the gingival retraction ,techniques, fluid control in dentistry and branch of prosthodontics

1. Fluid control & Soft tissue management

2. Fluid control and
soft tissue
management
Soft tissue
displacement
Fluid control
Mechanical
Chemical
Non surgical
Surgical
Recent advances

3. Why do we need fluid control?
Dry and clean operating field
Access and visibility

4. Sources of moisture in clinical environment
 Saliva
• Salivary glands-parotid, submandibular, sublingual
The mean flow rate (+/- SD) of unstimulated saliva
was 0.26 +/- 0.16 ml/min and that of saliva while
chewing six different foods was 3.6 +/- 0.8 ml/min.
 Blood
Inflamed gingival tissues/Iatrogenic damage

5. Water/dental materials
Rotary instruments, triplex syringe, etchants, irrigant
solutions
On a average a high speed rotatory cutting instrument
is 30 mL per minute
Gingival crevicular fluid
0.05 to 0.20 µL per minute

6. How is moisture control
important?
i. Patient related factors
Provides comfort.
Protects from swallowing or aspirating foreign
bodies.
ii. Task/technique being performed
Dental materials are moisture sensitive, success of
adhesion and physical properties relies on a dry field.

7. iii. Operator related factors
Infection control to minimise aerosol production
Increased accessibility to operative site
Improves visibility of the working field
Less fogging of the dental mirror.
Prevents contamination.

8. Methods of fluid control
• Mechanical
• Chemical
• Others

9. Mechanical methods
• Rubber dam
• Suction devices
• High volume vacuum
• Saliva ejector
• Svedopter
• Cotton rolls

10. Rubber dam
Introduced by S C Barnum 1864
Uses
For core build up, pattern fabrication
Impression making of inlays and onlays
Removal of old restoration and caries
For cementation

11. Contraindication
Should not be used with poly-vinylsiloxane
interferes with polymerization
Patients allergic to latex

12. Advantages
 Isolate one/more teeth
 Eliminates saliva from operating site
 Retracts soft tissue

13. Disadvantages
Time consuming and patients objection
Unusual tooth shapes or positions that cause
inadequate clamp placement
 Partially erupted teeth
 Broken down teeth
 Patients suffering from asthma

14. Rubber dam set
Rubber dam
Rubber dam punch
Rubber dam clamps
Rubber dam clamp forceps
Rubber dam frame/holder

15. High volume vacuum
 Powerful suction device, use of 10mm diameter
HVE tips, and a properly functioning suction pump
set to evacuate one liter per minute of fluid
Uses
Apparatus also removes small operatory debris
Excellent lip retractor
Disadvantages
Cannot be used for impression &
cementation procedure

16. Data comparing aerosols present during air abrasion cutting
(a.a.) with and without use of HVE and the added effect of a
ceiling mounted air purifier (Phantom) used on different
settings in an 8x10 foot operatory with an 8-foot ceiling. The
figure shows a 95 percent reduction in aerosols due to use of
HVE alone when adjusted at optimal velocity and positioned
close to the operating site during a.a use

17. Saliva ejector
• Low volume suction devices
• 300 ml/ min is the suction rate
• Adjunct to high volume vacuum/ rubber dam/cotton
rolls
Uses
Removes saliva from the floor of mouth
Removes water slowly

18. Suction tips/ saliva ejectors
Disposable saliva ejectors
- Transparent [ plastic]
- Multi coloured [ plastic]
- Hygoformic saliva ejector
- Mirror vac
- Lingua fix

19. - Steel
- Saliva ejector with tongue guards
Reusable saliva ejectors

20. Svedopter
• Metal saliva ejector with a tongue retractor
• Used for mandibular arch
• Most effective when patient is in a nearly upright
position.

