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Diagnosis, Evaluation and Treatment of Patients in Need of Third Molar Removal
This study is currently recruiting participants.
Study NCT00316485   Information provided by National Institutes of Health Clinical Center (CC)
First Received: April 19, 2006   Last Updated: August 24, 2009   History of Changes

April 19, 2006
August 24, 2009
April 2006
April 2009   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00316485 on ClinicalTrials.gov Archive Site
 
 
 
Diagnosis, Evaluation and Treatment of Patients in Need of Third Molar Removal
Diagnosis, Evaluation and Treatment of Patients in Need of Third Molar Removal

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.

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

Each individual will undergo a thorough oral evaluation during the screening process, including a review of current and past medical histories and a 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 constitute 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 options for participation in this study. If they choose not to participate in the study, recommendations of the other treatment opportunities may be given to the individual, to their primary dentist/physician, or to the referring dentist/physician.

Consenting subjects will undergo removal of one to four wisdom teeth using standard surgical procedures. The following tissues may be obtained for use in laboratory studies of NIDCR investigators: one to four wisdom teeth, small samples of oral mucosa, small biopsies of alveolar bone from the mandibular and/or the maxillary sockets that surrounded 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.

 
Observational
 
Wisdom Teeth
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
1000
 
April 2009   (final data collection date for primary outcome measure)
  • 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 signs of infection, inflammation, or pre-existing pain at the extraction site(s)
  3. Patients who are taking warfarin or other anticoagulant therapy.
  4. Patients who may require unusually difficult surgical removal of the wisdom teeth (determined from panoramic radiograph or during actual surgery).
Both
16 Years to 50 Years
Yes
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010
United States
 
NCT00316485
 
060144, 06-D-0144
National Institute of Dental and Craniofacial Research (NIDCR)
 
 
National Institutes of Health Clinical Center (CC)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP