Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT00078104
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00078104
Study Brief:
Protocol Section:
NCT00078104