Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    13-D-0033
Previous Study | Return to List | Next Study

Tooth and Tissue Sample Collection During Wisdom Teeth Removal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01805869
Recruitment Status : Recruiting
First Posted : March 6, 2013
Last Update Posted : November 11, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )

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.

Condition or disease
Stomatognatic Tooth Diseases Diseases Tooth Tooth Impaction

Detailed Description:

Objective

The objective of this protocol is to evaluate and provide treatment for subjects who have a clinical indication for the routine extraction of dental third molar wisdom teeth with the aim to allow investigators to maintain their expertise in dental clinical care, gain additional knowledge about oral health and to utilize surgical waste collected from these patients for research studies.

Study Population

The protocol will enroll a convenience sample of 10000 subjects ages greater than or equal to 16-50 in need of clinically indicated, routine extraction of third molars.

Design

This is an evaluation, treatment and training protocol. Subjects will receive standard evaluation and treatment for clinically indicated, routine extraction of third molars. Subjects will report to the NIDCR dental clinic for at least three visits. The first visit will be a screening evaluation to determine the clinical need for third molar extraction and protocol eligibility. Eligible subjects will return for a second visit for third molar extraction. Oral specimens removed during the standard procedure of third molar extraction will be distributed for research. A third visit will be scheduled approximately one week after surgery for a post-operative clinical evaluation. Data collection will include demographics, pain management, medication regimen and adverse events to examine its effect on clinical outcomes

Outcome Measures

There is no research planned under this protocol. However, data is collected for purposes of research and clinical quality assurance. If trends emerge that warrant further exploration, outcome measures will be described when IRB approval or determination of exemption is requested to carry out the project.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oral Specimen and Data Acquisition Study of Subjects Requiring Third Molar Removal
Actual Study Start Date : June 19, 2013
Estimated Primary Completion Date : December 31, 2029
Estimated Study Completion Date : December 31, 2029

Group/Cohort
1
Data and surgical waste tissue for research purpose in subjects undergoing clinically indicated wisdom teeth extraction at the NIH NIDCR Dental clinic



Primary Outcome Measures :
  1. data collection [ Time Frame: 9 years ]
    If trends emerge that warrant further exploration, outcome measures will be described



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   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.
Criteria
  • INCLUSION CRITERIA:
  • Ages greater than or equal to 16-50
  • Clinical evidence of need (dental decay, bony or soft tissue impaction, orthodontic need) for third molar extraction as determined by medical, dental, and radiographic evaluation
  • Willing to allow for the collection of waste tissue (e.g., teeth, alveolar bone, excessive gingival tissue) extracted 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01805869


Contacts
Layout table for location contacts
Contact: Sharon Mitchell (301) 496-4372 sharon.mitchell@nih.gov

Locations
Layout table for location information
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Contact: Danielle Elangue    (301) 451-9733    danielle.elangue@nih.gov   
Sponsors and Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Layout table for investigator information
Principal Investigator: Janice S Lee, DDS, MD National Institute of Dental and Craniofacial Research (NIDCR)
Additional Information:
Layout table for additonal information
Responsible Party: National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier: NCT01805869    
Other Study ID Numbers: 130033
13-D-0033
First Posted: March 6, 2013    Key Record Dates
Last Update Posted: November 11, 2021
Last Verified: November 8, 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) ):
Third Molar
Specimen Acquisition
Additional relevant MeSH terms:
Layout table for MeSH terms
Tooth Diseases
Stomatognathic Diseases