair of the alveolus lip and nose • The alignment of alveolar segments and premaxilla, correction of nasal asymmetry, elongation of the columella and projection of the nasal tip are accomplished before the primary surgical repair. • Surgical closure of the lip and nose is performed from 3 to 4 months of age. • Achievement of presurgical clinical objectives in patients with bilateral cleft lip and palate tends to take 1–2 additional months. Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
  • 101. Primary surgical repair of the alveolus lip and nose • The surgical technique must be modified to take advantage of the NAM preparation. • Approximation of the alveolar segments permits the surgeon to perform gingivoperiosteoplasty. • Reshaping of the deformed alar cartilage and stretching of the nasal mucosa enhances the surgeons ability to achieve a good primary rhinoplasty and surgical alveolar repair. Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
  • 102. Complications • Most common problems: irritation to the oral mucosa, gingival tissue, or nasal mucosa. • Intraoral tissues may ulcerate from excessive pressure applied by the appliance. • The intranasal lining of the nasal tip can become inflamed if too much force is applied by the upper lobe of the nasal stent. • Skin irritation because of the tape. Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261-267). Elsevier.
  • 103. Disadvantages of PNAM Maxillary growth restriction Negative influences on speech because of delayed palate closure The costs of the treatment Complexity of treatment Lip surgery alone has the same effect as that of PSIO The therapeutic implication of presurgical orthopedics is not growth guidance but repositioning of the maxillary segments (Kriens, 1989). Opponents of the approach also state that PSIO is ineffective and unnecessary (Subtelny, 1964; Pruzansky and Aduss, 1964; Berkowitz, 1990). (Pruzansky and Aduss, 1964; Huddart and Bodenham, 1972; Ross, 1987; Kramer et al. 1992; Prahl et al., 2001).
  • 105. Long Term Effects of PSIO
  • 106. Facial growth, maxillary arch, and dentition and occlusion Proponent • Mishima et al.,using a two-group quasirandomised design with a control group (n = 8) children without PSIO, found that prior to lip surgery the maxillary segments in the PSIO group (n = 12) moved towards the midline, and in the non-PSIO group, the maxillary segments remained in the same position or displaced laterally. At 18 months of age, the curvature of palatal shelves was less steep, and there was less arch collapse in PSIO group when compared with control group. At 4-years of age, the distance between deciduous canines and second deciduous molars was larger in the PSIO group; other variables did not differ between the two groups. Opponent • Lee et al. assessed the effects of NAM and gingivoperiosteoplasty (GPP) in 20 UCLP patients at 6-year and at 11.5- year that is, at pre-pubertal age using lateral cephalogram and found that midface growth in sagittal or vertical planes (up to the age of 9-13 years) was not affected by pre-surgical alveolar moulding and GPP. Niranjane, P.P., Kamble, R.H., Diagavane, S.P., Shrivastav, S.S., Batra, P., Vasudevan, S.D. and Patil, P., 2014. Current status of presurgical infant orthopaedic treatment for cleft lip and palate patients: A critical review. Indian Journal of Plastic Surgery: Official Publication of the Association of Plastic Surgeons of India, 47(3), p.293.
  • 107. Nasal symmetry and nasolabial appearance Proponent • In a 6-year follow-up by Bennun et al. to compare growth and cosmetic results of 97 UCLP patients using plaster models by using surface impressions of the babies revealed a better and permanent nostril symmetry, increase in the columellar length and no alar cartilage luxation in patients who had the nasal component. • A 9-year follow-up by Barillas et al. using stone cast measurements in 25 UCLP patients revealed that the nasal symmetry was improved by PNAM and was maintained at 9-year. Opponent • Sulaiman et al. did a 15-year follow-up of pre-surgical orthopaedics, followed by primary correction for unilateral cleft lip nose and found that the nostril height and width ratio and the height of the alar groove were significantly improved post-operatively and maintained for 15-years, but also stated that repositioning of nasal cartilage at infancy might not eliminate need for secondary correction after puberty. Niranjane, P.P., Kamble, R.H., Diagavane, S.P., Shrivastav, S.S., Batra, P., Vasudevan, S.D. and Patil, P., 2014. Current status of presurgical infant orthopaedic treatment for cleft lip and palate patients: A critical review. Indian Journal of Plastic Surgery: Official Publication of the Association of Plastic Surgeons of India, 47(3), p.293.
