Status:
COMPLETED
Diagnosis, Evaluation and Treatment of Patients in Need of Third Molar Removal
Lead Sponsor:
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Wisdom Teeth
Eligibility:
All Genders
18-50 years
Brief Summary
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 ...
Detailed Description
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 c...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
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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
- Pregnant or nursing
- Clinical signs of infection and/or inflammation, or acute pain at any extraction site at the time of the screening evaluation
- Known bleeding disorders or conditions associated with bleeding, including Hemophilia, von Willebrand disease, protein C/S deficiency, antithrombin III deficiency, and liver disease.
- Currently using anticoagulation (blood thinning) medications, including but not limited to warfarin (Coumadin), ticlopidine (Ticlid) and clopidogril (Plavix). Subjects who are currently taking Aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) may be eligible for enrollment.
- Known or suspected allergy or adverse reaction to any of the agents used for local anesthesia, suture material, or conscious sedation medications
- Surgical removal of the wisdom teeth is expected to be unusually difficult based on panoramic radiograph. Indicators of unusual difficulty include increased depth of tooth impaction, extreme angulation of a tooth, and close proximity of a tooth to the inferior alveolar nerve canal and/or maxillary sinus.
Exclusion
Key Trial Info
Start Date :
April 14 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 28 2013
Estimated Enrollment :
718 Patients enrolled
Trial Details
Trial ID
NCT00316485
Start Date
April 14 2006
End Date
January 28 2013
Last Update
October 6 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892