Wisdom Teeth Clinical Trial
Official title:
Diagnosis, Evaluation and Treatment of Patients in Need of Third Molar Removal
Under this study, patients who require removal of their third molars (wisdom teeth) will be
diagnosed, evaluated and treated. In addition, tooth, bone and gum tissue samples will be
collected for use in bone, wound healing, microbiology and genetic research.
Patients 16-50 years of age who require wisdom tooth removal may be eligible for this study.
Participants may have one or all of their wisdom teeth removed at one time. The surgery is
done under local anesthetic. In addition, conscious sedation may be administered, if the
patient wishes.
Besides wisdom tooth removal, patients are asked to donate a small sample of jaw bone (from
the lining of the inner wall of the tooth socket) and gum tissue (from the area of the
surgical site). The samples are collected at the same time as the tooth extraction. The bone
sample is about the size of a pencil point (1.5 millimeters wide and 3 millimeters long) and
the gum tissue sample is 1 millimeter. Removal of these samples should not cause any
additional discomfort or increase the time required for the surgery or for healing.
OBJECTIVE:
The objective of this protocol is to obtain oral tissue for analysis by various research
groups at the National Institutes of Health (NIH).
STUDY POPULATION:
The protocol will enroll a convenience sample of 1,000 subjects between the ages of 18 to 50
years who are in need of third molar (wisdom tooth) extraction.
STUDY DESIGN:
Subjects will report to the National Institutes of Dental and Craniofacial Research (NIDCR)
for up to three visits. The first study visit will involve a screening evaluation to
determine protocol eligibility. Eligible subjects will be invited back for a second visit for
wisdom tooth extraction and collection of oral tissue for research purposes. All subjects
will remain on the protocol for three weeks after surgery, and they will have the option to
schedule a follow-up visit to the NIH for post-operative evaluation.
OUTCOME MEASURES:
This study does not involve any outcome measurements.
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