DESIGN AND DEVELOPMENT OF DENTAL TRAYS

FOR CLEFT PALATE BABIES

A thesis submitted in fulfilment of

The requirement for the award of the degree
Of

Master of Technology
In
Computer Aided Design and Computer Aided
Manufacturing
Submitted
By
SATYA PRAKASH
(MT15CDM016)

Under the Supervision of

Dr. A.M. KUTHE

Department of Mechanical Engineering

Visvesvaraya National Institute of Technology, Nagpur 440010
June 2017
© Visvesvaraya National Institute of Technology (VNIT) 2017
 DEPARTMENT OF MECHANICAL ENGINEERING
VISVESVARAYA NATIONAL INSTITUTE OF TECHNOLOGY
NAGPUR 440 010 (INDIA)
2015 – 2017

DECLARATION

I hereby declare that the thesis titled “Design and Development of Dental Trays for
Cleft Palate Babies” submitted herein for the award of Degree of Master of
Technology has been carried out by me at VNIT, Nagpur. The work is original and
has not been submitted earlier as a whole or in part for the award of any
degree/diploma at this or any other Institution/University.

Satya Prakash
MT15CDM016
CAD-CAM Engineering
VNIT-Nagpur
 DEPARTMENT OF MECHANICAL ENGINEERING
VISVESVARAYA NATIONAL INSTITUTE OF TECHNOLOGY
NAGPUR 440 010 (INDIA)
2015 – 2017

CERTIFICATE

The study titled “Design and Development of Dental Trays for Cleft Palate Babies”
submitted by Satya Prakash for the award of degree Master of Technology, has been
carried out at VNIT, Nagpur. The work is comprehensive, complete and fit for
Evaluation.

Dr. A. M. Kuthe
Professor
Dept. of Mechanical Engineering,
VNIT, Nagpur

Dr. S.B. Thombre

Head, Department of Mechanical Engineering
VNIT, Nagpur.
Date:
 ACKNOWLEDGEMENT

My deepest gratitude is to my guide, Dr. A. M. Kuthe. I have been amazingly

fortunate to have a guide who gave me the freedom to explore on my own and at the
same time guidance to recover when my steps flattered. His patience and support
helped me overcome many crisis situations and finish this dissertation.

I am thankful to Dr. S. B. Thombre, Head department of Mechanical Engineering, for

extending the department facilities for my research work.

This project was conceptualized by Dr. Ritesh Kalaskar (GDC, Nagpur) and I am
grateful to him for giving me opportunity to work on such an innovative project and
for sparing his valuable time to guide me. I am indebted to him for taking interest and
giving suggestions throughout.

I am also highly indebted to Mr. Asutosh Bagde, Mr. Sandeep Dhake and Mr.
Gangadhar of CAD- CAM centre for allowing me to use the equipment. I would also
like to thank Mr. Rakesh Pokulla, Ms. Saniya Parvez, Mr. Manish Kamat and Mr.
Jyothilal for helping me during thesis preparation.

Lastly I would like to acknowledge my family and friends for supporting me in my

endeavour.

SATYA PRAKASH
 ABSTRACT
Babies with cleft palate have trouble in feeding because the normal anatomy of oral
cavity is disrupted. The project aims to design assistive device for babies suffering
from this deformity.

The main problem faced by cleft palate babies is their incapability to produce
sufficient negative pressure in oral cavity. Due to this they are unable to get the
desired inflow of milk and babies suffer from fatigue and malnutrition. Currently
doctors use feeding plate developed separately for individual babies. The feeding
plate seals of the cleft in both lip and palate this enables the infant to pull nourishment
from conventional bottles.

Development of feeding plate requires the generation of accurate impressions of

patient’s palate. Presently for impression doctors use their fingers to spread the
impression compound in the patient’s mouth and pull the impression out after it sets.
This procedure has several drawbacks. The project deals with design and development
of dental tray which conform to the average cleft profile to provide accurate
impression without increasing the anxiety level of doctor.

These trays are designed in four sizes for the doctor to select from based on the facial
anatomy of the patient. Lastly acrylic is used for fabrication of the trays as it is
biocompatible.