  • 108. Speech Proponent • Suzuki et al. studied the effect of pre- operative orthopaedic plate on articulatory function in 17 CLP children. Speech was assessed by speech therapists 3-year 11 months after palatoplasty. The results indicated that the continuous use of orthopaedic plate was effective in preventing palatalized articulation. Opponent • Konst et al. evaluated language skills of children between the ages of 2 and 6-year. The results showed that the early positive effects of PSIO changed over time, and no differences were found in language development between the two groups at the age of 6-years. Niranjane, P.P., Kamble, R.H., Diagavane, S.P., Shrivastav, S.S., Batra, P., Vasudevan, S.D. and Patil, P., 2014. Current status of presurgical infant orthopaedic treatment for cleft lip and palate patients: A critical review. Indian Journal of Plastic Surgery: Official Publication of the Association of Plastic Surgeons of India, 47(3), p.293.
  • 109. • Liou et al. reported that nasal asymmetry was significantly improved after nasoalveolar molding in infants with cleft lip and palate; but after the primary closure of the cleft lip and nose, there was a significant relapse of the nasal asymmetry in the first year postsurgery, which remained stable afterwards. This relapse was the result of a significant differential growth between cleft and noncleft sides in the first year postsurgery. • Pai et al., who used the nasoalveolar molding (NAM) appliance in their study, concluded that there was some relapse of nostril shape in width (10%), height (20%), and angle of columella (4.7%) at 1 year of age, compared to their presurgical status. • Papadopoulos et al. also investigated the effectiveness of presurgical infant orthopedics using a systematic review. They showed that there were no significant differences in craniofacial and dentoalveolar changes, indicating that PSIO treatment had no effect on cleft lip and palate patients. 3) Esenlik E. Presurgical Infant Orthopedics for Cleft Lip and Palate: A Review. Journal of Surgery [Jurnalul de chirurgie] 2015; 11(1): 9-14. doi:10.7438/1584-9341-11-1-2
  • 110. Proponents of PNAM • Aids in the surgical repair of the lip and palate by reducing defect width of the palatal and alveolar ridge, which in turn will reduce lip tension and benefits wound healing postoperatively • Prevents initial collapse after surgery and crossbites • Achieves symmetrical arch form • Improves position of alar base • Less extensive orthodontic treatment at later ages Surgery • Improved growth of the maxilla as repositioning of the bony segments will help in future growth and development • Reduced tongue interference with the palatal shelves may encourage the normal growth of the palatal shelves, thus allowing spontaneous reduction in the width of the cleft Growth • Improved speech development due to improved physiological tongue function and position (prevents twisting and dorsal position of the tongue in the cleft). • The improvement was significant in children aged 1–3 years; this was seen as the ability of the child to produce longer sentences. However, this improvement diminished in children aged 6 years • Improved feeding (less danger of aspiration); however, there is no evidence to support this • Better nose breathing and decreased nasal regurgitation • A positive psychological effect on the parents Function Alzain, I., Batwa, W., Cash, A. and Murshid, Z.A., 2017. Presurgical cleft lip and palate orthopedics: an overview. Clinical, cosmetic and investigational dentistry, 9, p.53.
