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SYNOPSIS FOR MAIN DISSERTATION

KARNAVATI SCHOOL OF DENTISTRY

Comparison Of Primary Molar Crown Dimensions


With Stainless Steel Crowns In A Sample Of
1. Title of the topic Indian Children A Cross Sectional Study.

2. Name of the Post Dr. Aayushi U. Vithalani


graduate student

Department of Pedodontics & Preventive Dentistry

3. Department of the Karnavati School of Dentistry


student

4. Batch of the student 2015 2018

5. Year 1st Year MDS

6. Name of the Guide& Dr. Shital Kiran D.P.


Co-investigator

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CONTENT

Sr. No. TOPICS Page No

1 Introduction 3

2 Aim and Objectives 4

3 Review of literature 5

4 Materials and methods 8

5 Statistical method 21

6 Proforma for collection of data 22

7 Ethical issues 23

8 Feasibility issues 24

9 Likely outcomes / Benefits of study 25

10 Conflict of interest 26

11 Sponsors of the study, If any 27

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12 Source of fund, If any 28

13 Expenditure statement 29

14 References 30

15 Signature of Principal Investigator & Co- 30


Investigator

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INTRODUCTION :

Development of dentition is one the most integral part of physiologic and


psychologic development of any person. Attempt to maintain the primary teeth
until the eruption of their permanent successors have resulted in the introduction
of many semi-permanent restorations.1, 2 Humphrey introduced Stainless steel
crowns (SSCs) to pediatric dentistry in 1950.3 Different SSCs in terms of size,
shape and contour (festooned) have been introduced to the dental market by
different manufacturers.

Selection of an appropriate SSC, in terms of marginal adaptation and proximal


fit, has always been challenging for clinicians particularly pedodontists.4

The tooth size discrepancy in different populations and ethnic groups is an


important issue in this respect that needs to be taken into account. Such
differences in some cases are significant.5-7 Primary molars have had variations
in size and the primary first molar crown has shown the widest variations in
dimensions (primary second molar has had the smallest variations). Evaluations
of tooth dimensions in different ethnicities and genders just show the
differences in tooth size.

In this study, mesiodistal (MD) and buccolingual (BL) dimensions of the


primary molar teeth in the Indian population will be assessed for the newly
introduced Hu Friedy stainless steel crown in Indian market.

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AIM AND OBJECTIVES

Aim:

To compare the primary molar crown dimensions with Hu Friedy stainless steel
crowns in Indian population.

Objectives:

To measure the mesiodistal and buccolingual dimensions of the upper and


lower first molars and to compare with the preformed Hu Friedy crowns.

To measure the mesiodistal and buccolingual dimensions of the upper and


lower second molars and to compare with the preformed Hu Friedy
crowns.

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REVIEW OF LITERATURE:

1. Hossein Afshar, Arghavan Kamali Sabeli, Mahdi Shahrabi (2015)8


conducted a study to compare the primary molar crown dimensions with
stainless steel crowns in a sample of Iranian children. Impressions were
taken and the casts were poured wherein 216 primary molars were selected
and which was divided into 4 groups of 54. The mesiodistal and the
buccolingual dimension of lower first molar stainless steel crown had least
difference with the corresponding values of respective teeth. The mesiodistal
and buccolingual dimension of upper second molars stainless steel crown
had the greatest difference with the corresponding value of the respective
teeth. Therefore the authors concluded that best adaptation was seen in the
lower second molars and least adaptation in first and second upper molars.

2. E. Barberia, M.C. Suarez, G. Villalon, M. Maroto, F. Gracia - Godoy


(2009)9 carried out a study to obtain mesiodistal, buccolingual and height
sizes of dental crowns of first and second primary molars in a sample of
Spanish children. Measurements were made on dental plaster models of 703
selected patients primary molars which were divided into 401 second
molars and 302 first molars. Primary second molars had less variability than
first molars in aspect of mesiodistal, buccolingual and height dimensions.
Lower first molars had less variability than upper first molars, in regard to
mesiodistal and buccolingual sizes, but were more variable in height. Lower
second molars were also less variable than upper second molars in regard to

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mesiodistal size. The measurement with the least variability was height,
followed by mesiodistal size. An exception was that of boys lower first
molars, in which height was more variable than mesiodistal distance.

