- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006175
Cyclooxygenase Levels Following Surgery to Remove Third Molars (Wisdom Teeth)
Cytokine Responses to Acute Inflammation in the Oral Surgery Model
This study will measure levels of an enzyme called cyclooxygenase in gum tissue following third molar (wisdom tooth) extraction. Cyclooxygenase is thought to contribute to pain that normally follows tissue injury or surgery.
Healthy volunteers between 16 and 35 years of age who require removal of their third molars may be eligible for this study. Participants will receive an injection of a local anesthetic (lidocaine) in the mouth and a sedative (midazolam) through an arm vein before surgery. Before the tooth is removed, a small tissue sample (biopsy) will be collected from the gum tissue covering one of the lower third molars to be extracted. After surgery, a second biopsy will be taken at some point between just after surgery to the time when pain from the extraction starts to develop. These tissue samples will be analyzed for cyclooxygenase levels.
Patients will stay in the clinic for up to 4 hours after surgery while the anesthetic wears off. During this time, they will complete pain questionnaires. If needed, patients may receive additional medicine for pain relief at any time during the surgery or the 4-hour observation period. They will also be given standard pain medication to take home at the end of the study.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institute of Dental and Craniofacial Research (NIDCR)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
Subjects will be healthy volunteers between the ages 16-35 years presenting to the Clinical Center for removal of their third molars.
The type of third molar will be characterized at the time of screening by oral exam and panoramic radiograph:
- Erupted tooth: Clinical crown is present in the mouth and is not covered by soft tissue.
- Soft tissue impaction: Clinical crown is not present in the mouth but the adjacent alveolar bone does not cover any portion of the crown in the radiograph.
- Partial bony impaction: Clinical crown is not present in the mouth and the alveolar bone covers some but not all of the crown in the radiograph.
- Full bony impaction: Clinical crown is not present in the mouth and the alveolar bone covers most or all of the crown in the radiograph.
Patients will be eligible for inclusion in this study if the two mandibular molars are classified as partial or full bony impactions.
EXCLUSION CRITERIA:
Patients who are pregnant or nursing.
Presence of infection or inflammation [pericoronitis] at either extraction site.
Patients who are taking any of the following drugs: anti-depressants, diuretics, aspirin on a near daily basis, coumadin or other blood thinners; or other drugs that might influence pain report or COX formation, e.g. steroids.
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- Smith CJ, Zhang Y, Koboldt CM, Muhammad J, Zweifel BS, Shaffer A, Talley JJ, Masferrer JL, Seibert K, Isakson PC. Pharmacological analysis of cyclooxygenase-1 in inflammation. Proc Natl Acad Sci U S A. 1998 Oct 27;95(22):13313-8. doi: 10.1073/pnas.95.22.13313.
- Pairet M, van Ryn J. Experimental models used to investigate the differential inhibition of cyclooxygenase-1 and cyclooxygenase-2 by non-steroidal anti-inflammatory drugs. Inflamm Res. 1998 Oct;47 Suppl 2:S93-101. doi: 10.1007/s000110050289.
- Morrison BW, Christensen S, Yuan W, Brown J, Amlani S, Seidenberg B. Analgesic efficacy of the cyclooxygenase-2-specific inhibitor rofecoxib in post-dental surgery pain: a randomized, controlled trial. Clin Ther. 1999 Jun;21(6):943-53. doi: 10.1016/S0149-2918(99)80016-2.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 000190
- 00-D-0190
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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