  • 111. Opponents of PNAM • Neonatal maxillary orthopedics is a complex and expensive therapy that is ineffective and unnecessary because parents are obliged to travel frequently to the treatment center and endure an increased burden of care. • There is no significant improvement in parents’ satisfaction. • The overall cost of treatment is significantly high. Cost- Effectiveness •Neonatal maxillary orthopedics restricts maxillary development as a result of the molding process •There are no apparent long-term effects on facial growth in either vertical or anteroposterior dimensions. •However, there is some evidence emerging that those patients who have had NAM do have improved nasal anatomy. Growth • Influences speech negatively due to delayed surgery of the hard palate. • It is not necessary for feeding or orthodontic reasons,did not improve feeding efficiency or general body growth,and did not improve deviated swallowing characteristics. Function Alzain, I., Batwa, W., Cash, A. and Murshid, Z.A., 2017. Presurgical cleft lip and palate orthopedics: an overview. Clinical, cosmetic and investigational dentistry, 9, p.53.
  • 112. A newer classification system (Daigavane P S, Hazarey PV, Niranjane P, Vasudevan SD, Thombare BR, Daigavane S. A New Classification System for Unilateral Cleft Lip and Palate Infants to assist Presurgical Infant Orthopedics. The Journal of Clinical Pediatric Dentistry . Volume 39, Number 3/2015) Type Model Features Treatment Plan Type A Greater and lesser segment are of sufficient length 1. Well expanded tuberosities are used for support. 2. Soft liner is placed on the anterior 1/3rd 3. Equal amount of the acrylic is removed from the opposite side of the segment to make space for the alveolar segment to move. Type B Greater segment is of sufficient length but lesser segment is small and/or placed posteriorly 1. Only the greater segment is molded into an arch form. 2. An attempt to achieve complete closure of the alveolar segments may lead to arch constriction. 3. Alveolar Bone Grafting can be done later. Type C Greater and lesser segments are of small length and parallel to each other 1. Transverse width of the arch will be maintained using permasoft. 2. No attempt must be made to close the alveolar defect. 3. Later closure can be done with flap, or the defect can be sealed with an obturator modified with denture. Type D Greater segment is overlapping the lesser segment 1. The “Locked Segments” commonly seen in cases with cleft lip and alveolus. 2. Consideration should be given to only nasal molding. 3. Transverse growth of the maxilla will unlock the overlapping to attain arch uniformity.
  • 113. Pre-directional appliance: A new approach to correct shifted premaxilla in bilateral cleft cases Daigavane, P.S., Hazarey, P., Vasant, R. and Thombare, R., 2011. Pre- directional appliance: A new approach to correct shifted premaxilla in bilateral cleft cases. Journal of Indian Society of Pedodontics and Preventive Dentistry, 29(6), p.39.
  • 114. Introduction • Management of bilateral cleft lip and palate cases is a challenging task, and if the premaxilla is shifted to either side, it poses a problem for the surgeon to operate and also for the orthodontist to do the orthodontic alignment. • The aim of this study was to reposition the shifted premaxilla for better retraction with presurgical infant orthopedics, thus reducing the tissue tension and further scarring which have detrimental effects on maxillary growth. • The innovative technique with pre-directional (PD) appliance is easy to fabricate and use and works in this direction.
  • 116. Method of Fabrication • Pre-directional (PD) appliance, fabricated in heat-cure resin, is a modification of Grayson's presurgical naso alveolar molding (PNAM) appliance. • To make the anterior segment flexible, the appliance was modified by marking two parallel vertical lines and a transverse cut was given in the anterior segment of the appliance to separate it from the posterior segment. • 1 mm acrylic was reduced from edges of both the segments.
  • 117. • With the straight fissure bur, cuts were made on the vertical lines. • Both these segments were repositioned on the cast; two 8-mm NITI coil springs were placed in the vertical cuts and rejoined with self-cure resin.
  • 118. • Permasoft was applied on the inner surface of the anterior segment on the right side to push the premaxilla to left side, and also, on the medial aspect of the posterior alveolar segment for expansion. • The appliance was retained with tapes (3M micropore surgi tape) and red elastics. • The elastic force on both sides differed; on the right side it was kept inactive for appliance stability, while on the left side it was stretched double its diameter, exerting a force of 6 ounces on the premaxilla. The patient was evaluated weekly for correction.