The acrylic tray is to be clinically tested to validate its success. First is by comparing
the anatomical resemblance of impression obtained by hand versus that taken using
dental tray. Secondly anxiety level of practising dentist can be compared in both
situations by measuring the heart rate while taking the impressions.

i
 List of Figures
Figure 1.1 Cleft Palate Anatomy ................................................................................... 1
Figure 1.2 Types of cleft Palate Patients ....................................................................... 2
Figure 1.3 Types of cleft Palate Patients ....................................................................... 3
Figure 1.4 Impression procedure at GDC Nagpur, by Dr Kalaskar............................... 4
Figure 1.5 Methodology Framework ............................................................................. 6
Figure 3.1 Steps in the processing of acrylic materials ............................................... 20
Figure 4.1POP samples of right cleft of 8 newborns ................................................... 21
Figure 4.2 Critical points ............................................................................................. 22
Figure 4.3 Use of CMM ............................................................................................... 23
Figure 4.4 Point Cloud Data ........................................................................................ 23
Figure 4.5 Point Coordinates ....................................................................................... 24
Figure 4.6 Point Cloud in Solidworks ......................................................................... 24
Figure 4.7 Surface model of palate .............................................................................. 25
Figure 4.8 CAD model of Dental Tray ........................................................................ 26
Figure 4.9 Stratasys 3D Printer .................................................................................... 26
Figure 4.10 RP of the Dental Tray ............................................................................... 27
Figure 4.11 Scaling to Tray 2 ...................................................................................... 29
Figure 5.1 Two sides of RP tray .................................................................................. 30
Figure 5.2 Gypsum Mould ........................................................................................... 31
Figure 5.3 Separating media applied ........................................................................... 31
Figure 5.4 Acrylic dough ............................................................................................. 32
Figure 5.5 Mould space filled with acrylic resin ......................................................... 32
Figure 5.6 Excess flash removals................................................................................. 33
Figure 5.7 Flask containing Tray ................................................................................. 33
Figure 5.8 Acrylic Tray with flash and gypsum .......................................................... 34
Figure 5.9 Finishing kit & Trimming of Tray.............................................................. 34
Figure 6.1 Acrylic Tray 1............................................................................................. 35

ii
 List of Tables

Table 3-1 Composition of heat activated acrylic resin ................................................ 18

Table 3-2 Composition of self cure acrylic resin ........................................................ 18

iii
 Table of Contents
ABSTRACT .................................................................................................................... i

List of Figures ................................................................................................................ii

CHAPTER 1: INTRODUCTION ................................................................................ 1

1.1 BACKGROUND ............................................................................................. 1

1.2 FEEDING PROBLEMS .................................................................................. 2
1.3 PROBLEM DEFINITION .............................................................................. 3
1.4 OBJECTIVE.................................................................................................... 5
1.5 METHODOLOGY FRAMEWORK OF PROJECT ....................................... 5
1.6 THESIS OUTLINE ......................................................................................... 7
CHAPTER 2: LITERATURE REVIEW ..................................................................... 8

CHAPTER 3: THEORETICAL BACKGROUND ................................................... 13

3.1 INTRODUCTION TO IMPRESSION MATERIALS .................................. 13

3.1.1 Classification of Impression Materials .................................................. 14
3.1.2 Impression compound ............................................................................ 15
3.2 DENTAL TRAYS ......................................................................................... 17
CHAPTER 4: DENTAL TRAYS DESIGN .............................................................. 21

4.1 DATA COLLECTION .................................................................................. 21

4.2 SOFTWARE MODEL OF TRAY ................................................................ 24
4.3 RP MODEL OF TRAY ................................................................................. 26
4.4 SIZING OF DENTAL TRAYS .................................................................... 27
CHAPTER 5: DEVELOPMENT OF TRAYS .......................................................... 30

5.1 MATERIAL SELECTION ........................................................................... 30

5.2 FABRICATION OF TRAYS ........................................................................ 30
CHAPTER 6: RESULTS AND CONCLUSION ...................................................... 35

6.1 Results and Conclusion ................................................................................. 35

CHAPTER 7: Future Scope....................................................................................... 36

REFERENCES ........................................................................................................................ 37

iv
 CHAPTER 1: INTRODUCTION

1.1 BACKGROUND

Infants spend most of their early weeks in feeding and sleeping. Feeding satisfies the
hunger and thirst of the infant as well as it creates a bond between mother and child.
Babies use rhythmic intra oral muscular movements while getting fed. This
mechanism is hampered in case of cleft in the oro-facial region; cleft means ‘split’ or
‘separation’ between two parts. A cleft occurs when separate areas of face do not fuse
together during the development of the foetus.

The cleft deformities are the most common of the pediatric congenital anomalies and
their incidence approximately ranges from 1 per 700 live births worldwide [1]. While
in India it is approximately 9 per 1000 in the Nagpur region [1]. A majority of cleft
births occur in rural area where illiteracy, poverty and misinformation are rampant
and access to medical resources is scarce.

Figure 1.1 Cleft Palate Anatomy

The type and severity of the cleft vary depending on the fusion defect it can involve
different regions such as hard palate, soft palate and lip either independently or in
combination. So cleft lip and palate are commonly categorized into three main types:-

1
  Cleft lip(CL)

 Cleft palate(CP)

 Cleft lip and palate(CLP)

These can be subcategorized into incomplete or complete clefts and unilateral or

bilateral cleft. A cleft on one side of face is called unilateral cleft and a cleft on both
sides called bilateral cleft as shown in figure 1.2 [2].