3. Karteek Eswara, Jogender Sai Sankar Avula, George Manoj Kumar


Mallela, Sreedevi Enuganti, Jai Sankar Pratap Gowd Margana,
Pranitha Kakarla (2014)10 performed a study to obtain crown dimensions
of primary molars in a sample of 4 9 years South Indian children who were
randomly selected. Impressions were taken and the casts were poured
wherein 100 primary molar casts were selected. Primary first molars had less
variability than second molars. Mesiodistal dimension showed less
variability than buccolingual dimension.

4. Joycelyn Eigbobo, Elizabeth Sote, Folakemi Oredugba (2010)11 studied


odontometric information in three dimensions: mesiodistal, buccolingual and
clinical height of the crown of primary molars of 3 5 year old Nigerian
children. Alginate impressions were taken of 400 children and casts were
poured and 8000 teeth were measured. The largest mean mesiodistal
dimension was of mandibular primary second molar. The maxillary second
molar had the largest buccolingual dimension. The males had larger mean
tooth dimensions in most tooth types. They have also concluded that
Nigerians have larger primary tooth dimensions than Caucasians, Jordanians,
Taiwanese and smaller primary ttoth dimensions than Australian Aborigines
but comparable to those of Indians.

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5. Keith K.W. Yuen, Lisa L.Y. So, Endarra L.K. Tang (1997)12 measured
mesiodistal crown diameters of primary and permanent teeth in Southern
Chinese population. The sample consisted of 112 (61 males and 51 females)
Chinese children dental casts and teeth were examined. Posterior teeth were
generally less variable than anterior teeth in both dentitions. Male teeth were
larger than those of females, except lower central and lateral incisor in both
dentitions.

6. Axelsson G., Kirveskari P. (1984)13 evaluated crown size of deciduous


teeth in Icelanders. Mesiodistal and buccolingual crown diameters of
deciduous teeth were measured from dental casts of 540 children and found
crown index showed little sexual dismorphism in boys than in girls. The
crown module was consistently larger in boys than girls.

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MATERIALS AND METHODS

A. STUDY DESIGN

A cross sectional study

i. PLACE OF STUDY: Department of Pedodontics and Preventive


Dentistry, Karnavati School of Dentistry, Gandhinagar, Gujarat.

ii. SOURCE OF DATA : Children who are accompanied by parents,


guardian, care taker or next to their kin reporting to the OPD of
Department of pedodontics and preventive dentistry, karnavati school of
dentistry, Gandhinagar, Gujarat.

iii. RELATED APPROVALS : Prior written informed consent will be


obtained from the parents of the selected children for the study

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iv. SAMPLE DESCRIPTION

Minimum sample size required for the statistically significant result is determined using desired
formula:
Sample size= 2*(Zalfa/2 +Z1-beta)^2/ (m1-m2/sigma)^2

Where Zalfa/2=1.96
Z1-beta=1.64
m1= mean of group 1=-0.0491
m2= mean of group 2=-0.1869
sigma= standard deviation=0.33

So final sample size is 150. Per group sample size is 75.

TIME SCALE OF STUDY :

2. years

v. SELECTION CRITERIA

A) Inclusion criteria :

1. Children aged between 0-14 years.

2. Children whose parents will give written consent for the study.

3. Healthy maxillary and/or mandibular first and/or second molars.

4. Healthy child free from any systemic disease.

B) Exclusion criteria:

1. Children with caries maxillary and/or mandibular first and/or second


molars.

2. Children with restoration of maxillary and/or mandibular first and/or


second molars.

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3. Maxillary and/or mandibular first and/or second molars having
anomalies.

4. Children with systemic disease.

5. Children whose parents refuse to give the written consent.

vi. MATERIALS AND EQUIPMENTS FOR THE STUDY

INSTRUMENTS:

1. Perforated trays

2. Diagnostic instruments

3. Green cloth

4. Kidney trays

5. Digital caliper

MATERIALS:

1. Gloves

2. Masks

3. Head capes

4. Cotton

5. Alginate

6. Dental stone

B METHODOLOGY :

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The proposed study will be conducted as a cross sectional design. Prior written permission
and consent will be obtained from the participants parents.