21.  Commonest and cheap
 Preparation in maxillary arch in mandibular arch
Cotton rolls

22. Controls small amounts of moisture and retracts
cheek and tongue
Keeps its shape and does not fall apart when full
of saliva
Provides acceptable dryness for procedures
Cementation
Impression making
Uses

23. Different types of cotton rolls
Wrapped
Braided

24. Cotton roll holder
 Holds cotton rolls in place
Advantages
• Cheek and tongue are slightly
retracted
• Enhances visibility

25. Absorbents
 Useful for short period of isolation
 Alternatives when rubber dam application is
impractical
 Retracts cheek & provide absorbency

26. Different absorbent devices
 Dry tips
 Reflective shields

27. Dry tips
[Moisture absorbing cards]
Keeps parotid gland in check for 15 minute
Absorbs more moisture compared to cotton rolls

28. Reflective shields
 Mirror-like reflective film allows illumination
 Checks saliva control for parotid gland
 Ideal for sealant and dental hygiene procedures

29. Chemical methods of fluid control
Administer for patient with excessive salivation
Anti- sialagogues
Local anesthetics

30. Anti sialagogues
• Gastrointestinal anti cholinergic drugs that inhibit action of
myo-epithelial cells of salivary gland
Common drugs
• Bromide (Banthine) 50 mg 1 hr before procedure
• Propantheline bromide (Pro-Banthine) 15mg 1 hr before
procedure
• Clonidine hydrochloride (Antihypertensive) 0.2mg 1 hr before
procedure
• Atropine 1 tablet of 0.4mg per day

31. Contraindication of anti-sialogogues
Methantheline and propanthelin contraindication
Hypersensitivity to drugs
Glaucoma
Asthma
Congestive heart failure
Obstructive condition of GI tracts or urinary tracts

32. Clonidine hydrochloride
• Its an anti hypertensive drug hence should be
given cautiously
• Causes drowsiness

33. Gingival retraction

34. Definition
• Gingival Retraction is the deflection of the
marginal gingiva away from a tooth.
• Gingival retraction is a process of exposing
margins when making impression of prepared
teeth.

35. Need of gingival displacement
• For accurate impressions in case of finish line at or
below the gingival sulcus.
• For restoration of cervical lesions

36. Classification of gingival tissue displacement
Non-surgical Surgical
Mechanical Mechano-chemical

37. Non surgical gingival
retraction

38. Mechanical methods
 Retraction crown/sleeve
 Mechanical retractor
 Retraction cord

39. Mechano- chemical
 Retraction cord with hemostatic
 Retraction paste with hemostatic

40. Retraction crown /sleeve
Temporary crown adapted to the finish line
Excess of temporary material lined on the finish line
Crown placed on prepared tooth
Excess material is removed

41. Disadvantages of retraction crown/sleeve
• Recession of gingiva in case it is placed for more
than 12 hours
• Delayed impression
• Cervical region of teeth becomes sensitive and
susceptible to caries

42. Anatomic compression cap
Anatomic compression caps placed on patient’ s
teeth
Instruct the patient to bite on it

43. Advantages of compression cap
• Stops bleeding due to compression
• Opens the sulcus wide
• Ensures clean , dry area with well defined
gingival margin

44. Modified impression
techniques

45. Copper band impressions
Means of carrying the impression material and a
mechanism for gingival retraction.

46. Gingival margin are crimped to adapt to gingival contour

48. Temporary acrylic resin coping constructed
Tray adhesive applied
Filled with elastomeric impression material and reseated
Tissue displacement occurs
Full arch impression made
Temporary acrylic coping

49. Gingival protector
• It has a crescent shaped tip on an adjustable
ball joint attached to a metal handle
Uses
Veneer preparation
Finishing porcelain/resin
Sub gingival caries
Check fitting of margins of crown

50. Matrices and wedges
Placed inter proximally
Uses
Depresses gingiva
Matrices with gingival extension provides
displace gingival tissue

51. Rubber dam
• Heavy and extra heavy rubber dams were used
• Retraction is done by rubber dam and clamps
(No. 212 cervical retainer)
• Produced retraction by compression

52. Advantages
 Control of seepage and hemorrhage.
 Ease of application.
Disadvantages
 Full arch models cannot be made.
 Severe cervical extension
preparations.
 Cannot be used with polyvinyl-
siloxane impression materials

53. Mechano chemical
method

54. Gingival retraction cords
Gingival retraction cord is a tapered diameter cord
that can be wrapped several times about a tooth
that causes flared gingival crevice.
Plain cord provides mechanical retraction
Gingival retraction using chemically impregnated
retraction cord is a mechanico-chemical method of
displacement

55. Classification of retraction cords
Depending on the configuration
Twisted
Knitted
Braided
Depending on surface finish
Wax
Unwaxed

