StomatognaticNCT01805869
Oral Specimen and Data Acquisition Study of Subjects Requiring Third Molar Removal
An observational study of Stomatognatic and Tooth Diseases, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Stomatognatic, Tooth Diseases, Diseases
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2013to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
- Conditions
- Stomatognatic, Tooth Diseases, Diseases, Tooth, Tooth Impaction
- Keywords
- Third Molar, Specimen Acquisition, Natural History
- Medical subject headings
- Tooth Diseases, Disease, Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Male or female ages 16-50 |
What is being measured
The primary outcome is the main question the study is designed to answer.
data collection
If trends emerge that warrant further exploration, outcome measures will be described
Measured: 16 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study start19 Jun 2013
- Primary completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StomatognaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Janice S Lee, DDS, MD, Principal investigator, National Institute of Dental and Craniofacial Research (NIDCR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805869
- Sponsor's protocol ID
- 130033
- Other IDs
- 13-D-0033
- Status last verified
- 28 Sep 2026
- First submitted
- 5 Mar 2013
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Specimen and Data Acquisition Study of Subjects Requiring Third Molar Removal
- ClinicalTrials.gov ID
- NCT01805869
- Acronym / sponsor ID
- 130033
- Conditions
- Stomatognatic, Tooth Diseases, Diseases, Tooth, Tooth Impaction
- Keywords
- Third Molar, Specimen Acquisition, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- 19 Jun 2013 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- First posted
- 6 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | –Male or female ages 16-50 |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
data collection
Time frame: 16 years
If trends emerge that warrant further exploration, outcome measures will be described
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janice S Lee, DDS, MD principal investigator
National Institute of Dental and Craniofacial Research (NIDCR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stomatognatic and Tooth Diseases, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharon M Mitchell ((301) 496-4372, sharon.mitchell@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
data collection (time frame: 16 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.