RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA, BANGALORE

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1.Name of the candidate and address(In block address)

Dr. ROHAN.S, POST GRADUATE STUDENT,PLOT NO 9,18TH A CROSS 8TH MAIN BANDAPPA GARDEN EXTENTION, MUTHYALANAGAR GOKUL POST, BANGALORE-560054

2. Name of the institutionTHE OXFORD DENTAL COLLEGE, HOSPITAL& RESEARCH CENTRE, BANGALORE.

3. Course of study and subject MASTER OF DENTAL SURGERY, PERIODONTICS

4. Date of admission to course 25 MAY, 2012

5. Title of the Topic EVALUATION OF PERI-IMPLANT TISSUES IN SUBJECTS WITH VARYING GINGIVAL BIOTYPE WITH AND WITHOUT PLATFORM SWITCHING-A CLINICAL AND RADIOGRAPHIC STUDY

9. SIGNATURE OF THE CANDIDATE

10. REMARKS OF THE GUIDE

11. 11.1 NAME AND DESIGNATION OF

THE GUIDE

Dr. A.V. RAMESH

PROFESSOR AND HOD

DEPARTMENT OF PERIODONTICS

SIGNATURE OF THE GUIDE

11.2 CO-GUIDE Dr. SANJAY MOHANCHANDRA

PROFESSOR AND HOD

DEPARTMENT OF IMPLANTOLOGY

SIGNATURE OF THE CO-GUIDE

11.2 HEAD OF THE DEPARTMENT

Dr. A.V. RAMESH

PROFESSOR AND HEAD

DEPARTMENT OF PERIODONTICS

SIGNATURE

12. REMARKS OF CHAIRMAN AND PRINCIPAL

7Materials and method:

7.1 Source of the data:

Study will be conducted on 40 subjects reporting to The Oxford Dental College and

Hospital, Bangalore requiring replacement of one or few missing teeth.

7.2.1 Method of collection of data:.

20 subjects with thick gingival biotype requiring replacement of missing teeth

will be selected as GROUP I of which 10 subjects will be given platform matched

abutment and 10 subjects will be restored by implants with platform switched

abutment.

20 subjects with thin gingival biotype requiring replacement of missing will be

selected as GROUPII of which 10 subjects will be given standard sized abutment

and 10 subjects will be restored by implants with platform switching

Subjects will be explained elaborately the outcome of the proposed study

A verbal and written consent will be taken.

7.2.2 Inclusion criteria

1. Subjects aged between 20-55 years having normal periodontal

health and with one or few missing teeth.

2. The edentulous ridge should have a bone size of 5mm bucco-

lingually and 7mm mesio-distally.

3. Systemically healthy subjects.

4. Presence of good oral hygiene maintenance.

5. Subjects with good periodontal health

7.2.3 Exclusion criteria:

1. Patients on any medication

2. Pregnant and lactating women

3. Smokers

4. Subjects with defects in the edentulous ridge

7.2.4 Study duration: 18 months.

7.2.5 Statistical Analysis of Data: Analysis of variance(ANOVA).

Clinical Parameters To Be Assessed:

BASELINE

The gingival biotype will be evaluated by probe method using a plastic

periodontal probe.

SIGNATURE

Patient consent form

[Title of the study]

Name of the participant: ____________________________________________

Name of the Principal (Co-) Investigator: ______________________________

Name of the Institution: ____________________________________________

Name and address of the sponsoring (funding) agency(ies): ________________

________________________________________________________________________

Documentation of the informed consent

I, … … … … … … … … … ., have read the information in this form (or it has been read to me). I was free

to ask any questions and they have been answered. I am over 18 years of age and, exercising my free power

of choice, hereby give my consent to be included as a participant in “… … … … … .… … … … … … …

… … … … … … … . … … … … … … … … … … … … … ” (title of the study)

1. I have read and understood this consent form and the information provided to me.

2. I have had the consent document explained to me.

3. I have been explained about the nature of the study.

4. My rights and responsibilities have been explained to me by the investigator.

5. I have been advised about the risks associated with my participation in the study.

6. I have informed the investigator of all the treatments I am taking or have taken in the past… … .months

including any desi(alternative) treatments.

7. I agree to cooperate with the investigator and I will inform him/her immediately if I sufferunusual

symptoms.

8. I have not participated in any research study within the past … ..month(s).

9. I have not donated blood within the past … … months — Add if the study involves

extensiveblood sampling]

10. I am aware of the fact that I can opt out of the study at any time without having to give any reason and

this will not affect my future treatment in the hospital.

11. I am also aware that the investigators may terminate my participation in the study at anytime, for any

reason, without my consent.

12. I hereby give permission to the investigators to release the information obtained from me as result of

participation in this study to the sponsors, regulatory authorities, Governmentagencies, and ethics

committee. I understand that they may inspect my original records.

13. My identity will be kept confidential if my data are publicly presented.

14. If, despite following the instructions, I am physically harmed because of any substance or any procedure

as stipulated in the study plan, [my treatment will be carried out free at theinvestigational site / the

sponsor will bear all the expenses], if they are not covered by myinsurance agency or by a Government

program or any third party.

15. I have had my questions answered to my satisfaction.

16. I have decided to be in the research study.

Participant’initials: __________________________