Appendix 1
APPLICATION TO THE BVDUDC&H-PUNE/INSTITUTIONAL ETHICS
COMMITTEE
FOR APPROVAL OF A RESEARCH PROJECT
1.
Basic data
Name/s of Applicant Dr.Shilpa Choudhari
Address for correspondence:
(With email ID & phone number)
Permanent address for future
Dept. of Periodontology; BVDUDC&H, Pune.
Shilpa_nalge@yahoo.com
020-24373266 ext. no. 214
Dept. of Periodontology; BVDUDC&H, Pune. correspondence
Project Title
Comparative evaluation of ozone therapy as an adjunct to Scaling and Root Planing with
Scaling and Root Planing alone in cases of
Chronic Periodontitis- A Clinical and
Microbiological Study.
Principal investigator
Address of PI
Co- investigator
Address of Co- investigator
Sponsoring Organization
Dr.Shilpa Choudhari
E3/203 Madhuban soci. Alandi road,
Vishrantwadi, Pune.
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Site contact details (address/ phone no of place where research work will take place)
Dept. Of Periodontology, BVDUDC&H, Pune.
020-24373266 ext. no. 214
Date of application submission 31 st October 2012
2.
Back ground information:
Chronic Periodontitis is a multifactorial inflammatory disease that is associated with loss of supporting tooth structures.

Standard treatment of Periodontitis is scaling and root planing, but it is difficult to eliminate complete subgingival bacteria and calculus due to complex anatomy of teeth and mechanical limitation to the size of instrument to reach in deep pocket.
Ozone therapy can prove to be effective as it has property of oxidizing biomolecules, it disrupts microbial cell wall in seconds, leading to cell lysis. Also it has got many other properties like anti-inflammatory, immunostimulating (influence on cellular and humoral immunity), biosynthetic (activates mechanism of protein synthesis), haemostatic and analgesic. It is safe in aqueous form; also it does not develop any resistance.
Thus adjunctive use of Ozone therapy can be helpful in the non surgical treatment of Chronic Periodontitis minimizing the surgical intervention.
This study was therefore planned to see the effect of aqueous ozone
(4mg/L) as an adjunct to scaling and root planing in cases of Chronic
Periodontitis.
3.
Aim and Objectives
3.1
Aim:
To assess the effectiveness of ozone therapy in the nonsurgical treatment of Chronic Periodontitis.
3.2 Objectives:
1. To compare the effect of aqueous ozone (4 mg/L) irrigation as an
adjunct to scaling and root planing along with scaling and root planing
alone on bleeding index in cases of Chronic Periodontitis.
2. To compare the effect of aqueous ozone (4 mg/L) irrigation as an
adjunct to scaling and root planing along with scaling and root planing
alone on pocket depth in cases of Chronic Periodontitis
.
3. To compare the effect of aqueous ozone (4 mg/L) irrigation as an
and root planing along with scaling and root planing alone on total
microbial count in cases of Chronic Periodontitis.

4.
Study design
4.1
Selection and exclusion criteria of study participants:
Inclusion criteria:
 Chronic Periodontitis subjects.
 Pocket depth of 6 -7mm.
 Subjects with age ranging from 30 years and
above.
Exclusion criteria:
 H/O Periodontal treatment within last 06 months.
 Pregnant patients.
 H/O Glucose-6-phosphate-dehydrogenase
deficiency.
 H/O systemic problems
Hyperthyroidism,severe such as anaemia,severe myasthenia, Active haemorrhage, Acute alcohol intoxication, Recent myocardial infarction.
 Subjects using any chemical plaque inhibitors.
 Subjects using Antioxidants .
 Smokers.
 H/O antibiotics or antimicrobial therapy or
antibiotics within last 6 months.
4.2
Study group: Chronic Periodontitis subjects with pocket depth of
6-7mm.
4.3
Sample size with justification: 20 subject of Chronic Periodontitis.
4.4 Treatment details: Periodontitis subjects will be included in the study.
A detailed case history will be obtained from each subject using special
proforma and subjects diagnosed with Chronic Periodontitis will be
included. An informed written consent will be obtained from each
subject. 20 subjects of Chronic Periodontitis fulfilling the criteria will
be selected.
In every patient one quadrant will undergo scaling and root

