RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE

KARNATAKA

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1 / Name of the candidate and address / DR. CHANDAN KAUR SARANG
MARATHA MANDAL’S
NATHAJIRAO G. HALGEKAR INSTITUTE OF DENTAL SCIENCES & RESEARCH CENTRE, BELGAUM-590010
2 / Name of the institution / MARATHA MANDAL’S
NATHAJIRAO G. HALGEKAR INSTITUTE OF DENTAL SCIENCES & RESEARCH CENTRE, BELGAUM-590010
3 / Course of the study and subject / MASTER OF DENTAL SURGERY
ORAL MEDICINE AND RADIOLOGY
4 / Date of admission / 01.08.2013
5 / Title of the topic / “ADULT AGE ESTIMATION BY EVALUATING PULP CHAMBER CROWN ROOT TRUNK HEIGHT RATIO USING MANDIBULAR FIRST MOLAR - A PANORAMIC STUDY”
6 / Brief resume of intended work
6.1. Need for the study
Age estimation has application both in post mortem identification as well as in living individuals in whom chronological age is under dispute. 1 When different parts of the body used for age estimation were compared, tooth was found to be the most durable and least affected by post- mortem changes 2
Changes that are appreciable in teeth with increasing age are attrition, periodontal disease, secondary dentin deposition, root translucency, cementum apposition, root resorption, colour changes and increasing root roughness. By taking into account these changes in the teeth various studies have been done to estimate the age.3
After root completion; secondary dentin is deposited throughout one's life reducing the pulp chamber. This reduction in pulp chamber was correlated with chronological age2. Regression equations were derived using pulp tooth area ratio to estimate the age in Cameriere’s method and Kvaal’s. However , most of the current age estimation techniques developed for Indian population use anterior teeth .2
So, Mathew et al. (2013) devised a novel radiographic technique of adult age estimation using pulp chamber crown root trunk height ratio in mandibular first molar with acceptable error margins for forensic age estimation. Hence, the purpose of this study is to know if above method can be adapted to Belgaum population for optimal age prediction.

