Appendix 1
APPLICATION
TO
THE
BVDUDC&H-PUNE/INSTITUTIONAL
ETHICS
COMMITTEE
FOR APPROVAL OF A RESEARCH PROJECT
1. Basic data
Name/s of Applicant
Address
(With
for
Dr.Pallavi Patil
correspondence: Dept. of Periodontology; BVDUDC&H, Pune.
email
ID
&
phone pallaveewardhamane@gmail.com
number)
020-24373266 ext. no. 214
Permanent address for future
correspondence
Dept. of Periodontology; BVDUDC&H, Pune.
Evaluation of the clinical and microbiological
efficacy of herbal mouthwash in comparison
with 0.2% Chlorhexidine Gluconate on
plaque and gingival inflammation.
Project Title
Principal investigator
Dr.Pallavi Patil
Address of PI
A-603 Kshitij Sahakarnagar-2,Pune.
Co- investigator
-------------------------------------------------------
Address of Co- investigator
--------------------------------------------------------
Sponsoring Organization
--------------------------------------------------------
Site contact details (address/
phone
no
of
place
where
research work will take place)
Date of application submission
Dept. Of Periodontology, BVDUDC&H, Pune.
020-24373266 ext. no. 214
31st October 2012
2. Back ground information:
Gingival and periodontal diseases are affecting the majority of population
across the world. Dental plaque has been recognized as a primary
etiologic factor. Plaque control can be achieved by mechanical &
chemical means. Mechanical methods are time consuming and their
effectiveness depends on skills and technique. Adequate plaque control
cannot be maintained in interproximal sites, so use of chemicals as an
adjunct to mechanical plaque control is needed. Several antiplaque
agents are available in the market eg. Bisbiguanides (Chlorhexidine),
Cetylpyridinium Chloride (CPC), essential oils, quaternary ammonium
compounds, but most of them have side effects after long-term usage.
Hence, a need was felt of an alternative medicine. Natural compounds
contained in an herbal cocktail can act in a synergistic manner within
the human body and can provide unique therapeutic properties with no
or minimum side effects.
This study is planned to investigate the microbiolocal and clinical
efficacy of the use of herbal mouthwash over a period of 3 weeks. The
clinical efficacy of the mouthwash will also be compared to Chlorhexidine
Gluconate.
3. Aim and Objectives
3.1 Aim:
To assess the clinical and microbiological efficacy of herbal mouthwash
in comparison with 0.2% Chlorhexidine Gluconate on plaque and
gingival inflammation.
3.2 Objectives:
1) To study the clinical efficacy after the use of herbal mouth wash.
2) To compare the efficacy of herbal mouthwash with 0.2% Chlorhexidine
Gluconate
3) To evaluate the changes in the total microbial load after scaling and
use of experimental Herbal and 0.2% Chlorhexidine Gluconate mouth
Wash.
4. Study design
4.1 Selection and exclusion criteria of study participants:
Inclusion criteria:

Subjects older than 18 years of age.

Subjects of either sex.
 Not undergone scaling since past 6 months.
 Not participated in similar investigations in past 4 weeks.
 Subjects systemically healthy and without any relevant medication.
 Subjects willing to give an informed consent and follow the schedule
 Subjects with moderate to severe gingivitis.
Exclusion criteria:
 Pregnant or lactating women.
 Known allergies to any mouth wash, pharmaceutical products or its
components or
Ingredients in the test products.
 Having used any mouthwash in past 4 weeks.
 Antibiotic therapy within last 30 days.
4.2 Study group: Subjects with moderate to severe gingivitis
4.3 Sample size with justification: 60 subjects of moderate to severe
Gingivitis.
4.4 Treatment details:
60 subjects with moderate to severe gingivitis will be included in this
study. Amongst these, 50 subjects will be randomly divided into 2
groups. For both groups case history along with Plaque index and
Gingival index will be recorded. An informed written consent will be
obtained from each subject. Scaling and root planing will be carried
out in the same appointment. Oral hygiene instructions will be given.
Then one group will be prescribed Herbal mouthwash and other will
be prescribed 0.2% Chlorhexidine mouthwash. Subjects will be asked
to rinse twice daily with 10 ml of respective mouthwash for one
minute. Subjects will be assessed again after 3 weeks for plaque index
and gingival index.
For remaining 10 subjects, Plaque samples will be collected at
baseline. Case history & plaque and gingival index will be recorded.
An informed written consent will be taken. Scaling and root planing
will be carried out in the same appointment. Oral hygiene instructions
will be given. Subjects will be given experimental herbal mouth wash
and told to use it for 3 weeks. Plaque samples will be collected &
plaque index and gingival index will be recorded after 3 weeks.
After a wash out period of 1 month, plaque samples will be collected.
Plaque index and gingival index will be recorded. Then the subjects
will be given 0.2% Chlorhexidine Gluconate mouth wash & instructed
to use it for 3 weeks. After 3 weeks, Plaque index and gingival index
will be recorded. Plaque samples will be collected and sent for
microbial count.
4.5 Outcome measures: Herbal mouthwash can prove to be effective in
treatment of moderate to severe gingivitis.
5. Assessment of efficacy
5.1 Method of data collection: Plaque sample will be collected from the pocket
with the help of curette 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. Indices
4. Microbial analysis
6. Assessment of safety of trial subjects/research participants
6.1 Invasive procedure. Every patient will undergo Scaling and root planing
herbal or 0.2% Chlorhexidine Gluconate mouthwash will be prescribed.
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. Herbal or 0.2% Chlorhexidine Gluconate mouthwash
will be prescribed. Both mouthwashes have been proved safe for medicinal
purpose.
6.3 It may cause mild irritation & staining but will not produce any harmful
effect.
6.4 Subjects will be given proper instructions for use of mouthwash
Follow up will be done next day and after three weeks. Patient will be asked
to report immediately if any untoward reaction is noticed.
7.Risk and Benefits
7.1
It may cause mild irritation and staining of teeth.
7.2
Inform operator and rinse with the water.
7.3
Use of herbal mouthwash can be helpful in the treatment of moderate to
severe gingivitis patients with no/minimum side effects.
8 Safety and other controls
Yes, this study involves interventional procedure like scaling and root
planing and use of herbal & 0.2% Chlorhexidine Gluconate mouthwash.
Justification- Scaling and root planing is a very routine nonsurgical
procedure performed in Periodontology. Herbal mouthwash is very safe
when it is used in aqueous form.
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. Pallavi Patil
Post –graduate student
Dept. of Periodontology,
BVDU Dental College and Hospital, Pune.
Post –graduate Guide:
Dr. Rohini Mali
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&HPUNE/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&HPUNE/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&HPUNE/IEC requirements while conducting our proposed project / trial.
Sign of PI:
Sign of Co-I: ---------Date
Seal