After considering all the inclusion and exclusion criterias, a total of 150 participants will be
selected for the study. The sample size will further be divided into 75 maxillary and 75
mandibular molars each.

All the participants will be roughly examined by the principle investigator and the children
who meet the requirements, after obtaining the informed consent, alginate impressions will be
made for the maxillary and/or mandibular arches of the selected patients. Impressions will be
poured using dental stone. Then using caliberated digital caliper, primary upper and lower first
and second molar crown dimensions will be assessed and compared with the mesiodistal and
buccolingual dimensions of Hu Friedy stainless steel crowns with a precision of 0.001 mm.

The greatest distance between the midpoints of the mesial and distal marginal ridges will be
measured as the MD dimension of each tooth. To determine the BL dimension, the greatest BL
dimension at the free gingival margin will be measured. The MD and BL dimensions of each
tooth will be measured twice and the mean of the two values will be recorded as the final value.
For measuring the dimensions of SSCs, numbers 2-7 of Ni-Chro (Ion) SSCs of each tooth in
the right and left quadrants (Hu - Friedy) will be selected. The MD dimension of SSCs will be
measured as in the teeth (the greatest distance between the midpoints of the mesial and distal
marginal ridges). For the measurement of BL dimension, it will be done from the base of the
SSC margin.

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KARNAVATI SCHOOL OF DENTISTRY

CONSENT FORM FOR PARTICIPANTS PARENTS

STUDY TITLE: Comparison of Primary Molar Crown Dimensions with


Stainless Steel Crowns In A Sample of Indian Children A Cross Sectional
Study.

Study Number: ________________________ Date of Birth / Age _________ (Years)

1. I/we confirm that I/we have been informed about the making of alginate impressions
for the study purpose of comparison of primary molar crowns with stainless steel
crowns. [ ]

2. I/we confirm that I/we have read and understood the information sheet dated
_________for the above study. [ ]

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3. I/we understand that my childs participation in the study is voluntary and that I/we
are free to withdraw at any time, without giving any reason, without my medical
care or legal rights being affected. [ ]

4. I/we understand that my childs identity will not be revealed in any information
related to third party or published. [ ]

5. I/we agree not to restrict the use of any data or results that arise from this study
provided such a use is only for scientific purpose(s). [ ]

6. I/we allow our child to take part in the above study. [ ]

Signature of the participant/Guardian_______________________________

Signatorys Name ______________________________________ Date _______________

Signature of the investigator ______________________________

Investigators Name_______________________________ Date ___________

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KARNAVATI SCHOOL OF DENTISTRY

PARTICIPANTS PARENTS INFORMATION SHEET

STUDY TITLE: Comparison of Primary Molar Crown Dimensions with


Stainless Steel Crowns In A Sample of Indian Children A Cross Sectional
Study.
Study No. _______________________ Date ___________________

Dear participants parents,

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1. For the study purpose, primary upper and lower molar crown dimensions and its
comparison with Hu- Friedy stainless steel crowns, alginate impressions will be made
of your childs upper and/or lower arches.

2. We consider your opinion to be very important.

3. We assure you that your information will be kept confidential and used only for research
purposes.

4. If you have any doubts, queries and/or complaints related to the study you can contact
Dr. Aayushi U. Vithalani, Department of Pedodontics And Preventive Dentistry,
Karnavati School of Dentistry, Uvarsad, Gandhinagar.

Contact details: +919879440106; email: aayushi.vithalani@gmail.com

Sign of investigator_____________________________

Sign of participants/Parent________________________

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: +919879440106; : aayushi.vithalani@gmail.com

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_____________________________

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KARNAVATI SCHOOL OF DENTISTRY

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PARTICIPANTS ASSENT FORM
STUDY TITLE:
Comparison of Primary Molar Crown Dimensions with Stainless Steel Crowns
In A Sample of Indian Children A Cross Sectional Study.

Dear participant,

1. For the study purpose, primary upper and lower molar crown dimensions and its
comparison with Hu- Friedy stainless steel crowns, alginate impressions will be made
of your upper and/or lower arches.

2. We consider your opinion to be very important.

3. We assure you that your information will be kept confidential and used only for research
purposes.

4. If you have any doubts, queries and/or complaints related to the study you can contact
Dr. Aayushi U. Vithalani, Department of Pedodontics And Preventive Dentistry,
Karnavati School of Dentistry, Uvarsad, Gandhinagar.

