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To,

The Chairman
Institutional Review Board
BSMMU, Dhaka.
Through Chairman, Department of Prosthodontics, BSMMU, Dhaka.
Subject: Application for ethical clearance of the thesis protocol titled,
CLINICAL EVALUATION BETWEEN MICRO CERAMIC COMPOSITE CROWN AND
METAL CERAMIC CROWN IN SINGLE DAMAGED TOOTH.

Sir,
With due respect, I would like to state that I am a student of MS (Prosthodontics), Phase B
( Residency) , Faculty of Dentistry, BSMMU, Dhaka. As a part of the course, I would like to
perform my thesis on title CLINICAL EVALUATION BETWEEN MICRO CERAMIC COMPOSITE
CROWN AND METAL CERAMIC CROWN IN SINGLE DAMAGED TOOTH under supervision of
Dr. Md. Mahbubur Rahman.
I shall be grateful if you kindly give me ethical clearance to go ahead with my study.
With regards
Yours sincerely,

Dr. Saiful Islam.
MS Phase-B Resident
Department of Prosthodontics,
Faculty of Dentistry, BSMMU, Dhaka.
Tick () the appropriate answer to each of the following
(If not Applicable write NA)

1. Source of Population: 4. Are subjects clearly informed
about:

a. Patient? Yes No a. Nature and purpose of the
study?
Yes No
a. Healthy subjects? Yes No b. Procedures to be followed
including alternatives
used?
Yes No
c. Minors or Person?
Under guardianship
Yes No c. Physical risks? Yes No
2. Does the study involve: d. Private questions? Yes No
a. Physical risks to the
subjects?
Yes No e. Mental risks? Yes No
b. Social risks? Yes No f. Benefits to be derived? Yes No
c. Psychological risks to
subjects?
Yes No g. Right to refuse to
participate or to withdraw
from the study?
Yes No
d. Discomfort to subjects? Yes No h. Confidential handling of
data?
Yes No
e. Invasion of the body? Yes No i. Compensation where there
are risks or loss of working
time, privacy involved in
any particular procedure?
NA
f. Invasion of privacy? Yes No 5. Will signed consent/verbal
consent be required:

g. Disclosure of
information damaging to
subjects or others?
Yes No a. From subjects? Yes No
3. Does the study involve: b. From parents or guardian
(if subjects are minor)
Yes No
a. Use of records (hospital,
medical, death, birth, or
other)?
Yes No 6. Will precautions be taken to
protect anonymity of the
subjects?
Yes No
b. Use of fetal tissue or
abortus?
Yes No
c. Use of organs or body
fluids?
Yes No
To
The Chairman
Institutional Review Board
BSMMU, Dhaka.

Through Chairman, Department of Prosthodontics, BSMMU, Dhaka.

Subject: Application for ethical clearance of the thesis protocol titled ,
CLI NI CAL EVALUATI ON BETWEEN MI CRO CERAMI C COMPOSI TE CROWN AND
METAL CERAMIC CROWN IN SINGLE DAMAGED TOOTH.

Sir,
With due respect and humble submission, I would like to state that I am a student of
MS Residency (Prosthodontics) Phase - B at BSMMU, Dhaka. As part of the course,
I would like to perform my thesis on title CLINICAL EVALUATION BETWEEN
MICRO CERAMIC COMPOSITE CROWN AND METAL CERAMIC CROWN
IN SINGLE DAMAGED TOOTH under supervision of Asso. Prof. Dr. Md.
Mahbubur Rahman.
I shall be grateful if you would kindly give me the ethical clearance to go ahead with
my study.
With regards.
Yours sincerely,

Dr. Saiful Islam
MS Phase-B Resident
Department of Prosthodontics
Faculty of Dentistry
BSMMU, Dhaka.

To
Chairman
Department of Prosthodontics.
Faculty of Dentistry
Bangabandhu Sheikh Mujib Medical University (BSMMU)
Shahbag, Dhaka.



Subject: Prayer for the approval of the thesis protocol of MS Thesis



Dear Sir,

With due respect, I would like to state that I appeared MS Phase-A (Prosthodontics) examination
in January 2012 and passed in time.


As a requirement of this ongoing course, thesis work has to be undertaken. After reviewing
available literatures and consultation with the honorable teachers, I have decided to do my thesis
work on the following title.


Title: CLINICAL EVALUATION BETWEEN MICRO CERAMIC COMPOSITE CROWN
AND METAL CERAMIC CROWN IN SINGLE DAMAGED TOOTH.


I therefore, hope that you would be kind enough to approve my thesis protocol enclosed
herewith and supervise me in my thesis work.




Yours obediently

Dr. Saiful Islam
MS Phase-B Resident
Department of Prosthodontics
Faculty of Dentistry
BSMMU, Dhaka.


PROTOCOL FOR THESIS

TITLE: CLI NI CAL EVALUATI ON BETWEEN MI CRO CERAMI C
COMPOSI TE CROWN AND METAL CERAMI C CROWN I N SI NGLE
DAMAGED TOOTH.



Name of the Supervisor


________________________
(Signature)
Dr. Md. Mahbubur Rahman
BDS, DDS, PhD
Associate Professor & Chairman
Department of Prosthodontics
Faculty of Dentistry, BSMMU, Dhaka.




