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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 19, 2006 | ||||||||
| Last Updated Date | August 24, 2009 | ||||||||
| Start Date ICMJE | April 2006 | ||||||||
| Estimated Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00316485 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Diagnosis, Evaluation and Treatment of Patients in Need of Third Molar Removal | ||||||||
| Official Title ICMJE | Diagnosis, Evaluation and Treatment of Patients in Need of Third Molar Removal | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE | Wisdom Teeth | ||||||||
| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 1000 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
EXCLUSION CRITERIA
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| Gender | Both | ||||||||
| Ages | 16 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00316485 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 060144, 06-D-0144 | ||||||||
| Study Sponsor ICMJE | National Institute of Dental and Craniofacial Research (NIDCR) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | March 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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