Figure 1.2 Types of cleft Palate Patients

1.2 FEEDING PROBLEMS

The action of drawing milk into the mouth is called sucking. Functionally it is defined
by the amount of time it takes for an infant to consume a given volume of liquid. In
normal infants the efficient sucking is produced by a negative pressure which is
generated by tight lip seal around the nipple, elevation of soft palate to close of the
nasopharynx and expanding the intra oral cavity. This is a coordinated neuromotor
function. In case of infants with cleft this function is disturbed due to abnormal

2
muscle attachments and abnormal communication between nose and oral cavity. Thus
it becomes difficult to build negative pressure and create suction. So infants with cleft
have severe feeding difficulties related to their reduced sucking efficiency [3]. The
most notable problems infants undergo are insufficient suction, excessive air intake,
choking, nasal regurgitation, fatigue, inadequate milk intake, failure to gain weight,
and excessive time required to feed. In ability to feed properly may lead to maternal
stress and anxiety thus leads to poor mother and infant bonding. Growth retardation is
also observed specially during the first few months of life. The feeding problems and
their interrelationship are shown schematically in figure 1.3 [3].

Figure 1.3 Types of cleft Palate Patients

1.3 PROBLEM DEFINITION

The first step in the rehabilitation of a cleft infant is taking the impressions to develop
feeding plates which are a useful aid in feeding. An impression is defined as the
negative replica of oral tissue. Currently there are no dental trays available for the
cleft palate babies due to complex anatomy associated with the cleft. So doctors today

3
hold the impression compound in hand and put it in the baby’s mouth till it sets and
after this it is withdrawn.

Figure 1.4 Impression procedure at GDC Nagpur, by Dr Kalaskar

This procedure to take impression by hand has major drawbacks such as:-

1) Accuracy of impression by hand is less because of manual error. Only very

experienced practitioner can take an impression without anxiety and trembling
of hand.
2) Impression compound needed is more so there is risk of entry of particles into
the baby’s food canal. This may lead to dangerous consequences such as
choking.

4
1.4 OBJECTIVE
The goal of this research work is to improve the current procedure of impression by
practioner for cleft palate babies. So the steps involved are:-

 Design of Dental trays to obtain palate impression of left cleft and right cleft
patients from 1 to 6 months of age.

 Fabrication of trays using suitable biocompatible material.

1.5 METHODOLOGY FRAMEWORK OF PROJECT

At first stage of the project problem was identified in obtaining impression of palate
for cleft palate babies. Then after literature review the various problems faced by cleft
palate babies and current solutions were understood. After discussion with Dr
Kalaskar the anatomy of palate and various critical dimensions for the design of tray
was identified. For collection of data 8 POP samples of new born babies with right
cleft were procured from Government Dental College, Nagpur. Critical points were
marked on each of the samples and three dimensional coordinates were obtained using
CMM machine. These coordinates were averaged and imported in Solidworks
software. The three dimensional model was prepared and rapid prototype was printed
in Acrylonitrile Butadiene Styrene and design was approved by the pedodontist. The
model was scaled to meet the requirement of different jaw sizes and growth of babies.
In next step various biocompatible material were identified out of which heat activate
acrylic resin was selected for fabrication of tray. Acrylic tray was processed at GDC,
Nagpur using compression molding technique. Following figure 1.5 shows the
methodology adopted for project.

5
 Problem Identification and
definition

Literature Review

To understand the anatomy of cleft

palate

Various critical points identified and marked

on the on the POP sample

Point cloud data obtained using CMM

3D model prepared in Solidworks

software

RP model printed in ABS

Design approved by the dentist

Acrylic tray processed in four

different sizes at GDC, Nagpur

Figure 1.5 Methodology Framework

6
1.6 THESIS OUTLINE

This thesis is divided into seven chapters. The current chapter begins with the
background and contains problem statement, methodology framework of project. The
objective for this thesis work was framed after literature review and this chapter ends
with outline of the thesis. Chapter two contains the literature review which gives an
overview of previous research in the area. Chapter three contains detailed information
about impression materials, procedures and various materials available for processing
of dental trays. The design of dental trays is explained in chapter four and Chapter
five contains the various steps in the manufacturing of dental trays. Chapter six
summarizes the key results of this thesis and chapter seven provides recommendation
of future work on this thesis.

