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RecruitingNCT01805869Updated Oct 26, 2026

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

An observational study in Stomatognatic, Tooth Diseases and Diseases, sponsored by National Institute of Dental and Craniofacial Research (NIDCR). Recruiting at 1 site in United States. Open to participants aged 16 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by National Institute of Dental and Craniofacial Research (NIDCR) · Observational

From the registry’s dates

  • Started Jun 2013; still recruiting 13 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
16 Years to 50 Years
Sex
All
01

Study 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.
Read the detailed description

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.

02

Conditions studied

  • Stomatognatic
  • Tooth Diseases
  • Diseases
  • Tooth
  • Tooth Impaction

Keywords

  • Third Molar
  • Specimen Acquisition
  • Natural History
03

In context

Tooth Diseases

79 studies on the registry are indexed under Tooth Diseases; 11 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 224 across 16 observational studies indexed under Tooth Diseases.

Browse Tooth Diseases studies →

Lead sponsor

National Institute of Dental and Craniofacial Research (NIDCR) is the lead sponsor of 94 studies on the registry; 9 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 5 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (ASA) status I or II
  • Able to understand and sign an

Exclusion criteria

EXCLUSION CRITERIA:

  • Pregnant or nursing women
  • Unable to have third molar extraction as determined by NIDCR surgeon/dentist, due to medical conditions (beyond ), 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)

Groups and cohorts

  • Healthy volunteers

    Male or female ages 16-50

06

What researchers measure

Primary outcomes

  1. data collection

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

    Time frame: 16 years

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — It is not yet known if there will be a plan to make IPD available

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT01805869
Responsible party
Sponsor
First posted
Mar 6, 2013
Start date
Jun 19, 2013
Primary completion
Dec 31, 2029 (estimated)
Last update
Oct 26, 2026

Study contacts

Sharon M Mitchell
Contact
sharon.mitchell@nih.gov
(301) 496-4372
Janice S Lee, DDS, MD
principal investigator · National Institute of Dental and Craniofacial Research (NIDCR)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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