Various Indices to assess treatment outcome of Palatoplasty and Chieloplasty

1. Anas Imran Arshad, Mohammad Khrusheed Alam,
Mohd. Fadhli Khamis
ASSESSMENT OF POST-TREATMENT OUTCOME
OF PAKISTANI CHILDREN HAVING TOTAL
UNILATERAL CLEFT LIP AND PALATE USING
EUROCRAN INDEX

2. INTRODUCTION
• Cleft lip and palate (CLP) is defined as “non-fusion of the upper
lip and/or the roof of the mouth (hard and/or soft palate) which
appears as a gap in the affected structures” (Erverdi and Motro,
2015).

3. EMBRYOLOGICAL CLASSIFICATION
A
D
B
C
(Millard Jr, 1976)

4. EPIDEMIOLOGY
• Unilateral Cleft Lip and Palate (UCLP) is one of the most
common congenital orofacial defects. (Murray, 1995)
• With an incidence of 1.91 per 1000 live births (Elahi et al.,
2004), cleft lip and palate is the second most
common birth defect behind cardiac defects. (Quereshy et al.,
2012)

5. ETIOLOGY
Rubella Infections,
Vitamin A Excess,
Folate metabolism,
Valium, Aspirin, etc.
(Dixon, Trainor, & Dixon, 2007)
Genetic factors Environmental
factors

6. WORKFLOW OF MANAGEMENT
Pre-natal Period
Paedodontist and
Orthodontist for dental
anomalies
Maxillofacial Surgeons
and plastic surgeons for
surgical consult
Prosthodontist for early
provision of obturators
Genetics expert for parent
counselling and pregnancy
planning
Neo-natal period 2 weeks- 6 months
NAM appliance for pre-surgical infant orthopaedics Primary surgical repair of lip and palate
Deciduous dentition 2- 7 years
Psychological consult, speech therapies and velopharyngeal repair Considerations for revision surgeries
Mixed dentition 7- 12 years
Combined efforts of orthodontist
and maxillofacial surgeon
Plan pre-surgical maxillary expansion
and secondary alveolar bone grafting
Planning of orthopaedic appliance
for maxillary growth modification
Permanent dentition 12 years to adult
Psychological motivation, speech therapies Considerations for orthognathic surgeries and nasolabial revisions

7. LIP REPAIR TECHNIQUES
Tennison-Randall Technique
(Tennison, 1952; Randall,
1959)
Millard with rotation
advancement technique

8. PALATAL REPAIR TECHNIQUES
Bardach Technique
Von Langenbeck V-Y Pushback Bardach two-flap

9. OUTCOME INDICES
Outcome indices assess the quality of CLP treatment provided.
There are various methods to assess the cleft outcomes, one of
the most popular method is dental arch relationships
assessment.
There are many indices which assess dental arch relationships
like, GOSLON, modified Huddart/Bodenham, and EUROCRAN.

10. Sk. Class I or II
Both centrals positive
Overjet and Overbite
Grade 1(a)
(b) No Overjet and
Overbite
EUROCRAN index ( Based on Dental)

11. Sk. Class I
Grade 2
Non
Cleft
Side
Cleft
Side
Grade 3
Mild Sk. Class III
Edge to Edge
Grade 4(a)
(b)
Sk. Class III
One or both side anterior
crossbite
One or both side anterior
crossbite. Central incisor
may or may not touch
lowers

12. Good Anterior and
Posterior Palatal Height
with minor surface
irregularities
Grade 1
Grade 2
Moderate anterior and
posterior Palatal Height
with moderate surface
irregularities
Grade 3
Severe defect in height with
gross surface irregularities with
hour-glass like arch
constriction
EUROCRAN index ( Palatal Morphology)

13. BACKGROUND OF STUDY
• In Pakistan, one child in every 523 livebirths suffers from some
form of clefting.
• Treatment outcome of any type of CLP in Pakistani population
has never been documented.
• There is a lack of knowledge regarding the treatment outcome
in Pakistani population.

14. JUSTIFICATION OF STUDY
• Facilitate decision making and modification of treatment
planning. (Orthognathic & Surgical modalities)
• Form a database for future comparative studies.
• Reduce treatment cost.

15. GENERAL OBJECTIVES
• To determine the treatment outcome based on Dental Arch
Relationships in Pakistani Non-Syndromic Total Unilateral Cleft
Lip and Palate patients (TUCLP) using EUROCRAN index

16. SPECIFIC OBJECTIVES
• To determine the distribution of favorable/unfavorable treatment
outcome by using the EUROCRAN yardstick.
• To evaluate the association of the pre-natal (sex, family history
of cleft, and side of cleft) and post-natal treatment factors
(cheiloplasty and palatoplasty) with the treatment outcome.

17. RESEARCH QUESTION
• What is the prevalence of favorable and unfavorable treatment
outcome among Pakistani population?
• Is there an association among the pre & post-natal factors and
treatment outcome (dependent variable)?