7
 CHAPTER 2: LITERATURE REVIEW

Ritesh Kalaskar, et al [1]

Evaluates the environmental risk factors associated with cleft lip and palate and
prevalence of the abnormality in Nagpur region of India. The study was conducted by
department of pedodontics and preventive dentistry GDC Nagpur. The infants are
divided in to two groups first group consists of 88 infants with CLP and CP it was
called as study group. The second comparison group consists of 88 infants with no
developmental defects. The parents of infants were subjected to questionnaire such as
socio demographic profile of parents, family history of cleft, maternal dietary or
nutritional history during pregnancy, maternal medical history such as diabetes
pregnancy induced hypertension, history of drug consumption during pregnancy,
parental history of alcohol consumption ,cigarette smoking etc. Additional
information about mother’s haemoglobin level was also obtained from the hospitals.
A total of 9333 infants reported to the department during study. The non syndromic
case of CLP was 0.66% and for CP was 0.27% respectively. Of the cleft palate babies
22% had the family history of cleft whereas sibling association was in 3% of the
cases. Most parents of cleft babies were in lower socioeconomic class followed by
middle class and then higher class. Nutritional deficiency was most frequently found
in mothers of study group ~76% compared to comparison group mothers ~14%.
Positive history of self medication was significant in study group mothers~ 84% as
compared to only 14% of the comparison group mothers. None of the mothers
volunteered a positive history of alcohol consumption. Tobacco consumption and
smoke from other sources (fire wood and burned coal) the data was not significant.
Study group mothers have more reduced haemoglobin level (~63%) as compared to
comparison group mother. Blood transfusion was more 53% in study group mothers
compared to comparison group mother. Thus several environmental risk factors
changes the genes which cause cleft and thus play an important role in the
development of cleft lip and palate in central region of India.

8
E. Sree Devi, et al [3]

This article reviewed devices and techniques which help in successful management of
cleft palate babies. The primary problem of feeding in cleft babies is due to inability
to generate negative pressure because of the cleft in the palate. The babies with cleft
lip or palate or both swallow normally but suck abnormally. A lip seal was found to
be less important as compared to a posterior oral seal as found by measurements of
negative pressure using a pressure transducer in the feeding bottle teat. Infant with
cleft palate with or without cleft lip had zero intra oral pressure, whereas infants with
only cleft lip were successfully able to generate negative intra oral pressure. Isolated
cleft lip feeding was generally adequate till the air leak from cleft stops the generation
of negative pressure. Breast feeding is ideal in such situations as it conforms to the
defect. Artificial nipples with large soft base are also effective when breast feeding is
not desired. In case of isolated cleft palate babies, breast feeding can be tried when the
cleft is narrow and posterior however it is less effective in case cleft is on hard palate.
Regular bottle feeding cannot be applied but enlarging the nipple opening and using
softer nipple enables the tongue movements to express milk. If the cleft involves lip
and the palate then regular bottle feeding or breast feeding did not work. Any feeding
device that delivers sufficient volume of milk and allows swallowing the milk will
work. A soft plastic bottle which will give the feeding person control over the volume
of milk in the infant’s mouth will be useful in this situation. In case of cleft on soft
palate only infants were fed normally, and if feeding was difficult a nipple with
boarder and longer shaft solved the issue. The feeding devices are normally of two
types one which blocks the oral cavity with nasal cavity and secondly which decrease
the need for the baby to suck thus changing the feeding process to primarily
swallowing process. An orthopaedic plate as reported by some authors closes off the
nasal cavity from oral cavity so that negative pressure is produced by suckling. But
contrary to this as found by Choi et al. [10] these plates did not produce any negative
pressure. In study conducted by Trenouth MJ and Campbell AN the feeding plates
were more effective in case of complete clefts as compared to cases of only posterior
clefts. Feeding plates provides a false palate against which the infant can suck [12].
Also it prevents the widening of cleft and helps in the development of speech. With its
continuous use it gives the maxillary cross arch stability and prevents arch collapse

9
after the surgical closure of lip. Most of the cleft rehabilitation centres advocate the
use of feeding plates in cases of complete unilateral or bilateral clefts. Soft squeezable
plastic bottles such as Mead- Johnson offers a flow rate that infant can handle. The
Haberman feeder allows the delivery of milk in response to compression of the teat by
the baby, no active suction being required. Various other devices such as Modified
cup feeding devices, specialized feeding teats are discussed. Lastly techniques for
feeding are explained as feeding techniques are also very important like feeding
devices.

Abhay aggrawal, et al [4]

This paper discusses the case of a three day neonate born with unilateral right cleft lip
and palate and it was diagnosed based on the complaint by his mother in feeding. So
a feeding appliance was made. It provides a seal between oral and nasal cavity and
thus help the neonate in generating negative pressure and express milk. The procedure
to fabricate feeding appliance is discussed. The first step in fabrication of feeding
appliance is to make preliminary impression using impression compound, cast is
poured on the impression compound and custom tray is made using self cure acrylic
resin. The tray is used to take the secondary impression to make the final cast. Using
pressure moulding technique in biostar and ethyl vinyl acetate (or bioplast) as the
material the feeding appliance is made. The various advantages of ethyl vinyl acetate
over acrylic plate are smoother surface and soft in nature. Floss was attached to the
feeding appliance so that it is not swallowed and easy retrieval is possible the child is
easily fed with the help of feeding appliance.

