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| ID | Type | Description | Link |
|---|---|---|---|
| 06-D-0144 |
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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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Males and females aged 18 to 50 years
Evidence of need for third molar extraction as determined by medical and dental history, as well as clinical and radiographic evaluation
Willing to provide at least one wisdom tooth for research purposes
Willing to provide one or more of the following tissue types for research purposes:
Excessive gingival tissue around extraction sockets
Oral tissues from the floor of the mouth, cheek, palate and/or lateral border of the tongue
Small biopsies of alveolar bone from the sockets that surround the wisdom teeth
America Society of Anesthesiologists (ASA) status I or II
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Carol W Bassim, D.M.D. | National Institute of Dental and Craniofacial Research (NIDCR) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12700154 | Background | Foster JS, Palmer RJ Jr, Kolenbrander PE. Human oral cavity as a model for the study of genome-genome interactions. Biol Bull. 2003 Apr;204(2):200-4. doi: 10.2307/1543559. | |
| 12754239 | Background | Palmer RJ Jr, Gordon SM, Cisar JO, Kolenbrander PE. Coaggregation-mediated interactions of streptococci and actinomyces detected in initial human dental plaque. J Bacteriol. 2003 Jun;185(11):3400-9. doi: 10.1128/JB.185.11.3400-3409.2003. |
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| 15639626 | Background | Kolenbrander PE, Egland PG, Diaz PI, Palmer RJ Jr. Genome-genome interactions: bacterial communities in initial dental plaque. Trends Microbiol. 2005 Jan;13(1):11-5. doi: 10.1016/j.tim.2004.11.005. |