  • 119. Results • On evaluation after 2 months 20 days, the premaxilla was shifted to the left side by 5.5 mm, the premaxilla and prolabium were positioned in the middle, facial symmetry was observed with both the nostrils equally visible
  • 120. • .At this stage, the PD appliance was replaced by Grayson's PNAM appliance. Nasal stents were added for molding. • For prolabium lengthening, a vertical tape was overlapped on two red elastics (knotted with eachother) placed on retentive buttons. • During suckling, stent forces the nose dome upward and forward, while the lip tape forces the prolabium downward, thus lengthening the columella.
  • 121. • It was observed that after 2½ months, the premaxilla was retracted 4.5 mm uniformly with successful nasal molding. • At 6½-7 months of age, both side lips were operated in the same operative session with Millard and Nordoff technique. • On evaluation, at the age of 1 year 3 months, it was observed that facial symmetry, columellar lengthening, and nasal molding were maintained.
  • 122. • As this appliance could reposition the premaxilla within short duration, it was possible to do nasal molding utilizing the elasticity of the nasal cartilage. • Alveolar segments were expanded to 1.5 mm, premaxilla was retracted symmetrically by 4.5 mm, facial esthetic was improved, prolabium was lengthened to 6 mm, no tissue tension was observed during surgery and satisfactory lip repair was accomplished in one stage
  • 123. Advantages • Inexpensive • Easy to fabricate • Does not require complicated laboratory procedures • Gives quick results • The rate of bone healing is inversely proportional to size of defect; thus, presurgical orthopedics favors bone formation.
  • 124. Conclusion • Treatment outcomes, and favorable or unfavorable maxillary growth, may be anticipated according to initial severity of the cleft deformity and less related to the given treatment. • More importantly, because there is a demonstrated variation in severity of cleft deformity, treatment protocol could vary according to severity of the initial deformity and children with CLP could be sorted by severity before correlating specific treatment variables with outcomes.
  • 125. Bibliography • Murray, J.C., 2002. Gene/environment causes of cleft lip and/or palate. Clinical genetics, 61(4), pp.248-256. • Murthy P S, Deshmukh S, Bhagyalakshmi A, Srilatha K T. Pre Surgical Nasoalveolar Molding: Changing Paradigms in Early Cleft Lip and Palate Rehabilitation. J Int Oral Health 2013; 5(2):76-86. • Contemporary Orthodontics: William R. Profitt (5th edition) • Shetye, P.R. and Grayson, B.H., 2017, September. NasoAlveolar molding treatment protocol in patients with cleft lip and palate. In Seminars in Orthodontics (Vol. 23, No. 3, pp. 261- 267). Elsevier. • Grayson, B.H. and Cutting, C.B., 2001. Presurgical nasoalveolar orthopedic molding in primary correction of the nose, lip, and alveolus of infants born with unilateral and bilateral clefts. The Cleft palate-craniofacial journal, 38(3), pp.193-198. • Niranjane, P.P., Kamble, R.H., Diagavane, S.P., Shrivastav, S.S., Batra, P., Vasudevan, S.D. and Patil, P., 2014. Current status of presurgical infant orthopaedic treatment for cleft lip and palate patients: A critical review. Indian Journal of Plastic Surgery: Official Publication of the Association of Plastic Surgeons of India, 47(3), p.293.
  • 126. • Singla, S. and Kaur, M., 2008. Cleft palate habilitation. The Indian Journal of Pediatrics, 75(7), pp.703-708. • Kalaskar, R., Kalaskar, A., Naqvi, F.S., Tawani, G.S. and Walke, D.R., 2013. Prevalence and evaluation of environmental risk factors associated with cleft lip and palate in a central Indian population. Pediatric dentistry, 35(3), pp.279-283. • Textbook of Oral and Maxillofacial Surgery – Neelima Anil Malik (3rd edition) (Daigavane P S, Hazarey PV, Niranjane P, Vasudevan SD, Thombare BR, Daigavane S. A New Classification System for Unilateral Cleft Lip and Palate Infants to assist Presurgical Infant Orthopedics. The Journal of Clinical Pediatric Dentistry . Volume 39, Number 3/2015)

Editor's Notes

  1. Oral Clefts are usually classified on the basis of anatomy and embryology. Each category can be subdivided into complete and incomplete, unilateral and bilateral clefts.
