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

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ClinicalTrials.gov Identifier: NCT00316485
Recruitment Status : Completed
First Posted : April 20, 2006
Last Update Posted : October 6, 2017
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Tracking Information
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
Change History
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
 
Descriptive Information
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
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.

Detailed Description

OBJECTIVE:

The objective of this protocol is to obtain oral tissue for analysis by various research groups at the National Institutes of Health (NIH).

STUDY POPULATION:

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.

STUDY DESIGN:

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.

OUTCOME MEASURES:

This study does not involve any outcome measurements.

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Wisdom Teeth
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 26, 2011)
718
Original Enrollment
 (submitted: April 19, 2006)
300
Study Completion Date January 28, 2013
Primary Completion Date Not Provided
Eligibility Criteria
  • INCLUSION CRITERIA

<TAB>

  1. Males and females aged 18 to 50 years
  2. Evidence of need for third molar extraction as determined by medical and dental history, as well as clinical and radiographic evaluation
  3. Willing to provide at least one wisdom tooth for research purposes
  4. Willing to provide one or more of the following tissue types for research purposes:

    Excessive gingival tissue around extraction sockets

    Oral tissues from the floor of the mouth, cheek, palate and/or lateral border of the tongue

    Small biopsies of alveolar bone from the sockets that surround the wisdom teeth

  5. America Society of Anesthesiologists (ASA) status I or II

EXCLUSION CRITERIA

  1. Pregnant or nursing
  2. Clinical signs of infection and/or inflammation, or acute pain at any extraction site at the time of the screening evaluation
  3. Known bleeding disorders or conditions associated with bleeding, including Hemophilia, von Willebrand disease, protein C/S deficiency, antithrombin III deficiency, and liver disease.
  4. Currently using anticoagulation (blood thinning) medications, including but not limited to warfarin (Coumadin), ticlopidine (Ticlid) and clopidogril (Plavix). Subjects who are currently taking Aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) may be eligible for enrollment.
  5. Known or suspected allergy or adverse reaction to any of the agents used for local anesthesia, suture material, or conscious sedation medications
  6. Surgical removal of the wisdom teeth is expected to be unusually difficult based on panoramic radiograph. Indicators of unusual difficulty include increased depth of tooth impaction, extreme angulation of a tooth, and close proximity of a tooth to the inferior alveolar nerve canal and/or maxillary sinus.
Sex/Gender
Sexes Eligible for Study: All
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  
 
Administrative Information
NCT Number NCT00316485
Other Study ID Numbers 060144
06-D-0144
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)
Collaborators Not Provided
Investigators
Principal Investigator: Carol W Bassim, D.M.D. National Institute of Dental and Craniofacial Research (NIDCR)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date January 28, 2013