INSTITUTIONAL REVIEW BOARD

SRM DENTAL COLLEGE,

RAMAPURAM, CHENNAI-89

INFORMATION SHEET

Comparison of the rate of orthodontic space closure with and without

probiotic supplements: a randomized control trial
I, Dr. Parameswaran T M a postgraduate student at the SRM dental college is conducting a
study to compare the rate of orthodontic space closure with and without probiotic
supplements.

You are being invited to take part in the research. Before you decide it is important to
understand why the research is being done and what it involves. Please take time to read the
following information carefully. Ask us if there is anything that is not clear of if you would
like more information. Take time and decide whether or not you wish to take part.

The standard procedure is to close the orthodontic space without any supplemental therapy.
For this research you may or may not be prescribed a probiotic capsule daily as a supplement
which has to be used for 90 days following which the rate of space closure will be measured.
Duration of this study is 90 days.The prescribed probiotic capsule has been used as a
nourishing supplement and for treatment of various conditions including bone degeneration
for which it has no side effects and completely Safe as it contains beneficial good bacteria for
the human gut/intestine.

You do not have to decide today whether or not you will participate in the research. Before
you decide, you can talk to anyone you feel comfortable with about the research. Your
decision not to participate in this research study will not affect your dental care or your
relationship with the investigator or the institution.

The participation in this research is purely voluntary and you have the right to withdraw from
this study at any time during the course of the study without giving any reasons.You may be
taken off the study without your consent if you do not follow instructions of the investigators
or the investigator thinks that further participation might cause you harm.

There will be small meetings in the orthodontist community and the results will be discussed.
After these meetings, we will publish the results in order that other interested people may
learn from our research. Confidential information will not be shared. This proposal has been
reviewed and approved by The Institutional Review Board, which is a committee whose task
it is to make sure that research participants are protected from harm.
 INSTITUTIONAL REVIEW BOARD
SRM DENTAL COLLEGE,
RAMAPURAM, CHENNAI-89

CERTIFICATE OF CONSENT
I have read the foregoing information, or it has been read to me. I have had the opportunity to
ask questions about it and any questions that I have asked have been answered to my
satisfaction. I consent voluntarily to participate as a test or control participant in this study
where I may or may not be prescribed a probiotic capsule as a supplement for 90 days.

Name of Participant__________________

Signature of Participant ___________________

Date ___________________________ Day/month/year
  Statement by the researcher/person taking consent
I have accurately read out the information sheet to the potential participant, and to the best of
my ability made sure that the participant understands that the following will be done.
I confirm that the participant was given an opportunity to ask questions about the study, and
all the questions asked by the participant have been answered correctly and to the best of my
ability. I confirm that the individual has not been coerced into giving consent, and the consent
has been given freely and voluntarily.
A copy of this ICF has been provided to the participant.
Name of Researcher/person taking the consent________________________
Signature of Researcher /person taking the consent______________________
Date ___________________________ Day/month/year

If illiterate
A literate witness must sign (if possible, this person should be selected by the participant and
should have no connection to the research team). Participants who are illiterate should
include their thumb-print as well.

I have witnessed the accurate reading of the consent form to the potential participant, and the
individual has had the opportunity to ask questions. I confirm that the individual has given
consent freely.
Print name of witness_____________________
Thumb print of participant
Signature of witness ______________________
Date ____________ Day/month/year
INSTITUTIONAL REVIEW BOARD
SRM DENTAL COLLEGE,
RAMAPURAM, CHENNAI-89