Rajesh Bansal, et al [5]

This paper presented the case of a one day old neonate suffering with Bilateral cleft
lip and palate for which palatal obturator was constructed.. Impression procedure is
critical in the fabrication of obturator. A number of positions have been adopted for
cleft palate infants including face down, upright and inverted upside down. Various
impression materials like alginate, low fusion impression compound and elastomeric
impression material have been employed for taking impression of cleft palate neonate.
Elastomeric impression material was used to take cleft impressions as these caused no

10
complications, have high tear strength, high elasticity and produces accurate details of
the surface, possesses good dimensional stability. The various bio materials available
in maxillofacial prosthetics are Acrylic resin, visible light cured acrylic, acrylic
polymer and silicones. Acrylic resin was selected for making the obturator because of
its easy availability and good strength. The obturator can help in reducing feeding,
and speech development in cleft lip patients.

Trenouth, M.J. et al [6]

A questionnaire evaluation was undertaken for feeding methods and their

effectiveness by mothers of 25 neonates with cleft lip and palate or only cleft palate.
Parents had problems with both the quantity of food taken by babies and the time
required to feed. Even after a period of two months one fourth had issues with
quantity of feed , a third were not able to fix a regular feeding pattern and just over
half needed to change the feeding method with which they started. Twelve mothers
tried to breast feed but none of them were successful. The Haberman feeder was most
widely used by 18 mothers. Acrylic feeding plate was helpful by 6 of 11 mothers of
babies with complete cleft but only one of nine mothers of secondary cleft. Almost all
the mothers were not satisfied with the information they received in hospitals and the
results when they went home.

Felix- Schollart B, et al [7]

General growth from birth to 2.5 years of age for 45 children with a non syndromic
cleft lip and/or palate was compared to that of 50 controls. Weight, height and head
were set as growth parameters and were studied in relation to possible influencing
factors. Feeding difficulties and intestinal disorder between 12 and 18 months of age
and airway infections between 0 to 3 months of age were identified as having negative
influence on growth measured by height and weight but not on head circumference.
Also males in the control group were generally taller than females the reverse was
seen for cleft palate groups.

11
Literature reviewed for the project shed light on the various devices and research in
the field. The research mainly pertained to feeding issues faced by the infants,
feedback of parents on various remedies used on their children. Development of
feeding plate which fits into the palate and seals off the cleft thus enabling the infant
to suck milk was discussed. Lastly the need for treatment is emphasized so that the
growth of the infant is normal.

12
 CHAPTER 3: THEORETICAL BACKGROUND

3.1 INTRODUCTION TO IMPRESSION MATERIALS

Impression materials are used to make an accurate replica of hard and soft tissue of
oral cavity. An impression is a negative replica of tissue, to take an impression the
material is carried in a tray placed in the mouth and held in place till the impression
sets. When set the impression is carefully removed from the mouth, disinfected and
stored till a cast is poured. A cast is made by filling the impression with dental stone
and allowing it to set. There are several requirements of an impression material to
produce accurate imprint of oral tissue such as:

1. It should be fluid to adapt to oral tissue.

2. It should be viscous so that it is contained in the impression trays.

3. It should have pleasant taste, odour and colour

4. It should set within a reasonable amount of time when seated in mouth.

5. The set material should remain intact or it should not distort or tear during
removal from the mouth.

6. It must be dimensionally stable till the cast is poured.

7. The material must be biocompatible

8. It should be readily disinfected without the loss of accuracy.

9. There should be no release of gas or by product during the setting of

impression and cast.

10. The material, processing time and processing equipment should be cost
effective.

11. There’s no material which can satisfy all the requirements. The choice of
particular material depends on characteristics of the tissue, environment
conditions and quality of cast required.

13
A good impression is obtained when following features are present:-

1. A homogeneous and uniform blend of impression material is evident in the

impression.

2. The material is uniformly spread over the entire tray.

3. Material should not overflow too much on the tray.

4. No tray surface visible through the impression material.

5. Details of the oral tissue and margins visible with no tears or roughness of the
margins.

6. No voids or pull on the margin details.

A cast is the positive replica of oral tissue; the steps involved in the creation of a cast
are as follows:

1. Preparation of the tray

2. Preparation and loading of the impression material into the tray

3. Making an impression

4. Removal of impression from the oral cavity

5. Disinfection of the impression

6. Preparation of the cast

3.1.1 Classification of Impression Materials

Impression materials can be classified on various parameters such as, according to

their type of reaction, their flexibility, uses etc. Which are explained below:-

1. Based on the setting mechanism

 Reversible e.g. Impression compound, dental waxes and agar

hydrocolloids

 Irreversible e.g. alginate, zinc oxide eugenol and elastomers

 Thermoset e.g. polymer and silicones

14
  Thermoplastic: These materials can be transformed from a hard solid
material into a soft mouldable material simply by raising their temperature.
This process can be reversed by cooling it to room temperature e.g.
Impression compound

2. Based on flexibility

 Inelastic or rigid materials e.g. plaster of Paris, impression compound and

zinc oxide eugenol

 Elastic e.g. elastomers, alginates and agar hydrocolloids

3. Based on amount of pressure

 Mucostatic impression material, e.g. zinc oxide eugenol impression paste

and impression plaster

 Mucocompressive impression material, e.g. impression compound and

impression waxes.