6.2. Review of literature :
Rai B. and Anand S. (2006) conducted a study to determine the accuracy of five methods of age estimation i.e. Demirijian’s , Nolla, Haavikko, Williams and Cameriere method using developing teeth from OPGs of 75 subjects between 5-14 years of age. They found the Williams method to be the most accurate followed by Haavikko, Cameriere, Nollas and lastly Demirijian’s method. 3
El- Bakaray, Hammad S., Ibrahim F. (2009) made a comparison between Willems and Cameriere’s method of age estimation among the Egyptian children using 286 digital OPGs between the age group of 5-16 years Significant positive correlation between age estimated by both methods and chronological age was observed. However, Willems (98.62%) method was slightly more accurate than the Cameriere’s (98.02%) method. Nevertheless they recommended both for practical application in clinical dentistry .4
Aggarwal N., Ahuja P., Sinha A., Singh A.(2012) presented a method for assessing the chronological age based on relationship between the age and morphological parameters of maxillary central incisors. IOPAs of fully erupted right maxillary central incisors were taken using paralleling technique. The length of tooth, pulp, root and width of root and pulp were measured at three different points. Regression formulas were used to calculate the dental age. The mean estimated age showed no statistically significant difference from actual mean age. Therefore, it was concluded that maxillary central incisor proved to be significant indicator of chronological age.5
Mathew D., Rajesh S., Koshi E., Priya L. ,Nair A., Mohan A. ( 2013) developed an independent procedure to estimate age in adults using the ratio of pulp chamber height to the crown height in mandibular first molar. Digitalized OPG of 60 subjects between 20-60 years were used to derive regression formula to calculate the age wherein
Estimated age = -100.920(PCTHR) + 55.415.
The accuracy of the formula was tested in 28 subjects They found the method to be fairly accurate to perform forensic age prediction in Indian individuals with acceptable error margins (±10 years)2
6.3 / Objectives of the study :
1.  To measure Pulp Chamber Crown Root Trunk Height Ratio (PCTHR) of mandibular first molar by dividing pulp chamber height (PCH) by crown root trunk height (CRTH).
2.  Estimate age for Belgaum population (in age range of 20-40 years) using PCTHR.
3.  To check the difference between chronological age and estimated age and to know the age prediction success of the above method.
Materials and Methods
7.1.Source of data-
The subjects for the study will be selected by employing convenience and judgmental sampling method among patients reporting to the Department of Oral Medicine and Radiology, Maratha Mandal Dental College., Belgaum
This study will include observation and analysis of digital panoramic radiographs of 60 patients.
Materials:
a) Digital panoramic system : Kodak 8000C, Eastman Kodak company
b) Masterview 4.5.3 beta version software
c) Sterilized lead foils folded in pellet form and secured by dental floss.
Method of collection of data
INCLUSION CRITERIA
1) Age-20-40 years including both males and females
2) Presence of left mandibular first molar.
EXCLUSION CRITERIA
When the left mandibular first molar is affected by any of the following conditions-
1)  Developmental anomalies, pathologies like caries , moderate to severe attrition and cervical abrasion, occlusal facets, periodontitis or periapical pathology, or any restoration /RCT.
2)  Grossly malpositioned /tilted tooth
3)  Absence of antagonistic teeth.
4) Overlapping of the roots in furcation area in O.P.G.
PROCEDURE
An approval from the ethical committee of the institute shall be obtained prior to the beginning of the study and all the participants will be given brief information regarding the purpose of the study. Written consent will be taken from willing subjects before undertaking the study. Sterilized lead foils folded to form pellets and secured by dental floss will be adapted to the occlusal surface of left mandibular first molar in order to better localize the central fossa in the O.P.G. The distance between central fossa and the highest point of root furcation (CRT) and the distance between roof and floor of pulp chamber (PCH) will be measured. Measurements will be done by two observers independently using Masterview 4.5.3 beta version software. All data will be recorded in Microsoft excel spread sheet.
PCTHR will be calculated (PCTHR = PCH/CRTH). Age will be estimated by using the formula; estimated age = -100.920(PCTHR) + 55.415
STATISTICAL ANALYSIS
The data obtained will be statistically analyzed using the following -
1)  Pearson’s correlation coefficient
2)  Linear regression analysis
3)  Kappa statistics
4)  Unpaired t-test
7.3. Does the study require any investigation or interventions to be conducted on patients or other humans or animals? If so, please describe briefly. / Yes, digital orthopantomographs will be taken
7.4. Has ethical clearance been obtained from your institution in case of 7.3? /
YES
8.References
1. Acharya A., Sivapathasundharam B., Forensic Odontology in R. Rajendran , B. Sivapathasundaram, Textbook of Oral Pathology , 6th edition 2009; 871-99
2. Mathew D. Rajesh S., Koshi E., Priya L. ,Nair A., Mohan A. Adult forensic age estimation using mandibular first molar radiographs: A novel technique. J of forensic dental sciences 2013; 5( 1):56-59
3. Rai B. and Anand S. Tooth developments-An accuracy of age estimation of radiographic methods: World Journal of Medical Sciences 2006; 1(2):130-32
4. El- Bakaray Hammad S. Ibrahim F.-Comparison between two methods of dental age estimation among Egyptian children - Mansoura J.Forensic Med Clinical Toxicol 2009;17(.1 ):75-86
5. Aggarwal N., Ahuja P., Sinha A., Singh A. Age estimation using maxillary central incisors: A radiographic study. Journal of Forensic Dental Sciences 2012; 4( 2) :97-100
9 / Signature of candidate
10 / Remarks of the guide
11 / Name and designation ( in block letter)
11.1. Guide / DR. PRAVEENA TANTRADI
ASSOCIATE PROFESSOR,
DEPT. OF ORAL MEDICINE AND RADIOLOGY
MARATHA MANDAL’S
N.G.H.I.D.S. & R.C. BELGAUM-590010
11.2. Signature
11.3 Co-guide
11.4. Signature
11.5 Head of the department / DR. RENUKA AMMANAGI
PROFESSOR & HEAD
MARATHA MANDAL’S
N.G.H.I.D.S. & R.C. BELGAUM-590010
11.6. Signature
12 / 12.1. Remarks of the Principal
12.2. Signature


MARATHA MANDAL’S NGH INSTITUE OF

DENTAL SCIENCES AND RESEARCH CENTRE, BELGAUM

R. S. No. 47A/2, Bauxite Road, BELGAUM - 590 010. Phone No. 2477682

INFORMED CONSENT FORM

This Informed Consent Form is for individuals aged between 20-40 years willing to participate in the research project titled Adult age estimation by evaluating pulp chamber crown root trunk height ratio using mandibular first molar- a panoramic study

Name of Principal Investigator: Dr. Chandan Kaur Sarang

Name of Organization: MARATHA MANDAL’S NGH INSTITUE OF DENTAL SCIENCES AND RESEARCH CENTRE, BELGAUM.

