RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA, BANGALORE
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR
DISSERTATION

1.

Name of the candidate and Dr. ROHAN.S,

address
POST GRADUATE STUDENT,
(In block address)
PLOT NO 9,18TH A CROSS 8TH MAIN
BANDAPPA
GARDEN
EXTENTION,
MUTHYALANAGAR
GOKUL
POST,
BANGALORE-560054
THE OXFORD DENTAL COLLEGE,
HOSPITAL&
RESEARCH
CENTRE,
BANGALORE.

2.

Name of the institution

3.

Course of study and subject

MASTER
OF
DENTAL
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

SURGERY,

Materials 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.

9.

SIGNATURE OF THE CANDIDATE

7.2.1 Method of collection of data:.

10.

20 subjects with thick gingival biotype requiring replacement of missing teeth

REMARKS
OFselected
THE as
GUIDE
will be
GROUP I of which 10 subjects will be given platform matched
abutment and 10 subjects will be restored by implants with platform switched

11.

abutment.
11.1 NAME AND DESIGNATION OF Dr. A.V. RAMESH
20 subjects with thin gingival biotype requiring replacement of missing will be
THE GUIDE
PROFESSOR AND HOD
selected as GROUPII of which 10 subjects will be given standard sized abutment
DEPARTMENT
PERIODONTICS
and 10 subjects will be restored by implants
with platform OF
switching

Subjects will be explained elaborately the outcome of the proposed study

A verbal and written consent will be taken.

SIGNATURE OF THE GUIDE

7.2.2 Inclusion criteria
11.2 CO-GUIDE

Dr. SANJAY MOHANCHANDRA

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

PROFESSOR AND HOD
health and with one or few missing teeth.
DEPARTMENT OF IMPLANTOLOGY
2. The edentulous ridge should have a bone size of 5mm buccolingually and 7mm mesio-distally.
3. Systemically healthy subjects.

SIGNATURE OF THE
CO-GUIDE
4. Presence of good oral hygiene maintenance.
5. Subjects with good periodontal health
Dr. A.V. RAMESH

11.2 HEAD OF THE DEPARTMENT

7.2.3 Exclusion criteria:

PROFESSOR AND HEAD

1. Patients on any medication

DEPARTMENT OF PERIODONTICS
2. Pregnant and lactating women
3. Smokers

SIGNATURE

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

12.

REMARKS OF CHAIRMAN AND

PRINCIPAL

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.
2.
3.
4.
5.
6.

I have read and understood this consent form and the information provided to me.
I have had the consent document explained to me.
I have been explained about the nature of the study.
My rights and responsibilities have been explained to me by the investigator.
I have been advised about the risks associated with my participation in the study.
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.

Participantinitials: __________________________