18. NULL HYPOTHESES
• There is no association among the pre & post-natal factors and
treatment outcome.

19. METHODOLOGY
Ethical Approval was obtained from Human Research Ethics
Committee (USM/JEPeM/15050166)
Study Design
• It is a retrospective observational analytical study.
Source population
• Pakistani non-syndromic children having total unilateral cleft lip
and palate
Sampling method
• Collection of dental models from archives

20. SAMPLE SIZE CALCULATION
• Sample size was calculated using following formula (Lwanga
and Lemeshow, 1991);
• n = ﴾Z/d)²×P(1-P)
• required sample size, n
• level of confidence, Z = 1.96 (level of significance = 0.05)
• Absolute precision, d = 0.09 (9%)
• P is estimated proportion of individuals in the sample with the characteristic of interest, P=0.317
(Alam et al., 2008; Zreaqat et al., 2009)
• Therefore, the required sample size (n) was 102.

21. No Alveolar Bone
Graft (ABGs) or
Ortho
Non Syndromic TUCLP patients
7-10 years
of age
Primary lip and palate
repair has been done
Subjects with other types of CLP
defects
EXCLUSION
CRITERIA
INCLUSION
CRITERIA
Incomplete or Syndromic Clefts
(Dugas, 2010)

22. DATA COLLECTION
101 pairs of Dental
models were
collected from
archives
1
Conduction of
calibration courses
for observing
individuals
2
Single blinding by
random number
allotment to each
dental model
3
Statistical analysis
and interpretation
using SPSS 22.0
6
2-week interval
between instances
to eliminate
memory bias
5
Five observers
graded the models
at two instances
4

23. RESEARCH TOOLS

24. STATISTICAL ANALYSES
Inter & Intra Examiner Agreement
Correlation of dependent
variables and outcome
Association of variables that
affect outcome
Exploratory
Analysis to assess
predictability of
variable
Kappa Statistics
Chi-Square
Crude Logistic
Regression
Backward Logistic
Regression

25. RESULTS
• Kappa values between the first and second instance of
observations for dental grading by each examiner ranged from
0.606-0.778 that show good intra-examiner agreement
• Kappa values for the agreement of observations for palatal
morphology grading between both examiners were 0.574-0.969,
that show moderate to very good inter-examiner agreement

26. GRADING BASED ON EUROCRAN
19
42
40
Excellent Fair Poor
Palatal morphology
6
29
53
13
Excellent Good Fair Poor
Dental grading
Mean score ± SD = 2.72±0.76 Mean score ± SD = 2.20±0.73

27. VARIABLE DICHOTOMIZATION
6
29
53
13
Excellent Good Fair Poor
35
66
Favorable Unfavorable
(Chan et al., 2003) (Alam et al., 2008)

28. CHARACTERISTIC DISTRIBUTION
24
11 13
22 22
13
29
6
30
5
34 32
17
49
44
22
36
30
40
26
Male Female Yes No Left Right Millard Mod.
Millard
VL VY
Gender Family history Cleft Side Cheiloplasty Palatoplasty
Favorable Unfavorable
Frequency
in
numbers
P-Value .099 .233 .702 .005** .009**
BASED ON DENTAL GRADING

29. 9 10
6
13
15
4
10 9
14
5
25
17
13
29 28
14
28
14
33
9
24
16
11
29
23
17
27
13
23
17
Male Female Yes No Left Right Millard Mod.
Millard
VL VY
Gender Family history Cleft Side Cheiloplasty Palatoplasty
1 2 3
CHARACTERISTIC DISTRIBUTION
Frequency
in
numbers
P-Value .263 .616 .925 .106 .494
BASED ON PALATAL MORPHOLOGY

30. UNADJUSTED LOGISTIC REGRESSION
Variables Crude ORa 95% CIb p-value
Gender
Male 1.00
Female 1.743 .649, 4.679 .270
Family history
of cleft
Yes 1.00
No 2.525 .907, 7.028 .076*
Side of Cleft
Left 1.00
Right .838 .305, 2.297 .731
Cheiloplasty
Millard 1.00
Modified Millard 4.468 1.510, 13.216 .007**
Palatoplasty
Von Langenbeck 1.00
VY pushback 3.468 1.114, 10.797 .032**
a. Crude odds ratio
b. Confidence Interval set at 95%

31. ADJUSTED: BACKWARD STEPWISE
Variables Adjusted ORa 95% CIb p-value
Family History
of Cleft
Yes 1
No 2.374 .872, 6.462 .091
Cheiloplasty
Millard 1
Modified Millard 4.518 1.533, 13.313 .006**
Palatoplasty
Von Langenbeck 1
VY pushback 3.666 1.203, 11.175 .022**
a. Crude odds ratio
b. Confidence Interval set at 95%
Five variables were entered at Step 1

32. DISCUSSION
• Here we assessed 101 cases of total unilateral cleft
phenotype only, which is in comparison the largest
sample size for single cleft phenotype.
• We found a significant association of two post-natal
factors (cheiloplasty and palatoplasty) with the
treatment outcome.

