Collecting teeth and tissue from patients needing wisdom tooth removal
Oral Specimen and Data Acquisition Study of Subjects Requiring Third Molar Removal
This study is collecting teeth and tissue from people aged 16 to 50 who need their wisdom teeth removed to help improve our understanding of oral health and dental surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 16 Years to 50 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT01805869 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect data and surgical waste tissue from individuals aged 16 to 50 who require third molar extraction at the NIH NIDCR Dental clinic. Participants will undergo a screening visit, a surgery visit for tooth extraction, and a follow-up visit for post-operative evaluation. The collected specimens will be used for research to enhance understanding of oral health and improve dental surgical skills. The study seeks to enroll a convenience sample of up to 10,000 subjects to gather generalizable knowledge about tooth diseases.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16 to 50 who need clinically indicated extraction of their wisdom teeth.
Not a fit: Patients who are pregnant, nursing, or have medical conditions that prevent safe extraction will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved oral health practices and enhanced surgical techniques for dentists.
How similar studies have performed: While this approach of collecting surgical waste for research is not novel, it has shown potential in enhancing dental education and research outcomes in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Janice S Lee, DDS, MD — National Institute of Dental and Craniofacial Research (NIDCR)
- Study coordinator: Sharon Mitchell
- Email: sharon.mitchell@nih.gov
- Phone: (301) 496-4372
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.