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

NCT01805869 | Recruiting

• 2 other identifiers: 13003313-D-0033
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- The third molars (wisdom teeth) normally grow in during late adolescence or early adulthood. Many people need or choose to have these teeth removed with oral surgery. Normally, the removed teeth and tissue are thrown away as medical waste. However, oral health researchers want to collect the teeth and tissue for research. They also want to encourage dentists at the National Institutes of Health to improve their skills in oral surgery. This study will collect the teeth and tissue of people who need to have oral surgery to remove their wisdom teeth. Objectives:

• To provide continued dental skills training for dentists at the National Institutes of Health.
• To collect teeth and tissue samples following wisdom tooth removal surgery. Eligibility: \- Individuals between 16 and 50 who need to have their wisdom teeth removed. Design:
• This study will involve a minimum of three visits. There will be a screening visit, a surgery visit, and at least one follow-up visit.
• Participants will be screened with a physical exam and medical history. A full dental exam with x-rays will be given to evaluate the need for surgery.
• At the second visit, participants will have oral surgery to remove their wisdom teeth. The teeth and tissue removed during the surgery will be collected for study.
• Participants will receive drugs to control the pain after surgery. They will also be able to contact a dentist if there are any problems.
• Between 7 and 21 days after surgery, participants will have a followup visit to check the healing. If they are having no problems, this will be the last visit. If there are any postsurgery issues, they will be scheduled for additional visits as needed.

Conditions

Tooth Diseases; Tooth; Tooth Impaction; Stomatognatic; Diseases

Keywords

Third Molar; Specimen Acquisition; Natural History

Outcome Measures

Primary Outcomes (1)

• data collection

  If trends emerge that warrant further exploration, outcome measures will be described

  16 years

Study Arms (1)

Healthy volunteers

Male or female ages 16-50

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The protocol will enroll a convenience sample of 10,000 subjects ages \>16-50 in need of clinically indicated extraction of third molars.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Dental and Craniofacial Research (NIDCR): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Tooth Diseases; Disease; Tooth, Impacted

Condition Hierarchy (Ancestors)

Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Janice S Lee, DDS, MD

  National Institute of Dental and Craniofacial Research (NIDCR)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Mitchell

CONTACT

(301) 496-4372; sharon.mitchell@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2013
• First Posted: March 6, 2013
• Study Start: June 19, 2013
• Primary Completion (Estimated): December 31, 2029
• Last Updated: April 30, 2026

Record last verified: 2026-04-28

Locations

US (1)