Oral Specimen and Data Acquisition Study of Subjects Requiring Third Molar Removal

Objective

The objective of this protocol is to collect data and surgical waste tissue for research purpose in subjects undergoing clinically indicated wisdom teeth extraction at the NIH NIDCR Dental clinic with the aim of obtaining generalizable knowledge about oral health while utilizing surgical waste tissue for research studies.

Study Population

The protocol will enroll a convenience sample of 3,000 subjects ages greater than or equal to 16-50 in need of clinically indicated extraction of third molars.

Design

This is a data collection and specimen acquisition protocol. Data and oral tissue samples will be collected for research purpose in subjects undergoing extraction of third molar teeth at the NIH NIDCR dental clinic. If trends in data emerge that warrant further exploration, outcome measures will be identified, and IRB approval or determination of exemption will be requested to carry out the project. Oral specimens removed during a third molar extraction will be distributed for research with appropriate IRB approval.

Subjects will report to the NIH NIDCR dental clinic for 3 visits. The first visit will be a screening evaluation to determine protocol eligibility. Eligible subjects will return for a second visit for the third molar extraction procedure. The third visit will be scheduled approximately 3-40 days after surgery for a post-operative clinical evaluation. Additional visits for standard of care follow up or treatment may be required based on clinical status of subject after surgery.

Outcome Measures

Data collection includes demographics, medical/dental history, examination findings, pain management, medication regimen, adverse events and other data collected from all standard of care procedures.

Oral specimens removed during third molar extraction may include teeth, alveolar bone, excessive gingival tissue and other waste tissue and will be distributed for research as directed by IRB and OHSRP approval for sharing.

• INCLUSION CRITERIA:
• Ages greater than or equal to 16-50 years
• Clinical evidence of need for third molar extraction as determined by medical, dental, and radiographic evaluation by a NIDCR oral surgeon
• Willing to allow for the collection of extracted waste tissue (e.g., teeth, alveolar bone, excessive gingival tissue) to be used for research
• In good general health as defined by the American Society of Anesthesiologists (ASA) status I or II
• Able to understand and sign an informed consent

Exclusion criteria

• Pregnant or nursing women
• Unable to have third molar extraction as determined by NIDCR surgeon/dentist, due to medical conditions (beyond ASA I or II), complexity of the surgery, or history that precludes safe outpatient conscious sedation. These clinical decisions will be based on the risks and benefits related to the surgery.