Diagnosis, Evaluation and Treatment of Patients in Need of Third Molar Removal

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00316485
First received: April 19, 2006
Last updated: February 19, 2014
Last verified: January 2013
  Purpose

Under this study, patients who require removal of their third molars (wisdom teeth) will be diagnosed, evaluated and treated. In addition, tooth, bone and gum tissue samples will be collected for use in bone, wound healing, microbiology and genetic research.

Patients 16-50 years of age who require wisdom tooth removal may be eligible for this study. Participants may have one or all of their wisdom teeth removed at one time. The surgery is done under local anesthetic. In addition, conscious sedation may be administered, if the patient wishes.

Besides wisdom tooth removal, patients are asked to donate a small sample of jaw bone (from the lining of the inner wall of the tooth socket) and gum tissue (from the area of the surgical site). The samples are collected at the same time as the tooth extraction. The bone sample is about the size of a pencil point (1.5 millimeters wide and 3 millimeters long) and the gum tissue sample is 1 millimeter. Removal of these samples should not cause any additional discomfort or increase the time required for the surgery or for healing.


Condition
Wisdom Teeth

Study Type: Observational
Official Title: Diagnosis, Evaluation and Treatment of Patients in Need of Third Molar Removal

Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 718
Study Start Date: April 2006
Estimated Study Completion Date: January 2013
Detailed Description:

OBJECTIVE:

The objective of this protocol is to obtain oral tissue for analysis by various research groups at the National Institutes of Health (NIH).

STUDY POPULATION:

The protocol will enroll a convenience sample of 1,000 subjects between the ages of 18 to 50 years who are in need of third molar (wisdom tooth) extraction.

STUDY DESIGN:

Subjects will report to the National Institutes of Dental and Craniofacial Research (NIDCR) for up to three visits. The first study visit will involve a screening evaluation to determine protocol eligibility. Eligible subjects will be invited back for a second visit for wisdom tooth extraction and collection of oral tissue for research purposes. All subjects will remain on the protocol for three weeks after surgery, and they will have the option to schedule a follow-up visit to the NIH for post-operative evaluation.

OUTCOME MEASURES:

This study does not involve any outcome measurements.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA

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  1. Males and females aged 18 to 50 years
  2. Evidence of need for third molar extraction as determined by medical and dental history, as well as clinical and radiographic evaluation
  3. Willing to provide at least one wisdom tooth for research purposes
  4. Willing to provide one or more of the following tissue types for research purposes:

    Excessive gingival tissue around extraction sockets

    Oral tissues from the floor of the mouth, cheek, palate and/or lateral border of the tongue

    Small biopsies of alveolar bone from the sockets that surround the wisdom teeth

  5. America Society of Anesthesiologists (ASA) status I or II

EXCLUSION CRITERIA

  1. Pregnant or nursing
  2. Clinical signs of infection and/or inflammation, or acute pain at any extraction site at the time of the screening evaluation
  3. Known bleeding disorders or conditions associated with bleeding, including Hemophilia, von Willebrand disease, protein C/S deficiency, antithrombin III deficiency, and liver disease.
  4. Currently using anticoagulation (blood thinning) medications, including but not limited to warfarin (Coumadin), ticlopidine (Ticlid) and clopidogril (Plavix). Subjects who are currently taking Aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) may be eligible for enrollment.
  5. Known or suspected allergy or adverse reaction to any of the agents used for local anesthesia, suture material, or conscious sedation medications
  6. Surgical removal of the wisdom teeth is expected to be unusually difficult based on panoramic radiograph. Indicators of unusual difficulty include increased depth of tooth impaction, extreme angulation of a tooth, and close proximity of a tooth to the inferior alveolar nerve canal and/or maxillary sinus.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316485

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Carol W Bassim, D.M.D. National Institute of Dental and Craniofacial Research (NIDCR)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00316485     History of Changes
Other Study ID Numbers: 060144, 06-D-0144
Study First Received: April 19, 2006
Last Updated: February 19, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Bone
Microbiology
Dental Pulp Stem Cell
Wisdom Teeth
Biopsy
Third Molar Extraction

ClinicalTrials.gov processed this record on July 22, 2014