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

This study is currently recruiting patients

Verified by National Institutes of Health Clinical Center (CC) April 2006

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

Study Type: Observational
Study Design: Natural History

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):

Expected Total Enrollment:  300

Study start: April 2006

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   -   50 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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)

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00316485

Patient Recruitment and Public Liaison Office      (800) 411-1222    prpl@mail.cc.nih.gov
TTY      1-866-411-1010 

Maryland
      National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda,  Maryland,  20892,  United States; Recruiting

More Information

NIH Clinical Center Detailed Web Page

Publications

Kolenbrander PE, Egland PG, Diaz PI, Palmer RJ Jr. Genome-genome interactions: bacterial communities in initial dental plaque. Trends Microbiol. 2005 Jan;13(1):11-5.

Study ID Numbers:  060144; 06-D-0144
Last Updated:  December 14, 2006
Record first received:  June 19, 2006
ClinicalTrials.gov Identifier:  NCT00316485
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-12-26





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