Status:
COMPLETED
Prostanoid Levels After Medication to Prevent Pain Following Third Molar (Wisdom Tooth) Extraction
Lead Sponsor:
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Healthy
Tooth Extraction
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
This study will evaluate how well different medications work to relieve pain following third molar (wisdom tooth) extraction. Scientists believe that hormone-like substances called prostanoids contrib...
Detailed Description
Two cyclooxygenase isozymes, COX-1 and -2, are known to catalyze the rate-limiting step of prostaglandin synthesis and are the targets of nonsteroidal anti-inflammatory drugs. Recently, the presence o...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Male or female volunteers referred for third molar extraction willing to undergo 2 or 3 visits: 1 screening visit; 1 surgical appointment; and possible 1 follow-up research-related appointment
- Between the ages of 16 to 35 years (based upon eruption patterns and age-related complications associated with surgical extraction of third molars)
- In general good health- American Society of Anesthesiologists (ASA) status I or II (healthy subjects based upon criteria for safe administration of out-patient conscious sedation)
- Willing to undergo observation period for three hours postoperatively
- Ability to complete a 100 mm visual analog scale and a category scale every 20 minutes for the first 3 postoperative hours
- Willing to have a microdialysis probe placed beneath the surgical flap during the first 3 hours post-surgery
- Willing to have a preoperative biopsy on the day of surgery, and a postoperative biopsy either within 3 hours or at 24 hours following surgery
- Willing to return, if needed, 24 hours post-operation for the postoperative biopsy
- Must have two lower partial bony impacted wisdom teeth fully covered by intact soft tissue (rating equals 3) or fully bony impacted (rating equals 4) wisdom teeth (mandibular third molars)
- As assessed at the screening visit, the sum of the mandibular third molar surgical difficulty ratings must be between 6 to 8 in order to evaluate subjects experiencing similar pain levels
- EXCLUSION CRITERIA:
- Patients who are allergic to aspirin, NSAIDs, sulfites, or amide anesthetics
- Patients who have had asthma, or hives
- Patients who are pregnant or nursing
- Patients with history of peptic ulcers and/or GI bleeding
- Chronic use of medications confounding the assessment of the inflammatory response or analgesia, for example, NSAIDs, COX-2 inhibitors, antihistamines, steroids, antidepressants
- Patients who have significant psychiatric history
- Patients who have a clinical signs suggestive of infection, inflammation, or pre-existing pain at either extraction site
- Patients with severe kidney disease
- Patients who are taking any of the following drugs: ACE inhibitor; potassium sparing diuretics; aspirin on a near daily basis; coumadin or other blood thinners
- Patients who are taking drugs known to inhibit P450 2C9 and drugs metabolized by P450 2D6
- Patients who have G6PD deficiency and those taking St. John's Wort
- Unusual surgical difficulty (determined from panoramic radiograph or during the actual surgery)
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT00078104
Start Date
February 1 2004
End Date
October 1 2005
Last Update
March 4 2008
Active Locations (1)
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1
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, United States, 20892