4. Based on type of tray

 Perforated metal tray- alginate hydrocolloid

 Water cooled metal tray – agar hydrocolloid

 Custom tray – zinc oxide eugenol, impression plaster and elastomeric

impression material

3.1.2 Impression compound

Impression compound is otherwise known as modelling plastic as it is thermally
reversible, rigid when cold and plastic when heated to a few degrees above mouth
temperature and hence termed as thermoplastic material.

 Composition:-

These are basically made up of thermoplastic resin and waxes, which form the
main matrix of impression compound. Compound wax is the principal
ingredient which forms the organic matrix. The natural organic compound is
gum rosin obtained from pines. Shellac, steraic acid and gutta- percha are
added which act as plasticizers. Fillers are added to provide an appropriate

15
 working consistency and strength. Talc pigments may be added to impart
colour to the impression material. Impression compound are available as
sheets, cakes, sticks or cylinders and comes in various colours such as red,
green and grey. The various colours indicate different softening and working
temperatures.

 Manipulation:-

The material being thermoplastic softens when subjected to heat. Impression

compound is softened by breaking the sheet into pieces and then placing into a hot
bowl of water at a temperature of 55 degrees Celsius to 60 degrees. The material
must not be immersed in hot water for a prolonged time because it will become
brittle as the low molecular weight compound in it gets volatised. After it is
immersed in water bath, kneading is done with fingers for 1-3 minutes to increase
the plasticity and flow of material. The compound in plastic stage is loaded on the
tray to take impression.

 Advantages:-

1. It is viscous in nature so it can be used to record the take the impression of

lingual and buccal soft tissue sufficiently.

2. It can be reused for the same patient.

3. It is economical

4. It is easy to use

5. It is non- irritant and nontoxic

 Disadvantages:-

1. Poor dimensional stability due to this significant internal stresses are

created, high coefficient of thermal expansion and poor thermal
conductivity.

2. Although theoretically the material is reversible and reused doubts have

been expressed over the ability of compound impression to survive
chemical treatments used for disinfection of impression.

16
 3. The viscosity is higher so this limits the degree of fine details which can be
recorded in an impression.

4. Compound is fairly rigid after setting and has poor elastic properties. So
while removing the impression from undercut areas distortion of
impression takes place.

 Precautions:-

The conditioning temperature and time must be controlled carefully. Since the
heat conductivity is poor it takes several minutes for the centre of material to
become softened. If the conditioning temperature is too low or the time is too
short the material does not soften properly which would not capture the details
accurately. A very high temperature and prolonged softening makes the
material sticky and difficult to manage. A long immersion time causes vital
constituent, such as steraic acid, to be leached out which leads to brittle
surface. For softening the material using direct flame skill and experience is
required because due to excessive heat it may become fluid or burn. The
material must be tempered in water bath before placing in the patient’s mouth
to lower the surface temperature or otherwise it may traumatize the oral tissue.
The relaxation of impression compound results in warpage so the material
must be completely cooled before removal from the mouth. The cast or model
should be constructed within first hour of making the impression.

3.2 DENTAL TRAYS

Dental trays or impression tray are the rigid carriers of impression material to record
the structure of oral cavity. Impression trays carry, confine and control the impression
material. These trays may be readymade or custom- made. Custom trays are tailored
to closely adapt to the patient tissue to be recorded. The various materials available
for the fabrication of custom trays are heat activated acrylic resin, chemically cured
resin and light cured resin.

1. Heat activated resin:-

These are the most widely used denture material. Conventional resin involves
the application of external heat for activation of polymerization reaction. Heat

17
 is provided from either a water bath or microwave. These resins comes in
powder/liquid system the composition of which is given in table 3.1 [13]

Table 3-1 Composition of heat activated acrylic resin

Powder/polymer Component Liquid/Monomer

Polymethylmethacrylate Major constituent Methylmethacrylate
Benzoyl peroxide Initiator -
Mercuric sulphide, cadmium Colour pigments -
sulphide
Dibutyl phthalate Plasticizer Dibutyl phthalate
Zinc oxide, titanium oxide Opacifiers -
Inhibitor
Cross-linking agent Glycol dimethylacrylate

2. Chemically cured, or self cured, PMMA is auto polymerized. The

polymerization reaction starts as soon as the powder and liquid components
are mixed together. No heat is required for the polymerization reaction to
occur so it is also called as the cold cure resin. The composition of chemically
cured resin is given in table 3.2 [13]

Table 3-2 Composition of self cure acrylic resin

Powder/Polymer Role of ingredient Liquid/Monomer

PMMA( low molecular Major component Methylmethacrylate
weight)
- Activator Dimethyl -p-toluidine
Benzoyl peroxide(5% Initiator -
w/w)
Dyed organic fillers Colour pigment -
- Inhibitor Hydroquinone

18
Chemically cured resins do not exhibit same degree of polymerization as heat cured
resins. So there is a higher level of excess monomer present in the finished product
which is the reason for poor physical and mechanical properties.

