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

This study has been suspended.

Sponsored by: National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00316485
  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

U.S. FDA Resources

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):

Estimated Enrollment:   600
Study Start Date:   April 2006

Detailed Description:

This protocol is designed to diagnose, evaluate and treat individuals in need of third molar (wisdom teeth) removal to obtain teeth, bone and soft tissues for further research studies.

Each individual will have a thorough evaluation during the screening process, including a review of the current and past medical history, and an appropriate limited physical examination as indicated. Other routine diagnostic procedures and tests may be performed to determine a subject's eligibility for this protocol. These tests and procedures are of minimal risk and will be expressed in more detail in Section III, Study Procedures.

Once the evaluation process is completed and eligibility is determined, the subjects will be informed of their option to participate in this study. If they choose not to participate in the study, recommendations for other treatment opportunities may be given to the individual, their primary dentist/physician, or referring dentist/physician.

Consenting subjects will have from one to four wisdom teeth removed using standard surgical procedures. One or more of the following tissues will be obtained for use in laboratory studies of NIDCR investigators: one to four wisdom teeth, small fragments of oral mucosa, small biopsies of alveolar bone from the mandibular and/or the maxillary sockets that contained the wisdom teeth, and excess gingival tissues from the extraction sockets. All subjects will be monitored after the surgical procedures and will receive post-operative care as needed.

  Eligibility
Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria
  • INCLUSION CRITERIA

    1. Both male and female volunteers referred for third molar extraction
    2. Patients who are between the ages of 16 to 50 years
    3. Patients who are in general good health - American Society of Anesthesiologists (ASA) status I or II (healthy subjects based upon criteria for safe administration of out-patient conscious sedation)

EXCLUSION CRITERIA

  1. Patients who are pregnant or nursing
  2. Patients who have a clinical sign suggestive of infection, inflammation, or pre-existing pain at extraction site(s)
  3. Patients who are taking warfarin or other anticoagulant therapy.
  4. Patients who have unusual surgical difficulty (determined from panoramic radiograph or during actual surgery)
  Contacts and Locations

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
  More Information


NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   060144, 06-D-0144
First Received:   April 19, 2006
Last Updated:   July 18, 2008
ClinicalTrials.gov Identifier:   NCT00316485
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
Wisdom Teeth

ClinicalTrials.gov processed this record on October 15, 2008




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