56. Depending on the chemical treatment
Plain
Impregnated
Depending on number strands
Single
Double-string

57. Depending on the thickness (color coded)
Black - 000
Yellow - 00
Purple - 0
Blue - 1
Green - 2
Red - 3

58. Desirable properties of retraction cord
• Dark color maximizes contrast with tooth & tissue
• Absorbent – can take liquid medicament
• Available in different diameters

59. Twisted gingival retraction cords
Allow the dentist to customize the cord as
individual strands can be removed

60. Knitted gingival retraction cord
• Interlocking loops
• Longitudinally elastic
• Transversely resilient

61. Braided gingival retraction cord
Firm
Flexible
Multistrand

62. Indications of #000
Anterior teeth
Double packing
Substitute for black silk
suture as lower cord in
the "two-cord" technique

63. Indications of #00
• Preparing and cementing
veneers
• Restorative procedures
dealing with thin, friable
tissues

64. Indications of #0
• Lower anteriors
• When luting near gingival and
subgingival veneers
• Class III, IV and V restorations
•
• Second cord for "two-cord"
technique

65. Indications of #1
• Tissue control and/or displacement
when soaked in coagulative
hemostatic solution prior to and/or
after crown preparations
• Protective "pre-preparation" cord
on anteriors

66. Indications of #2
• Upper cord for "two-cord" technique
• Tissue control and/or displacement
when soaked in coagulative
hemostatic solution prior to and/or
after crown preparations
• Protective "pre-preparation" cord on
anteriors

67. Indications of #3
• Areas that have fairly thick
gingival tissues where a
significant amount of force is
required
• Upper cord for those desiring
the "two-cord" technique

68. Instruments used for gingival retraction
• Evacuator
• Scissors
• Cotton pliers
• Mouth mirror
• Explorer
• Fisher ultrapak packer
• DE plastic filling instrument IPPA

69. • Cotton rolls
• Retraction cord
• Hemodent liquid
• Dappen dish
• Cotton pellets
• 2x2 gauge sponges

70. • Small Packer (45 degrees to handle)
• Small Packer (90 degrees to handle)
Fischer ultrapakpackers

71. 45 degrees
Heads at 45 degrees
Three packing sides.
Small packer for
lower anteriors and upper lateral incisors.
90 degrees
Three sided heads
One of the heads in line with shank
Second is at a right angle to the shank.

72. Single cord technique.
Double cord technique.
Infusion technique of gingival displacement.
Every other tooth technique.
Techniques of gingival retraction

73. Technique of cord placement
Retraction cord drawn
from bottle

74. Twisting of retraction cord

75. Looping of gingival cord

76. Cord placement from
mesial surface
Placement of cord
sub gingivally

77. Occasional use of extra instrument to hold
the cord and packing with other

78. Instrument must be angled towards
the root

79. Excess cord cut off in the mesial
area

80. Placement of distal end till it s overlapping
the mesial part of cord

81. Double cord technique
Indication
• Impression of multiple prepared teeth
• Impression for compromised tissue health

82. Procedure
Small diameter cord is placed in sulcus
Second cord soaked with hemostatic agent
Placed over small cord for 8-10 minutes
Impression made

83. Infusion technique
Indication
 Controls hemorrhage
Procedure
Retraction cord packed into the sulcus for 1-3 minutes.
Infuser used with a burnishing motion in the sulcus
circumferentially 360° around the sulcus

84. Every other tooth technique
Anterior tooth preparation when the roots are
in proximity
Prevents collapse of gingival papilla.

85. Gingival displacement medicaments
• Chemicals used along with retraction cords
are classified as
Vasoconstrictors
Astringents

86. Mechanism of action of vasoconstrictors
Physiologically restricts blood supply to the area by
three ways
 Decreasing the size of the blood capillaries
 Tissue fluid seepage
 Consequently size of the free gingiva.
(Ex: epinephrine and norepinephrine)

87. Epinephrine
• 0.1%-8% racemic epinephrine is used
• 0.2 mg -1 mg of epinephrine per inch of cord

88. Contraindications of epinephrine
Cardiovascular disease
Hypertension
Diabetes
Hyperthyroidism
Known hypersensitivity to epinephrine
Patients taking
Mono-amineoxidase
Tricyclic depressants
Ganglionic blockers
Cocaine

89. Sympathomimetic amine
Tetrahydrozoline HCL- 0.05%
Oxymetazoline-0.05%
Phenyl epinephrine HCL-0.05%
Advantages
More acceptable pH

90. Astringent
Mechanism of action
 Precipitation of protein
 Inhibit tran-scapillary movement of plasma protein
Act as caustics at low concentration & irritants in
moderate concentration.
Low cell permeability.