3. Light –Activated resin comes as premixed sheet or ropes in light proof

pouches. It is generally used to fabricate special trays. It’s not used for denture
bases since this technique is time consuming and cumbersome.

The various steps in the processing of different types of acrylic are explained in the
figure 3.1 [13] next page:-

19
 Creation of mold space

Application of separating
medium

Manipulation of resin

Packing of acrylic resin

Polymerization

Heat activated Light activated Light activated

Sprinkle on
Compression molding technique

Hand adapted
Injection molding dough technique

Compression
molding technique

Fluid/pour

Figure 3.1 Steps in the processing of acrylic materials

20
 CHAPTER 4: DENTAL TRAYS DESIGN

4.1 DATA COLLECTION

 Eight Cast samples of newborn babies suffering from right cleft were procured
from Govt Dental College, Nagpur. The Cast is positive replica of upper palate
and is made by filling the impression with dental stone and allowing it to set.

Figure 4.1POP samples of right cleft of 8 newborns

 On consultation with Dr. Kalaskar, the various critical dimensions on palate

are identified as maximum lateral dimension, anterior-posterior distance, max
depth of cleft, width of cleft and distance of the cleft from lateral points
accordingly points are marked on all the samples. Lateral dimension defines
the size of the tray, anterior posterior dimension indicates the jaw size and the
depth of cleft is needed so that impression material flows to get the impression
till max depth.

21
 Posterior point
Lateral points
Alveolar ridge

Cleft
Anterior point

Figure 4.2 Critical points

 So 30 critical coordinates were marked on each of the 8 samples

 After this cloud point data was generated using Mitutoyo CMM by following
these steps:-

1. Prior to experimentation a common path was determined to be followed by

2mm diameter probe for all the samples.

2. Reference plane was selected and origin of the work piece is aligned with
the origin of CMM.

3. Element option point was selected and points probed on the work piece
according to the path decided.

4. Output generated in excel format.

22
 Figure 4.3 Use of CMM

Figure 4.4 Point Cloud Data

23
4.2 SOFTWARE MODEL OF TRAY
The three dimensional coordinates so obtained were averaged in Excel to get the
cloud of 30 average coordinates

Figure 4.5 Point Coordinates

 This cloud is imported to solid works using add- in Scanto3D and model of
palate was made using boundary surface tool

Figure 4.6 Point Cloud in Solidworks

24
 Figure 4.7 Surface model of palate

 The palate model thus generated was used to design the contour of dental tray

 Wall was added to prevent the impression material from leaving the tray and
with the addition of handle the surface model is complete.

 The model surfaces were thickened by 2.5mm for fabrication purpose so that
while processing acrylic material shrinkage will be minimum [13].

25
 Figure 4.8 CAD model of Dental Tray

4.3 RP MODEL OF TRAY

 Solidworks part file was converted to printable STreoLithography (STL)

format and RP model of tray was printed in Acrylonitrile-Butadiene-Styrene
(ABS) material.

Figure 4.9 Stratasys 3D Printer

26
  RP model is obtained by removing the support structure by using Solvent-
Ecowork.

Figure 4.10 RP of the Dental Tray

 The RP model was shown to the dentist and the design was finalised.

4.4 SIZING OF DENTAL TRAYS

There is difference in facial structure of each individual. Two babies of exactly the
same age may have different jaw sizes so small tray may be suitable for one child and
and a much larger for another.

Different trays are also needed because patient is in growing stage during the period
of one month to sixth month. So a single tray was not sufficient to take the
impressions for patients of different oral anatomy and age groups.

This resulted in the need of designing a set of dental trays and not just an individual
tray. Based on his experience Dr Kalaskar had identified that growth mainly takes
place along the lateral and anterior directions. So the design of new trays involved the
application of scaling factor to already designed trays in order to generate a set of
trays to be used by pediatric dentist.

27
The dental trays are numbered as Tray 0, Tray 1, Tray 2 and Tray 3 in the increasing
order of their sizes. The tray designed by average coordinates is the Tray1. Tray 0 was
obtained by scaling down Tray 1. Tray 2 and Tray 3 were obtained by scaling up Tray
1.