planing alone and other quadrant will undergo scaling and root planing
along with irrigation of one site of this quadrant with aqueous ozone
(4mg/L).
Microbial analysis will be carried out for 05 subjects from each group.
Plaque samples will be taken from pocket with the help of curette before
scaling and root planning from both the sites.
Second plaque sample will be taken on the next day after completion of
treatment from both the sites.
Bleeding index and Pocket depth will be noted down after 03 weeks of
treatment.
4.5 Outcome measures: Ozone therapy can thus prove to be effective
in the treatment of chronic Periodontitis and can
avoid surgical intervention
5. Assessment of efficacy
5.1 Method of data collection: Plaque sample will be collected from the pocket with the help of currete before and after completion of scaling and root planing. Plaque sample will be sent to laboratory as early as possible. Nutrient Agar plate will be used to culture bacteria.
5.2 Method of data analysis:
1.
Case history
2.
Clinical analysis
3.
Microbial analysis.
4.
Indices
6. Assessment of safety of trial subjects/research participants
6.1 Invasive procedure. In every patient one quadrant will undergo

scaling and root planing alone and other quadrant will undergo scaling
and root planing along with irrigation of one site of this quadrant with
aqueou ozone.
6.2 For every individual patient, sterilized instrument set will be used. New set
of sterilized pair of gloves & mask will be used by investigator for every
individual patient. Ozone in concentration of 4mg/L in aqueous form is
very safe.
6.3 It may cause mild irritation but will not produce any harmful effect.
6.4 Patient will be observed for one hour and then asked to leave the clinic.
Followup will be done next day and after three weeks. Patient will be asked
to report immediately if he feels any discomfort.
7.
Risk and Benefits
7.1
It may cause mild irritation.
7.2
Rinse with the water.
7.3
Adjunctive use of Ozone therapy can be helpful in the non surgical treatment of Chronic Periodontitis by minimizing the surgical intervention.
8 Safety and other controls
Yes, this study involves interventional procedure like scaling and root
planing and use of aqueous ozone for irrigation.
Justification- scaling and root planing is a very routine nonsurgical
procedure performed in periodontology. Ozone is very safe when it is used
in aqueous form and we are using it in very mild concentration.
9 Consent:
A copy of consent form & information sheet is attached to the Appendix 1.
9.1 A consent form in English & Vernacular Language will be provided to the subjects. The consent form has a written explanation of the study and the benefits of the results obtained from the study.

9.2 The consent form informs the subjects that they are under no compulsion to participate and may withdraw at any time without jeopardizing any service delivery or their relationship with the researcher.
9.3 No data will be collected on those who refuse consent.
10. Confidentiality
Method of maintaining confidentiality of participants: All the personal information & reports of the patients included in the present study will be kept strictly confidential.
11. Signatures of responsible investigators
Principal Investigator:
Dr. Shilpa Choudhari
Post –graduate student
Dept. of Periodontology,
BVDU Dental College and Hospital, Pune.
Post –graduate Guide:
Dr. Vishakha Patil
Professor
Department of Periodontology
BVDU Dental College and Hospital, Pune.

Head of department:
Dr. (Mrs.) Amita Mali
Principal and HOD
Department of Periodontology,
BVDU Dental College and Hospital, Pune.
Collaborator
Designation & Organization: ---------
Ethics Committee Chair Head of Institute

Appendix 2
Undertaking by the Investigator
01.
This research project (including collection of blood or tissues samples for research) will not be started until the final approval of the BVDUDC&H-
PUNE/IEC has been obtained.
02.
We agree to undertake research proposal involving human subjects in accordance with the ICH-GCP and ICMR ethical guidelines, 2006 till the draft guidelines for ASU drugs {rule 170, schedule Z} are confirmed. We will not modify the research protocol, consent, etc. without prior approval by the BVDUDC&H-PUNE/IEC.
03.
The investigators agree to obtain a properly informed and understood consent for all trial subjects before their inclusion in the trial in the informed consent form that is approved by the BVDUDC&H-PUNE/IEC.
Participants will receive an ‘information sheet’ which will detail the project design in simple understandable layperson’s language.
04.
The investigators agree to report within a week all serious adverse events
(SAE) associated with the trial in the SAE form to the BVDUDC&H-
PUNE/IEC. In the event of a death of the trial subject, the Secretary,
BVDUDC&H-PUNE/IEC and SRC, will be informed within 24 hours.
05.
The investigators agree to submit periodic 6 monthly progress report of the trial in the appropriate form. A final report will be submitted at the end of the trial.
06.
Full details on funding and a proposed budget are included with the trial proposal. The proposed budget is presented on the specific budget sheet
07. We understand that the BVDUDC&H-PUNE/IEC is concerned about transparent financial transactions during the trial. A report on how the trial funds were utilized will be presented to the EC along with the final project report at the end of the trial.
08.
For all research proposals that are sponsored by a pharmaceutical or biomedical company, we the investigators will ensure that the Sponsor
Company will underwrite all expenses such that neither the hospital nor

