Status:
COMPLETED
Bradykinin Receptors and Pain
Lead Sponsor:
National Institute of Nursing Research (NINR)
Conditions:
Tooth, Impacted
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
This study will examine whether bradykinin receptors are produced at the site of wisdom tooth extraction and if they contribute to the amount of inflammation and pain that follows surgery. Bradykinin ...
Detailed Description
Bradykinin B1 receptors and their natural agonists are known to be rapidly induced in local tissues by a variety of inflammatory stimuli. Preclinical evidence, demonstrating that interruption of B1 re...
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 a possible 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 at 3, 7 or 24 hours following surgery
- Willing to return, if needed, 24 hours post-operation for the postoperative biopsy
- Must have two lower partial (rating is equal to 3) or fully impacted (rating is equal to 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 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
- Unusual surgical difficulty (determined from panoramic radiograph or during the actual surgery)
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00083356
Start Date
May 1 2004
End Date
February 1 2006
Last Update
March 4 2008
Active Locations (1)
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1
National Institute of Nursing Research (NINR)
Bethesda, Maryland, United States, 20892