91. Alum (Potassium aluminium sulfate)
100% of alum soaked in retraction cord
Advantages
Safer and fewer systemic effects than
epinephrine
Good tissue recovery
Can be placed inside the sulcus safely for 20 min
Disadvantages
0.1% of crestal bone loss

92. Aluminum chloride
Mechanism
Precipitate protein
Constrict blood vessels
Extract fluid from tissues
 Used in 5-25% concentration for 10 min
 Least irritating
Disadvantage
Interferes with the setting of PVS materials

93. Ferric sub-sulfate
• Also known as monsel’s solution
• More effective than epinephrine
• Good tissue recovery
• Recommended time- 3 min
Disadvantages
Solution is messy
Corrosive and injurious to soft tissues
Stain teeth
High acidity

94. Ferric sulfate
Recommended concentration-13- 20%
Provides hemostasis on exposed connective tissue
Recommended packing time-1-3 min
Disadvantages
Modify setting reaction of polyvinyl siloxane
Stains gingival tissue yellow-brown to black

95. Tannic acid
• Recommended concentration-20-100%
• Recommended time- 10 min
• Good tissue recovery

96. Drug Advantages Disadvantages
Epinephrine  Good tissue displacement
 Minimal tissue loss
 Good hemostasis
 Systemic reactions
 Epinephrine syndrome
Alum  Minimal tissue loss
 Extended working time
 Less hemostasis &
tissue displacement
Aluminum chloride  Minimal tissue loss
 Good hemostasis
 Local tissue destruction
Ferric sulfate  Compatible with aluminum
chloride
 Good displacement
 Non compatible with
epinephrine
 Tissue discoloration
Tannic acid  Good tissue response  Less displacement
 Minimal hemostasis

97. • 1) 20% ferric sulphate, 2) 15.5% ferric chloride, 3) 21.3% aluminium
sulphate, 4) aluminium chloride, 5) 8% epinephrine.
• Chemicals containing iron and epinephrine should not be used while
managing the tissues as they cause black discolouration which is
unaesthetic. Aluminium containing chemicals can safely be used in
retraction cords .
Manikya Arabolu , Effect of chemicals impregnated in the retraction cords on
freshly prepared teeth, KDJ - Vol.34, No. 1, January 2011

98. Surgical method

99. Rotary gingival curettage
“Gingitage” or “Denttage”
Troughing technique
Purpose is limited removal of epithelial tissue
while a chamfer finish line is being created
Amsterdam gave the concept further developed
by Hansing and Ingraham.

100. Criteria for rotary curettage
Done on healthy and inflammation free tissue to
prevent tissue shrinkage
Absence of bleeding on probing
Sulcus depth less than 3.0 mm
Presence of adequate keratinized gingiva

101. Technique
Shoulder finish line preparation prepared at
gingival crest using flat end tapered diamond
Finish line extended apically1/2-2/3 the depth of
the sulcus by torpedo diamond
Aluminum chloride impregnated retraction cord
placed in sulcus
Cord removed after 4-8 minutes

102. Shoulder prepared at the
gingival level
Torpedo diamond bur to form
chamfer finish line and removal
of epithelial sulcus
Cord placed in the troughed sulcus

103. Electro Surgery
 Electrosurgery denotes surgical reduction of
sulcular epithelium using an electrode to produce
gingival retraction

104. Mechanism of action
Controlled tissue destruction.
Current flows through a small cutting electrode
a vacuum tube or a transistor to deliver a high
frequency electrical current of at least 1.0 MHz
The procedure is also called as “Surgical
Diathermy”

105. Types of current
Fully Rectified current (modulated)
• Continuous flow of current
• Good cutting characteristics
• Enlargement of gingival sulcus
Fully Rectified current (filtered)
• Continuous current wave
• Excellent cutting characteristics
• Less injury than modulated current

106. Partially rectified current (damped)
Considerable tissue destruction.
Slow healing.
Used for spot coagulation
Un rectified current (damped)
Recurring peaks of current that rapidly
diminish.
Causes intrinsic dehydration and necrosis.
Slow and painful healing.
Not used in dental surgery.