33. DISCUSSION
STUDY POPULATION NUMBER MEAN (SD) REFERENCE
DUTCH 97 1.97 (0.88) (Fudalej et al., 2011)
SWISS 33 2.50 (1.2) (Mueller et al., 2012)
POLISH 61 2.58 (0.92) (Fudalej et al., 2011)
PAKISTAN 101 2.72 (0.76) CURRENT STUDY
BASED ON DENTAL GRADING

34. DISCUSSION
STUDY POPULATION NUMBER MEAN (SD) REFERENCE
DUTCH 97 1.96 (0.55) (Fudalej et al., 2011)
SWISS - - (Mueller et al., 2012)
POLISH 61 1.79 (0.43) (Fudalej et al., 2011)
PAKISTAN 101 2.20 (0.73) CURRENT STUDY
BASED ON PALATAL MORPHOLOGY

35. DISCUSSION
• Association studies using other indices have been
published, however, till date the effect of prenatal and
postnatal factors using EUROCRAN index has not
assessed.
• We compare our findings with the literature available
for individual lip and palate repair techniques.
ASSOCIATION OF INDEPENDENT VARIABLES

36. DISCUSSION
• We found that Modified Millard technique had four times higher
odds of producing unfavorable results as compared to
conventional Millard technique.
• This can be attributed to the excessive tension generated as a
result of relatively tighter closure of cleft lip leading to anterior
maxillary constriction.(Farronato et al., 2014)
EFFECTS OF CHEILOPLASTY

37. DISCUSSION
Millard with rotation
advancement technique
Modified Millard
Shorter lip length
(Millard, 1968)

38. DISCUSSION
• We found that VY pushback technique had three time
higher odds of producing unfavorable results as
compared to VL technique.
EFFECTS OF PALATOPLASTY

39. DISCUSSION
Von Langenbeck
V-Y Pushback
MOBILITY
Limited
mobility
Greater
mobility
SCAR
SIZE
Minimum
scarring
Large
exposed
surface
DRAW-
BACKS
Speech
problems
(Witzel et
al., 1979)
Fistula
formation
(Krause et
al., 1976)
DEFECT
SIZE
Not
suitable for
larger
defects
Suitable for
large
defects
(Kawamoto Jr,
1979)
(Bishara and Mary
Tharp, 1977)

40. CONCLUSIONS
• Based on both modules of EUROCRAN index, this
study found a higher frequency of unfavorable
treatment outcome in TUCLP patients
• Significant associations of cheiloplasty and
palatoplasty techniques with the treatment outcome
were detected

41. LIMITATIONS OF STUDY
• The design of present study, limits the discussion to a
specific instance rather than a time period.
• Certain aspects of treatment like, surgeons’ skill, tissue
growth response, defect severity could not be
assessed in this design.
• These additions can certainly facilitate the
understanding and lead to better treatment planning.

42. FUTURE RECOMMENDATIONS
• There is a need for longitudinal assessment of CLP
from infancy to adulthood.
• Radiographic assessment and predictions can play a
significant role in treatment planning.

43. CLINICAL RELEVANCE
• We identified an evident lack of adaptation to the
recent protocols and techniques for management of
CLP patients
• The data will serve as a baseline for future
comparative studies
• Facilitate surgeons and researchers to modify
management protocols and select best techniques
available.

44. REFERENCES
Alam, M. K., Kajii, T. S., Koshikawa-Matsuno, M., Sugawara-Kato, Y., Sato, Y. & Iida, J. (2008). Multivariate analysis of
factors affecting dental arch relationships in Japanese unilateral cleft lip and palate patients at Hokkaido University
Hospital. Orthodontic Waves, 67(2), 45-53.
Bishara, S. E. & Mary Tharp, R. (1977). Effects of von Langenbeck palatoplasty on facial growth. Angle Orthodontist, 47(1),
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Chan, K. T., Hayes, C., Shusterman, S., Mulliken, J. B. & Will, L. A. (2003). The effects of active infant orthopedics on
occlusal relationships in unilateral complete cleft lip and palate. Cleft Palate-Craniofacial Journal, 40(5), 511-517.
Dugas, G. (2010). Intercenter Comparison of Treatment Outcome in Patients with Complete Unilateral and Bilateral Cleft
Lip and Palate: Analysis of Craniofacial Form, University of Toronto, Ontario, Canada. Available
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45. REFERENCES
Kawamoto Jr, H. K. (1979). Correction of major defects of the vermilion with a cross-lip vermilion flap. Plastic and
Reconstructive Surgery, 64(3), 315-318.
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46. Thank You
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