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Status:

COMPLETED

Capsaicin to Control Pain Following Third Molar Extraction

Lead Sponsor:

National Institute of Dental and Craniofacial Research (NIDCR)

Conditions:

Healthy

Tooth Extraction

Eligibility:

All Genders

Phase:

PHASE2

Brief Summary

Capsaicin to Control Pain Following Third Molar Extraction Summary: This study will test the effectiveness of the drug capsaicin in controlling pain after third molar (wisdom tooth) extraction. Capsa...

Detailed Description

Successful preemptive analgesic strategies are superior to traditional pain management schemes in the management of post-operative pain. The premise of this double-blind, placebo and positive-controll...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • Male or female volunteers referred for mandibular third molar extraction with a minimal difficulty rating score of 2 - 3 at the time of screening; rating will be verified by the oral surgeon at time of surgery. (Rating scale: 1 = erupted; 2 = soft tissue impaction; 3 = partial bony impaction; 4 = full bony impaction).
  • Age between 16-40.
  • ASA status 1 or 2, deemed in good general health (able to tolerate outpatient conscious sedation safely).
  • Willing to wait up to 4 hours for post-operative observation.
  • Willing to return at 48 hours for a second tissue biopsy.
  • EXCLUSION CRITERIA:
  • ASA status 3-5 and Emergency operation (E) that do not get a physician clearance; i.e. systemic disturbances that limits the patient's activity.
  • Pregnant or breast-feeding mothers.
  • Allergy to investigational drugs or to red chili peppers.
  • Chronic use of analgesics (not limited to, but including: non-steroidal anti-inflammatory medications, steroids, anti-depressants, anti-convulsants).
  • Presence of chronic disease (e.g. cardiovascular disease, liver disease, kidney disease, diabetes, etc.).
  • No exclusions will be made based on race, gender, or religion.

Exclusion

    Key Trial Info

    Start Date :

    July 1 2004

    Trial Type :

    INTERVENTIONAL

    End Date :

    October 1 2005

    Estimated Enrollment :

    75 Patients enrolled

    Trial Details

    Trial ID

    NCT00088686

    Start Date

    July 1 2004

    End Date

    October 1 2005

    Last Update

    March 4 2008

    Active Locations (1)

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    Page 1 of 1 (1 locations)

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    National Institute of Dental And Craniofacial Research (NIDCR)

    Bethesda, Maryland, United States, 20892