Both the largest lateral dimension and anterior to posterior distance are increased by
approximately 5mm along the coordinate axes in subsequent trays. The posterior
point was chosen as the origin and all scaling was done using origin as reference.

For Tray 1;

Largest lateral distance = 43 mm

Anterior to posterior distance= 32mm

So the dimensions of other three dental trays are defined as:

Tray 0;

Largest lateral distance = 38

Anterior to posterior distance= 27mm

Tray 2;

Largest lateral distance = 48 mm

Anterior to posterior distance= 37 mm

Tray 3;

Largest lateral distance = 53 mm

Anterior to posterior distance= 42 mm

The largest lateral dimension in Solidworks software is along the x axis and anterior
to posterior is along y axis. Hence scaling factor was determined with respect to tray 1
for each tray in x-y direction.

Tray 0;

Kx=38/43=.8837
Ky= 27/32= .8437

Tray 2;

28
Kx=48/43=1.1163
Ky=37/32= 1.1562

Tray 3;

Kx= 53/43= 1.2325

Ky= 42/32= 1.3125

Using scale command in Solidworks Features Toolbar, the calculated scaling factors
were entered. Scaling factor in z direction was entered as 1. Solid model of Tray 0,
Tray 2 and Tray 3 were generated.

Figure 4.11 Scaling to Tray 2

29
 CHAPTER 5: DEVELOPMENT OF TRAYS

5.1 MATERIAL SELECTION

Heat activated acrylic resin was selected as the material of tray because of because of
its adequate mechanical and esthetic properties. It consisted of polymer
Polymethylmethacrylate (PMMA) in powder form and Methylmethacrylate monomer
in liquid form.

5.2 FABRICATION OF TRAYS

The trays were fabricated at Government Dental College Nagpur in Prosthetics lab.
The procedure followed consisted of the following steps:-

1. Mould space was created using Acrylonitrile-Butadiene-Styrene as the pattern

in gypsum. Gaps in the pattern were filled using wax by applying it on the
surface other side of loading the impression compound. So that the profile of
the surface on which the impression compound is to be loaded does not
change. The extra material due to application of wax was removed during
finishing operation.

Figure 5.1 Two sides of RP tray

30
 Figure 5.2 Gypsum Mould

2. Two coats of separating media sodium alginate were applied on the gypsum
mould so that water from the gypsum does not enter the resin and monomer
does not enter the gypsum.

Figure 5.3 Separating media applied

31
3. Acrylic dough was prepared by mixing polymer Polymethylmethacrylate
(PMMA) and monomer Methylmethacrylate in the ratio 3.5/1 by volume and
then the mixture was left for 15 minutes to attain dough like consistency.

Figure 5.4 Acrylic dough

4. After the mixture attained dough like consistency it was packed into the mould
space in the dental flask. Right amount of material was placed in the flask by
repeatedly opening and closing the dental flask in stages by gradually
increasing the closure pressure. After all the flash is removed the flask was
closed under pressure in a flask clamp.

Figure 5.5 Mould space filled with acrylic resin

32
 Figure 5.6 Excess flash removals
5. The flask was placed in the boiling water bath for one hour to complete the
curing cycle. After that it was allowed to cool for one hour and the acrylic tray
was taken out by opening the flask.

Figure 5.7 Flask containing Tray

33
 Figure 5.8 Acrylic Tray with flash and gypsum

6. The tray obtained was finished in two steps trimming and sand papering to
remove the acrylic flashes and gypsum sticking to it. Initial trimming was
done by carbide burr and then sand paper was the used to remove all the
scratches on the surface.

Figure 5.9 Finishing kit & Trimming of Tray

7. Acrylic tray is obtained which can be used for clinical trials on patients.

34
 CHAPTER 6: RESULTS AND CONCLUSION

6.1 Results and Conclusion

New and improved method of taking accurate palate impressions was invented using
data available at GDC, Nagpur

Dental Trays were designed in 4 standard sizes after extensive consultation with
doctors to conform to patients having different facial anatomy, age and nature of cleft

Dental Trays were fabricated in acrylic hot cure resin at GDC, Nagpur

Figure 6.1 Acrylic Tray 1

35
 CHAPTER 7: Future Scope

In the current project, the aim was to design and develop Dental Trays for cleft
palate babies. While that objective has been fulfilled, it is now important to check the
validity of Dental Trays so clinical trials on cleft patients need to be done.

1. Clinical Trials of Dental Tray Set

First is by comparing the anatomical resemblance of impression obtained

by hand versus that taken using dental tray.
Secondly, anxiety levels of the practicing dentist can be compared in both
situations by measuring the heart rate while taking the impression.

2. Extending Application of Dental Trays to Left Cleft and Bilateral Cleft

Patients

The process discussed in this project may be repeated for design and
development of dental trays for left cleft and bilateral cleft patients if
sufficient no of samples are procured.

36
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