  2. This classification had anatomical basis
  3. Kernahan classification is simplified by representing various clefts in the form of a Y. The anterior portions of the Y depict the lip (1 & 4), the middle alveolus (2 & 5), incisive foramina and the posterior portion (the area of the hard palate)from the alveolus back to the incisive foramen (3 & 6), posterior to the hard palate (7 & 8), and the soft palate (9). This facilitates charting of the deformity by residents in a cleft lip and palate clinic.
  4. Based on embryological principle
  5. Velopharyngeal mechanism: The hard palate provides the partition between oral and nasal cavities and soft palate functions with the pharynx in an important valve action, referred to as velopharyngeal mechanism. In normal speech, this valve action is intermittent, rapid and variable to effect normal sounds and pressures by deflecting the air stream with its sound waves out of the mouth. Without this valve action, speech is hypernasal and deglutition is impaired. Psychological and Growth problems.
  6. Velopharyngeal mechanism: The hard palate provides the partition between oral and nasal cavities and soft palate functions with the pharynx in an important valve action, referred to as velopharyngeal mechanism. In normal speech, this valve action is intermittent, rapid and variable to effect normal sounds and pressures by deflecting the air stream with its sound waves out of the mouth. Without this valve action, speech is hypernasal and deglutition is impaired. Psychological and Growth problems.
  7. In this study, type and timing of treatment was evaluated at six centers and that will be identified by a letter, A- F. The measures, adopted in this study to assess outcomes of craniofacial form (cephalometry), dental arch relationships (Goslon Yardstick), and nasolabial appearance, represent a modest beginning for this type of research. Centers B and E ranked best in the group comparison, and with equally good results. At both centers, conventional surgery is performed by a few surgeons, but with some differences of technique and timing . common features in both centers were use of a single-layer cranially- based vomer flap to close the anterior palate at the time of lip repair. Center A - the treatment methods differed from those at centers B and E in that they practiced passive preoperative jaw orthopedics and delayed closure of the hard palate until the age of 9 years and this more demanding and expensive program gave no demonstrable advantages in terms of dental arch relationships and cranio­facial morphology. At center C and D, ranked lowest for dental arch relationships and craniofacial form, active preoperative jaw orthopedic treat­ment including extra oral strapping was carried out in all cases ,many surgeons had been involved in the treatments. The children at center F also underwent active orthopedics including nostril traction and had undergone primary bone grafting to the cleft in the alveolar process There are grounds for supposing, therefore, that the early bone grafting and orthopedics is responsible, at least in part, for this group's lower ranking The centers differed in the amount of secondary surgery that had been performed, with the highest level performed at center D, the lowest ranked center. Analysis of the numbers of secondary operations also revealed differences in approach between the centers, particularly with regard to center B, where the policy of no secondary lip and nasal revisions until the teens pertained. So this evaluation shows that timing and type of surgery plays an important role in success of treatmnet.
  8. before 2006 centers in the US and Canada had not been as successful as those in Europe in establishing interest and commitment to inter-center collaborative outcome studies.
  9. Pre-Surgical Infant Orthopaedics has been employed since 1950 as an adjunctive neonatal therapy for the correction of cleft lip and palate. Most of these therapies did not address deformity of the nasal cartilage in unilateral and bilateral cleft lip and palate, as well as deficiency of the columella tissue in infants with bilateral clefts.
  10. After the maxillary appliance has the segments in good alignment, the plastic surgeon restores lip continuity. The molding pressure of the surgically closed cleft lip, along with the appliance helps to create an ideal arch form.