This Informed Consent Form has two parts:

I.  Information Sheet (to share information about the study with you)

II.  Certificate of Consent (for signatures if you agree to take part)

You will be given a copy of the full Informed Consent Form

PART I: Information Sheet

Introduction

I, Dr. Chandan Kaur Sarang am doing my Post graduation in Oral Medicine and Radiology. I am doing a research on Adult age estimation by evaluating pulp chamber crown root trunk height ratio using mandibular first molar- a panoramic study. I am going to give you information and invite you to be part of this research. You do not have to decide today whether or not you will participate in the research. Before you decide, you can talk to anyone you feel comfortable with about the research. I assure you that if you do not understand some of the words or concepts, I will take time to explain them you may ask questions now or later.

Purpose of the research

Age estimation is of wide importance for legal purposes and also for forensic investigations. The purpose of conducting this study is to estimate the age in adults using panoramic radiographs.

Type of Research Intervention

This research will involve case history recording, examination of oral cavity and later a digital panoramic radiograph (O.P.G.) with lead foil adapted to the occlusal surface of left mandibular first molar will be taken.

Participant selection

I wish to include individuals in the age group of 20-40 years and having left mandibular first molar. Individuals in which the left mandibular molar is unaffected by developmental anomalies, pathologies like caries, periodontitis or periapical pathology or any restoration /RCT will be included in the research.

Voluntary Participation

Your participation in this research is entirely voluntary. It is your choice whether to participate or not. Whether you choose to participate or not, all the services you receive at this institute will continue and nothing will change.

Procedures and Protocol

After screening examination is done and if you fulfill the selection criteria you will be invited to participate in the research. If you are willing to participate in the research, a sterilized lead foil folded to form a pellet, secured by dental floss will be adapted on to your first mandibular molar and an O.P.G. will be taken.

Duration

The procedure involves a single visit wherein case history proforma will be filled, oral cavity screening will be done and later digital O.P.G. will be taken. The entire procedure may require about 30 minutes.

Side Effects

No side effects

Risks

There is no risk of any kind to your health. The x-ray exposure is equivalent to 1-3 days of background exposure.

Benefits

There may not be any benefits for you but your participation is likely to help us find the answer to the research question.

Reimbursements

You will not be charged for the digital O.P.G. which will be taken as a part of the study. Other than this you will not be given any other money or gifts to take part in the research.

Confidentiality

I assure you the personal information collected from you will be kept confidential.

Sharing the results

The findings of this study will be shared broadly through publications and conferences. However confidential personal information will not be shared. The knowledge that we get from doing this research will be shared with you.

Right to refuse or withdraw

You do not have to take part in this research if you don’t wish to do so. Choosing to participate or not will not affect your future treatment at the Centre here in any way. You will still have all the benefits that would otherwise be available at this Centre.

Who to Contact

If you have any questions you may ask them now or later. If you wish to ask questions later, you may contact the following:

Dr Chandan Kaur Sarang Contact No. 9739421883

This proposal has been reviewed and approved by ethical committee of the Maratha Mandal’s N.G.R.H. institute and research centre of dental sciences which is a committee whose task is to make sure that research participants are protected from harm.

PART II: Certificate of Consent

Certificate of Consent

I have been asked to give consent to participate in this study which will involve a radiographic procedure. I have read the foregoing information. I have had the opportunity to ask questions about it and any questions that I have asked have been answered to my satisfaction. I consent voluntarily to participate in this study.

Name of Participant______

Signature of Participant______

Date ______(Day/month/year )

If illiterate

I have witnessed the accurate reading of the consent form to the potential participant, and the individual has had the opportunity to ask questions. I confirm that the individual has given consent freely.

Name of witness______ AND Thumb print of participant

Signature of witness ______

Date ______

Day/month/year

Statement by the researcher/person taking consent

I have accurately read out the information sheet to the potential participant, and to thebest of my ability made sure that the participant understands that the following will be done:

1. Detailed case history of the participant will be recorded.

2. Sterilized lead foil secured with a dental floss will be adapted on to the occlusal surface of mandibular first molar.