Contact details: +919879440106; email: aayushi.vithalani@gmail.com

Sign of investigator_____________________________

Sign of participant ______________________________

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: -

, -
/

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2.

3.

4. , , , ,
, /

: +919879440106; : aayushi.vithalani@gmail.com

______________________________

_______________________________

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: +919879440106; : aayushi.vithalani@gmail.com

______________________________

_____________________________

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STATISTICAL METHODS

The collected data will be entered SPSS 18.0 version. Descriptive statistical tests will be
computed using excel statistical operations. Inferential statistics will be done using SPSS 18.0
version. Suitable statistical tests will be applied.

Statistical test to be applied is:

Independent sample T test

One way ANOVA

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PROFORMA FOR COLLECTION OF DATA:

Serial No. : _________

Date: ____________

Name: _____________________

Age/sex: ____________________

Case No.: ______________

Address: ____________________

MD BL
MD BL
DIMENSIONS DIMENSIONS
TOOTH DIMENSIONS DIMENSIONS
OF PATIENTS OF PATIENTS
OF SSC OF SSC
CAST CAST

Maxillary first molar

Maxillary second
molar

Mandibular first
molar

Mandibular second
molar

Signature of Principal Investigator_________________________


Signature of Co-Investigator______________________________

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ETHICAL ISSUES :
The confidentiality of the participants will be maintained and the information will not
be disclosed to anyone.

Participant will be allowed to leave this study anytime.

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FEASIBILITY ISSUES :

All the participants will be selected in the given time period.

Principle investigator will buy Hu Friedy stainless steel crown in


advance.

All funding will be done by the principal investigator.

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LIKELY OUTCOME/BENEFITS OF STUDY :

This study will contribute to matching ability of Hu Friedy crown with the
crown dimensions in Indian population.

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CONFLICT OF INTEREST :

Nil

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SPONSERS FOR THE STUDY

No fund/sponsorship will be taken from any company/firm/institutions.

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SOURCE OF FUNDS

Funding will be done by the principal investigator herself.

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EXPENDITURE STATMENT:

The expenditure would be approximately as follows:-

Hu Friedy upper and lower first and second molar crowns of all sizes - 11,000

Digital caliper 1500

Gloves 500

Masks 200

Dental stone 600

Alginate 1000

Diagnostic set - 500

Biostatistician cost - 2500

Total 17,500

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REFERENCES
1) Hossein Afshar1, Arghavan Kamali Sabeti, Mahdi Shahrabi. Comparison
of Primary Molar Crown Dimensions with Stainless Steel Crowns in a
Sample of Iranian Children. J Dent Res Dent Clin Dent Prospect 2015;
9(2):86-9.

2) E. Barbera, M.C. Surez, G. Villaln, M. Maroto, F. Garca-Godoy.


Standards for mesiodistal and buccolingual crown size and height of
primary molars in a sample of Spanish children. European Journal of
Paediatric Dentistry 2009; 10(4): 169-175.

3) Karteek Eswara, Jogender Sai Sankar Avula, George Manoj Kumar


Mallela, Sreedevi Enuganti, Jai Shankar Pratap Gowd Margana, Pranitha
Kakarla. Deciduous molar sizes and sexual dimorphism: South Indian
study. Journal of Pediatric Dentistry 2014; 2(1): 13-19

4) Joycelyn Eigbobo1, Elizabeth Sote2, Folakemi Oredugba. Tooth Crown


Dimensions of Dentitions in the Nigerian Population. Acta Stomatol
Croat. 2010; 44(4):269-277.

5) Keith K. W. Yuen, Lisa L. Y. So, Endarra L. K. Tang. Mesiodistal crown


diameters of the primary and permanent teeth in Southern Chinese-a
longitudinal study. European Journal of Orthodontics 1997; 19: 721-731.

6) Axelsson G, Kirveskari P. Crown size of deciduous teeth in Icelanders.


Acta Odontol Scand 1984; 42: 339-343.

Signature of Principal Investigator: ___________________

Signature of Co-investigator/PG Guide: ___________________

DATE:

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PLACE:

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