Diagnosis, Evaluation and Treatment of Patients in Need of Third Molar Removal
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00316485|
Recruitment Status : Completed
First Posted : April 20, 2006
Last Update Posted : October 6, 2017
|First Submitted Date||April 19, 2006|
|First Posted Date||April 20, 2006|
|Last Update Posted Date||October 6, 2017|
|Study Start Date||April 14, 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title||Diagnosis, Evaluation and Treatment of Patients in Need of Third Molar Removal|
|Official Title||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.
The objective of this protocol is to obtain oral tissue for analysis by various research groups at the National Institutes of Health (NIH).
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.
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.
This study does not involve any outcome measurements.
|Study Design||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Study Completion Date||January 28, 2013|
|Primary Completion Date||Not Provided|
|Ages||18 Years to 50 Years (Adult)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||060144
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor||National Institute of Dental and Craniofacial Research (NIDCR)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||January 28, 2013|