107. Un rectified damped current
Fully rectified filtered
current
Fully rectified current
Partially rectified damped
current

108. Tissue considerations
Keep electrode in motion.
5-10 seconds between applications.
Patient should be properly grounded.
Tissue must be moist.
Electrode must remain free of tissue fragments.
Electrode must not touch any metallic restorations.

109. Advantages
Clear operating area without or no bleeding
Healing by primary intension
Less tissue loss after healing

110. Disadvantages
Unpleasant odour.
Slight loss of crestal bone
Burn mark on the root surface
Not suitable for thin gingiva.

111. Contraindications
Patients with cardiac pace maker.
Patients with delayed wound healing.
Patients on steroid therapy.
In the recently irradiated areas.

112. Technique
Anesthesia
A drop of aromatic smelling oil.
Complete seating of electrodes in handpiece.
Light pressure and quick ,deft stoke
5-10 seconds between each stroke.

113. Grounding
 For patient’s safety
 Circuit should be complete by using ground
electrode
Ground
Back to the unit

114. Tissue Goo
Composition
 25% aluminum sulfate and colorants
 Medium viscosity, not too thick

115. Matrix impression system
(Described by Levaditis)

117. Lasers
Indication
Controlled tissue removal before impression
making
Tissue contouring
Properties of laser depends on
Wavelength
Waveform

118. Types of lasers
Neodymium: yttrium-aluminium-garnet
Erbium: yttrium- aluminum-garnet

119. Advantages
Advantage
Minimum pain and discomfort
Less fear ,anxiety and stress
Minimum or no anesthesia
No drill sounds
Less chair time
Reduced post operative complications
Minimum or no bleeding
Disadvantage
Overuse causes shrinkage of tissue and also results in
exposure of crown margin

120. • Introduced by Satalec Pierre Rolland
• Cordless gingival retraction (SDS/Kerr Company)
Composition
Aluminum chloride-15% astringent & hemostatic
agent
Kaolin
Excipients
Expasyl

121. Mechanism of action
• It has both mechanical and chemical action
Aluminum chloride provides- hemostasis
Viscosity of Kaolin- retracts the tissue
Recommended time of application-1-2 min

122. Advantages
Effectively achieves hemostasis.
Effectively retracts gingival tissues
Less traumatic to tissues than cord packing.
Faster than traditional cord.
Easy removal from sulcus by rinsing.
Dispenser tips can bent- improves intraoral access.

123. Disadvantages
Expensive
Effective under limited conditions.
Disposable metal dispenser tips are too large
causes difficulty to express
Thickness makes it difficult to express

124. Precautions
Thorough cleaning is mandatory to prevent
interference in polymerization of poly vinyl
siloxane materials
Contraindications
Presence of periodontal pocket and furcation
Known allergy to aluminum chloride

125. Inclined to be near the
edge of the marginal
gingiva
Tip of canula Pushed against the
tooth surface
Placement of metal dispenser

127. Magic foam
 Developed by Prof Dr. Dumfahrt
Non-hemostatic gingival retraction system
(Coltène/ Whaledent)
 First expanding vinyl polysiloxane material
designed for retraction of the gingival sulcus

128. Mechanism
• Expansion of silicon foam
Limitation
Limited clinical indications
Less hemostatic
No improvement in speed/quality compared
to cord
Less effective on sub gingival margin

129. Components of magic foam
• Foam
• Cartridges
• Mixing and intraoral tips
• Comprecaps

130. 60 subjects who required metal ceramic restoration
Mean vertical displacement
• Expasyl -0.72 mm
• Medicated retraction cord-0.49 mm
• Magic foam-0.38 mm
Mean gingival retraction width
• Expasyl -0.37 mm
• Medicated retraction cord- 0.29 mm
• Magic foam- 0.26 mm
Rao et al; Comparative evaluation of gingival displacement using expasyl,
magic foam cord and medicated retraction cord-An vivo study, TPDI ,January
2012, Vol.3,No.1

131. Gingitrac (Centrix co)
Mild natural astringent gel
Utilizes patient s bite pressure to push material
into sulcus and retract gingiva
Consists of
Mixing gun
Gingitrac cartridge
Gingitrac matrix cartridge
Mixing nozzle
Dispensing tips
Gingicap