  11. Positive psychological effect on the parents
  12. 1790- A similar technique was shown by Desault to retract the maxilla before surgical repair in patients with bilateral cleft repair. 1844- Esmarch and Kowalzig used a bonnet and strapping to stabilize the premaxilla after surgical retraction. 1927- to approximate the ends of the alveolus before lip repair. All procedures, which at the time were mainly performed by orthodontists or by the surgeons, were based on the ever proven assumption that a narrow and well aligned cleft would be easier to repair, with less undermining and less mobilization of soft tissues.
  13. 1950- He used a series of plates to actively mold the alveolar segments into the desired position. Burston, an orthodontist, further developed McNeil’s technique and made it popular. 1993- The original research on neonatal molding of the nasal cartilage was performed by Matsuo using silicon tubes to mold the nostril.
  14. During this passive orthopedic procedure, the alveolar clefts were corrected without correcting the nasolabial deformities, and the retraction of the premaxilla was very limited and couldn't effectively close the cleft.
  15. From Mc Neil’s concept of alveolar molding to concept of nasoalveolar molding many changes have taken place in appliance designs. These appliances could be classified as Active appliances move alveolar cleft segments in a predetermined manner with controlled forces whereas passive appliances deliver no force but act as a fulcrum upon which forces created by surgical lip closure, contour and mold the alveolar segments in predictable fashion.
  16. The construction of these appliances starts by creating an intraoral impression of the cleft infant and then pouring this impression into the plaster. Either the model is then sectioned and the acrylic mouth plate made on the adjusted plaster cast or a spring may be added to the plate to direct the alveolar processes to adapt a position where more normal maxillary arch form would be achieved
  17. Passive appliances are slightly different from active appliances. They are constructed on the poured study model and fit directly onto the alveolar processes. The clinician at the chairside may add flowable acrylic or remove acrylic in a process called negative sculpting. This alteration in the shape of the fit surface of the appliance will allow the alveolar processes to grow passively as planned by the clinicianFi g ure 6 Passive appliance. Notes: No need to move the smaller alveolar segment laterally; there is enough space for larger segment to mold. ( A ) The two alveolar segments are not aligned as shown by the red doted lines. ( B ) An acrylic appliance was placed (shaded area) and as a result of molding the greater alveolar segment was moved towards the lesser one. The green arrow shows the direction of movement of the segments. Note that the lesser segment did not move. ( C ) The two segments after alignment.
  18. This treatment modality includes as its objectives the active moulding and repositioning of the deformed nasal cartilages and alveolar processes, as well as the lengthening of the deficient columella.
  19. The original research on neonatal molding of nasal cartilage was performed by Matsuousing silicon tubes to mold the nostril.
  20. Matsuo applied this concept for the correction of nasal deformities in cleft lip patients. It is on this principle that the concept of nasoalveolar molding works. It is also suggested that nasolaveolar molding stimulated immature nasal chondroblasts, producing an interstitial expansion that is associated with improvement in the nasal morphology (Chondral Modeling hypothesis, Hamrick 1999)
  21. It has been suggested by Skoog that repair of the cleft lip is incomplete without the simultaneous reconstruction of bone defect of the maxilla by gingivoperioplasty, as there will be risk of collapse of the lateral segments of the maxilla due to the pressure exerted by the repaired lip. Furthermore it is suggested that it coordinates the growth at the growth centers as the maxillary discontinuity is restored. However, controversies exist regarding the conduct of gingivoperioplasty in cleft patients because of its potential to impair maxillary growth. It is important to recognize that the state of art of gingivoperioplasty has changed since the time of its introduction by Skoog in 1967.
  22. In the treatment of cleft lip nasal deformity, the correction of nose continues to be the greatest challenge. In patients with unilateral cleft lip/ palate, the nasolabial defect influences the physical appearance of the child. Hence it is recommended to perform nasal molding prior to primary lip repair. Considering that nose is an important component of facial esthetics, correction of nasal symmetry and nasolabial fold is an important objective of nasoalveolar molding. 2) However a drawback of this stent was that it required an intact nostril floor. In the cases without nasal floor, Matsuo performed primary lip adhesion to make stenting possible.  3) This did not require the presence of intact nasal floor and as the stent was added to the plate, controlled force could be exerted. 4) The advantage of this appliance was that there was no need for nasal impressions and same appliance could be used for different patients after sterilization
  23. The objective of presurgical NAM is to reduce the severity of the original cleft deformity and thereby enable the surgeon to achieve better repair of the alveolus, lip and nose.
