This study will evaluate the effects of the new anti-inflammatory drug, Celebrex, on
relieving pain after oral surgery. It is also designed to assess the drug's selective
inhibition of a chemical called cyclooxygenase-2 and not its closely related form,
cyclooxygenase-1. This selective inhibition allows pain alleviation without the adverse side
effects (e.g., bleeding and stomach upset) often associated with anti-inflammatory drugs.
Healthy volunteers who require removal of their third molars are eligible for this study.
Participants will have oral surgery for tooth extraction after receiving a local anesthetic
(lidocaine) in the mouth and a sedative (midazolam) through an arm vein. On the evening
before and 1 hour before surgery, patients will be given a dose of either the standard
anti-inflammatory drug ibuprofen (Advil, Nuprin, Motrin), or Celebrex, or a placebo (a pill
with no active ingredient). After surgery, a small piece of tubing will be placed in each
extraction site and tied to an adjacent tooth to hold it in place. Samples will be collected
from the tubing to measure chemicals involved in pain and inflammation. Patients will stay in
the clinic for up to 6 hours after surgery while the anesthetic wears off and will complete
pain questionnaires. During that time, they may receive acetaminophen plus codeine (Tylenol
3), if needed, for pain. The tubing then will be removed and the patient discharged with
standard pain medication.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Dental and Craniofacial Research (NIDCR)