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Consent and Information Form

Effect of micro-osteoperforations on rate of tooth movement


Introduction. I, ____________________________, have been asked to participate in
this study. Chi H. Bui DMD, MS, who is conducting this research in association with the
Department of Orthodontics of West Virginia University School of Dentistry, has
explained the study to me.
Purpose of the study. The purpose of this study is to learn more about the effects of
Propel therapy on orthodontic tooth movement, namely in extraction sites.
Description of procedures. This study will be performed at Dr. Buis private practice.
My braces will be bonded to my teeth, in the normal way, using an orthodontic adhesive
or glue. Propel therapy will be used on one side of the mouth, while the other side will
have the same adjustments without the use of the Propel pen. I have been given an
opportunity to examine the instruments and procedures which I will be subjected to and I
understand that I do not have to participate in any of the procedures. This study will
consist of 20 comprehensive orthodontic patients with the extraction of upper premolars,
and they will be randomly divided into 2 groups by flipping a coin. The first group will
have the Propel therapy on the right side around the extraction site, while the second
group will have it used on the left side. This study will compare the rate of space closure
on the side with Propel therapy by measuring the mesial-distal space between the teeth at
each visit.
Risks and discomforts. The tissue where the Propel pen is used may have temporary
sensitivity usually lasting from 30 minutes to 2 hours. The tissue may also be irritated
from the use of the topical anesthetic. The only other risks involved are the routine risks
and discomforts associated with orthodontic treatment, which have been explained to me.
Participation in this study will not affect my orthodontic treatment plan.
Benefits. I understand that this study may not be of direct benefit to me, but the
knowledge gained may be of benefit to other dental patients. If the Propel device can
accelerate orthodontic tooth movement, then I will benefit from a shorter treatment time.
__________________
Initials
date
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Effect of micro-osteoperforations on rate of tooth movement

Alternatives. I understand that I do not have to participate in this study. My orthodontic


treatment plan will not be affected by nonparticipation in the study.
Contact persons. For more information about this research, I can contact Dr. Bui at 714962-8880 or Dr. Peter Ngan at 304-293-5217. Dr. Bui can be contacted in case of an
orthodontic emergency. For more information regarding my rights as a research subject, I
may contact the executive secretary of the Institutional Review Board at 293-7073.
Financial Considerations. There are no special fees for participating in this study.
Voluntary Compensation. If I am injured as a result of this research, treatment will be
available. Compensation for my injuries will not be provided voluntarily by the
investigator, West Virginia University, or other associated affiliates.
Confidentiality. I understand that any information obtained as a result of my
participation in this research study will be kept as confidential as legally possible. I
understand that these research records, just like hospital records, may be subpoenaed by
court order or may be inspected by federal regulatory authorities. In any publications that
result from this research, my name or any information from which I might be identified
will not be published without my consent.
Voluntary Participation. Participation in this study is voluntary. I understand that I
may withdraw from this study at any time. Refusal to participate or withdrawal will
involve no penalty or loss of orthodontic or dental care for myself. I have been given the
opportunity to ask questions about the research, and I have received answers concerning
areas I did not understand. Upon signing this form, I will receive a copy.
I willingly consent to my participation in this study.
________________________________
Signature of subject

_________________
Date

________________________________
Signature of investigator

__________________
Date

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