  24. The parents/ caregivers are asked to wait in the waiting room while the baby is taken to the clinical operatory for the impression procedure. The intention of having the caregivers out of the clinical operatory during the impression procedure is to remove any distraction from the treatment team should an airway emergency occur.
  25. Mother sitting erect,Child at an angulations of 60-70° in her lap in SUPINE POSITION. Position of the operator Just behind the infant with one hand supporting the head . Gloves are never used coz it increases the setting time
  26. 1) All the undercuts and the cleft space are blocked with wax. 2) The borders are trimmed to remove sharp edges and points. 3) The borders in the place of the frenum and other attachments must be adequately relived.
  27. 1) The exact location of the retention arm is determined at the chair side. It is positioned so as not to interfere with bringing the cleft lips together. 4) The nasal stent is not fabricated at this time. Instead its construction is delayed until the cleft gap between the alveolar segments is reduced to about 5–6 mm in width.
  28. The molding plate is checked for over extension especially in the area of the vestibular folds as well as along the posterior border. Check for any sharp edges or rough surfaces that may irritate the soft tissue. 1) The horizontal surgical tapes are quarter inch in width and about 3–4 inches in length. 3) The amount of force could vary depending on clinical objective and the mucosal tolerance to ulceration. The angle of these tapes vary according to the palatal plane angle but should be optimized to achieve retention of the NAM appliance to the alveolar ridges and palatal shelves. Additional tapes may be necessary to secure the horizontal tape to the cheeks. Parents are instructed to keep the plate in the mouth full time and to remove it for daily cleaning.
  29. The baby is seen weekly to make adjustments to the molding plate to bring the alveolar segments together. In centers where the families live a great distance from the treatment center, adjustments may take place every 2 weeks.
  30. To appreciate the correct shape and orientation of the wire stent one can use a roll of soft wax and make a template seated on the molding plate.
  31. . A layer of soft denture liner is added to the hard acrylic for comfort.
  32. 1) After adding the nasal stents in bilateral cleft treatment, the attention is focused on nonsurgical lengthening of the columella. To achieve this objective, 3) The columella band is gradually augmented at the superior and inferior surfaces, thus elongating the columella tissue. During this phase of adjustments to the columella band the nasal tip continues to be projected forward by augmentations to the upper lobes of the nasal stents
  33. The horizontal lip tape is added after the prolabium tape is in place.
  34. The duration of molding therapy could also vary depending on the severity of the initial cleft deformity.
  35. 2) These are commonly found in the oral vestibule and on the labial side of the premaxilla. The oral and the nasal cavities of the infant should be carefully examined on each visit for ulceration and appropriate adjustments should be made to the molding plate to relieve sore spots.
  36. the permanence of the improvement in nasal symmetry and appearance using PNAM remains controversial
  37. Suggested advantages of presurgical orthopedic treatment
  38. Rehabilitation of a Cleft infant induces various thoughts regarding growth and development. No cleft child has similar alveolar morphology and anatomy, thus the mechanics in the alveolar molding technique also varies. The classification takes into consideration: Age of infant Length of the lesser and greater segment Position of the segments in relation to each other Position of tuberosity Amount of defect
  39. A male infant of 20days was seen with complete bilateral cleft lip and palate, with premaxilla shifted to right [Figure 1]a-c. After complete evaluation by Cleft Team, it was decided to reposition the premaxilla.
  40. This case report shows the use of PD appliance which was fabricated to treat the shifted premaxilla, with the help of anterior segment made flexible by NITI springs.
  41. Presurgical orthopedics with PD appliance is worth in infants with shifted premaxilla in bilateral clefts