133. Advantages
Less traumatic to tissues than retraction cord
Color of foam makes it easy to see during use
Easy to remove material from preparation and
sulcus
Adequate working time

134. Disadvantages
Limited clinical indications
No hemostasis provided
Relatively expensive compared with retraction
cord
No improvement in speed or quality of retraction
compared with cord
Less effective on sub-gingival margins
Intraoral tips may be too large to adequately inject
material into sulcus

135. Merocel strips
• Marco Ferrari et al in 1996 found Merocel
• Synthetic material that is biocompatible polymer
(hydroxylate polyvinyl acetate)

136. Mechanism of action
• Expands by absorption of oral fluids and exerts
pressure on surrounding tissue

137. Method
About 2 mm of merocel retraction strip
Provisional crown inserted
Maintain pressure on crown for 10-15 min

138. Advantages
Easily shaped and adapted around tooth
Highly effective in absorption of oral fluids
Chemically pure- no post surgical complications
Non abrasive

139. • 14 maxillary tooth requiring complete metal ceramic
restoration
• Retraction was done using merocel and
conventional method
Mean vertical retraction of gingival cord - 2.02
Mean vertical retraction of retraction strips - 2.78
Shivashakthy M, Comparative study on the efficacy of gingival retraction using
polyvinyl acetate strips and conventional retraction cord - An in vivo study ,
Journal of clinical and diagnostic research, 2013 Oct Vol-7(10)

140. Stay put retraction cord
Fine metal filament reinforced displacement cord
impregnated or non impregnated
Consist of braided retraction cord and ultrafine
copper filaments
Remains in shape and does not deform

141. Traxodent
• Syringe-dispensed 15% aluminum chloride,hemostatic paste
• Ergonomic syringe
• Easy to use
• Disposable and flexible tips
• Each syringe can be repacked for maximum freshness
• Paste with a malleable consistency

142. Gingival displacement in digital impressions
15% aluminum chloride in an injectable matrix
Cords avoided to prevent artifacts on digital
impression

143. Retraction Capsule
• Astringent retraction paste supplied in a single-use
capsule
• The retraction paste contains 15% aluminum chloride
and can be used alone or in conjunction with retraction
cord for all indications requiring temporary deflection of
marginal gingival

145. Aim : to investigate the pressures generated by 4 different cordless
gingival displacement materials.
A chamber with a dimension of 5x5x2 mm was made from Type IV stone
and silicone material to simulate a rigid and elastic environment. A
pressure gauge was embedded into the wall of the chamber
The pressure generated by cordless systems is more than 10 times less
than with displacement cord, and this could result in inadequate
displacement
The median post injection pressures generated by Expasyl (142.2 kPa)
and Expasyl New (127.6 kPa)
3M ESPE Astringent Retraction Paste (58.8 kPa) and Magic Foam Cord
(32.8 kPa).
Bennani .V etal Comparison of pressure generated by cordless gingival displacement
materials J Prosthet Dent 2014;112:163-167

146. Gingival retraction in implants
Indicated only in rare situations
• Fabrication of custom abutment
Only injectable matrix technique used
Chang YSM etal Effect of a cordless retraction paste material on implant surfaces:
an in vitro study,Braz Oral Res. 2011 Nov-Dec;25(6):492-9

147. G-Cuff
• G-Cuff Non-Invasive Tissue management
• Provides immediate tissue displacement for transfer
emergence profile modeling as a recipient for the resin
• For clean cementation as a cement barrier

148. Polymerization time compatibility index of polyvinyl siloxane
impression materials
The study comprised 10 gingival displacement agents
5 conventional astringents:
(10%, 20%, and 25% aluminum chloride, 25% aluminum sulfate,15.5% ferric sulfate)
5 experimental adrenergics:
(0.1% and 0.01% HCl-epinephrine, 0.05% HCl-tetrahydrozoline, 0.05% HCl-
oxymetazoline, and 10% HCl-phenylephrine).
It is important to avoid or minimize the direct contact of chemical displacement
agents with PVS during gingival displacement and impression procedures.
15.5% ferric sulfate from CDA group and 0.01% HCl-epinephrine and 0.05% HCl
tetrahydrozoline from the EDA group were identified in this study as optimal under
clinical conditions.
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