Cyclooxygenase Levels Following Surgery to Remove Third Molars (Wisdom Teeth)

NCT00006175 | Completed

• 2 other identifiers: 00019000-D-0190
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Inflammation

Keywords

Cyclooxygenase; COX-1; COX-2; Prostanoids; P.C.R.; Healthy Volunteer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Dental and Craniofacial Research (NIDCR): lead

Study Sites (1)

National Institute of Dental And Craniofacial Research (NIDCR)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 9789085 BACKGROUND

• 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.

  PMID: 9831330 BACKGROUND

• 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.

  PMID: 10440619 BACKGROUND

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 12, 2000
• First Posted: August 14, 2000
• Study Start: August 1, 2000
• Study Completion: October 1, 2005
• Last Updated: March 4, 2008

Record last verified: 2005-10

Locations

US (1)