Name of the Researcher


____________________
(Signature)

Dr. Saiful Islam

MS Resident , Phase - B
Department of Prosthodontics
Faculty of Dentistry, BSMMU, Dhaka.
BOARD OF APPROVAL


CHAIRMAN

Dr. Md. Mahbubur Rahman
BDS, DDS, PhD
Associate Professor & Chairman
DEPARTMENT OF PROSTHODONTICS
FACULTY OF DENTISTRY,BSMMU, DHAKA

. .
(Signature)
MEMBERS

1. DR.MASUDUR RAHMAN
BDS.MS.FCPS
ASSISTANT PROFESSOR
DEPARTMENT OF PROSTHODONTICS
FACULTY OF DENTISTRY, BSMMU ,DHAKA
..
(Signature)

2. DR. AMZAD HOSSAIN
BDS, MS, FCPS, MSc.
ASSISTANT PROFESSOR
DEPARTMENT OF PROSTHODONTICS
FACULTY OF DENTISTRY, BSMMU. DHAKA
...
(Signature)

ABSTRACT FOR INSTITUTIONAL REVIEW BOARD (IRB)

TITLE: CLINICAL EVALUATION BETWEEN MICRO CERAMI C COMPOSI TE
CROWN AND METAL CERAMIC CROWN IN SINGLE DAMAGED TOOTH.

Esthetic is one of the most important concern for patients appearance during the
preparation of the artificial crown. Esthetic dentistry progressively introduces different
prosthesis material and crown preparation technique. Material selection play the vital role
for best esthetic outcome. Esthetic dentistry continues to develop through innovation of
different materials for crown preparation over the last decade. The patients expectation of
getting more natural appearance has significantly increased for best outlook. The
conventional material for preparation of esthetic crown is porcelain fused to metal, but it
has some drawbacks and may cause failure of the restoration due to crack or chips out of
porcelain from the metal. To overcome the problem, advances in dental technology have
introduced some new material to provide better restoration, according to manufacturer,
this material is more esthetic by transmission of natural light like enamel and dentin, has
sufficient strength to resist fracture, less wear on occluding with opposite dentition, high
elasticity and good color stability. Many laboratory experiment have been done to
establish the best esthetic material for crown, among the material micro ceramic
composite, commercially called Ceremage has all the desired properties, but till now
only a few clinical studies are available regarding this material.


OBJECTIVES
The general objective of this study is to compare and evaluate the clinical performance
between micro ceramic composite crown and metal ceramic crown.
MATERIALS AND METHOD
Forty patients will be selected for the study which will treat in the Department of
Prosthodontics, Faculty of Dentistry, Bangabandhu Sheikh Mujib Medical University
(BSMMU). Thorough history taking and clinical examination those teeth failed to meet
inclusion criteria will be rejected. Thus, 40 teeth that fulfilled the inclusion criteria will
be selected for the study after clinical evaluation. The total 40 samples will be divided
into two groups Group 1: Preparation of 20 micro ceramic composite crown. Group 2:
Preparation of 20 metal ceramic crown. A written informed consent will be obtained for
every patient from the patients or patients guardian. The prosthesis will be examined by
two examiners and will be record in the data collection sheet. Follow up will be given
after 06 and 12 months. Findings will be collected in a prepared data sheet and will be
kept confidential. Clinical evaluation will be done on the basis of the modified USPHS
(United States Public Health Service) criteria. Statistical analysis will be done by SPSS
14.0 version. The result will be reported as mean + SD (standard deviation) and
comparison will be done by T-test, and p value of <0.05 will be considered significant.








Clarification of the ethical issue:

1. The study will select adult patents (18 years onward) who can give valid consent.

2. The study does not pose any potental risks which will be discussed with the patents
partcipatng in the study.

3. All measures will be taken to protect anonymity of the partcipatng subject. To do so
name and address of the subjects will be recorded on a separate sheet and specifc code
will be assigned to them by the Guide. The same code will be put to the
interview/examinaton schedule that will be given to the principal investgator for
conductng the interview.

4. The interview of the subjects, clinical examinaton will be performed at the respectve
department afer explaining the nature and purpose of the study to them. No
compensaton will be given to the study subjects, as the data will be collected at the
hospital premises, where they have atented for their own interest.

5. The study will beneft the individual subjects as the informaton derived from them
will help Dental surgeons to select beter material for artfcial crown for management of
single damaged tooth in future.

6. The study does not involve the testng new drugs, use of organs and tssues.





LIST OF DOCUMENTS FOR ETHICAL REVIEW COMMITTEE

1. Application for IRB Clearance
2. Check list
3. Abstract for Ethical review committee
4. Project Proposal
5. Proposal summary
6. Thesis Protocol
7. Procedure for confidentiality
8. Patients data collection sheet
9. Informed consent form (In Bangla).










INDEX

1. Part A: Project Proposal 1
2. Part B: Proposal Summary 2
3. Part C: Protocol
Introduction 5
Rationale of study 11
Hypothesis 12
Objectives 12
Methodology 13
Study Procedure 18
Data processing and analysis 20
Ethical consideration 21
Confidentiality 21
Budget 22
References 23
Informed consent form 25
Appendices 25
Data collection sheet 27
Record of treatment 28
Evaluation sheet 29
Working definitions 30