the study participants are made to spend while participating in the trial.
The investigators will also ensure that in the event of complications arising directly due to the trial or litigation, the cost of management or legal fees will be borne by the Sponsor Company totally.
09.
The investigators state that they do not stand to gain financially from the commercial sponsor and don’t have conflict of interest in the drug or product by way of consultations, shareholding, etc.
10.
The investigators will ensure that personnel performing this study are qualified, appropriately trained and will adhere to the provisions of the
BVDUDC&H-PUNE, approved protocol.
11.
All data collected during the research project, including those supported by commercial sponsors (e.g. pharmaceutical company), will remain the property of BVDUDC&H-PUNE/IEC.
12.
The salaries to staff employed for the research project will be as shown in the budget sheet and in accordance with the provisions made by the funding agencies.
13.
The case records (source documents) will be made available to members of the SRC or BVDUDC&H-PUNE/IEC any time for random verification and monitoring. The case records (source documents) will be preserved in the premises of BVDUDC&H-PUNE for at least 5 years after the last approval of application or publication.
14.
The investigators promise to ensure that there is no falsification of data when compared to the source documents. We agree to clarify any doubts or discrepancies that may arise during the data monitoring evaluation.
15.
All the findings and conclusions of the proposed project such as review of case records, analysis of forms of treatment, investigations, etc will be first presented to the staff members of BVDUDC&H-PUNE before they are released or presented elsewhere. The investigators will submit a copy of the abstract to the SRC and BVDUDC&H-PUNE/IEC well in advance of any proposed presentation at national or international conferences or seminars.

16.
The investigators will not issue any press release before the data and conclusions have been peer-reviewed by the BVDUDC&H-PUNE staff or published in a peer-reviewed journal.
17.
All serious injuries arising from the trial will be the responsibility of the investigators. The investigators agree to ensure that the sponsors undertake a product liability insurance to cover any expenses for injury or compensation arising from the study treatment.
18.
The investigators agree to transfer 15% of the total budget to
BVDUDC&H-PUNE as service charges. This will not apply to intramural projects, those co-sponsored by BVDU Dental College & Hospital Pune and collaborative projects with BVDUDC&H-PUNE.
19.
The investigators agree that the grant money will be spent in accordance with the budget proposal only. The funds will not be used for any other purposes without prior approval from the BVDUDC&H-PUNE/IEC. Thirty percent of the surplus grant if left over at the end of the study will be credited to BVDUDC&H-PUNE. The remaining 70% of the surplus grant money may be used by the investigators for conducting intramural research, improving teaching facilities in the department, providing financial assistance to investigators for conferences, etc after obtaining permission from the BVDUDC&H-PUNE/IEC. In case of government grants, the unspent balance will be spent/ returned as per the directives given along with the project sanction letter.
20.
The investigators will constantly inform the BVDUDC&H-PUNE/IEC about amendments in the study protocol, data collection forms, informed consent forms, budget expenses, salaries, other trial documents, etc. as and when they occur. No major changes in the treatment arms or the study protocol or randomization technique will be carried out without prior permission of the BVDUDC&H-PUNE/IEC.
21.
The investigators will comply with all policies and guidelines of the
BVDUDC&H Pune and affiliating/collaborating institutions where this

study will be conducted, as well as with all applicable laws regarding the research.
We the investigators of the proposed trial have read all the statements listed above and agree to observe / undertake these BVDUDC&H-
PUNE/IEC requirements while conducting our proposed project / trial.
Sign of PI:
Sign of Co-I: ----------
Date
Seal