Tooth, Impacted Clinical Trial
Official title:
Bradykinin-1 Receptor and Kinin Induction in a Clinical Model of Tissue Injury
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 is a molecule produced by enzymes at the site of an injury and then
binds to receptors to cause pain. The study will also evaluate the role of genetic factors
in the production of bradykinin and their receptors and the pain associated with minor
surgical procedures.
Patients between 16 and 35 years of age who are referred to the NIH dental clinic for
removal of two wisdom teeth may be eligible for this study. Candidates must be in good
health and must not be allergic to aspirin, non-steroidal anti-inflammatory drugs, sulfites,
or amide anesthetics. They will be screened with a medical history and oral examination,
including x-rays to confirm the need for wisdom tooth extraction.
On the morning of surgery following an overnight fast, participants have a blood sample
drawn to extract DNA for gene studies. Just before surgery, they are given an intravenous
(IV) sedative to induce drowsiness and a local anesthetic to numb the mouth. They are also
given IV either Ketorolac, a non-steroidal anti-inflammatory drug, or placebo, a look-alike
medication with no active ingredient. After the extractions, a small piece of plastic tubing
is placed in both extraction sites, and every 20 minutes for the next 3 hours inflammatory
fluid is collected from the tubing for measuring chemicals believed to cause pain and
swelling. Patients rate their pain by answering pain-related questions every 20 minutes.
Patients who have pain that is not relieved by the study medication (Ketorolac or placebo)
are given, upon request, 50 mg of the pain reliever tramadol (Ultram). Patients remain in
the clinic for at least 3 hours and no more than 7 hours after surgery in order for
monitoring the effects of the study drugs as the local anesthetic wears off.
Patients undergo two biopsies during the study - one before and one after the extraction -
to measure any changes in chemicals produced in response to the surgery. The second biopsy
is done either 3, 7, or 24 hours after the extraction. Patients in the 3- and 7-hour groups
are given a small dose of local anesthetic in the gum for the second biopsy and remain in
the clinic until the biopsy is done; those in the 24-hour group are given forms to record
pain ratings at home and return to the clinic the following morning for a 2-hour follow-up
visit. All patients are given standard pain medication (flurbiprofen) to take at home.
Status | Completed |
Enrollment | 90 |
Est. completion date | February 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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) |
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | National Institute of Nursing Research (NINR) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Nursing Research (NINR) |
United States,
Ahluwalia A, Perretti M. B1 receptors as a new inflammatory target. Could this B the 1? Trends Pharmacol Sci. 1999 Mar;20(3):100-4. — View Citation
Bock MG, Longmore J. Bradykinin antagonists: new opportunities. Curr Opin Chem Biol. 2000 Aug;4(4):401-6. Review. — View Citation
Walker K, Perkins M, Dray A. Kinins and kinin receptors in the nervous system. Neurochem Int. 1995 Jan;26(1):1-16; discussion 17-26. Review. — View Citation
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