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NCT00088686 · ClinicalTrials.gov registry record · Phase 2
Capsaicin to Control Pain Following Third Molar Extraction
A Phase 2 study of Healthy and Tooth Extraction, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT00088686 is a Phase 2 study of Healthy and Tooth Extraction that has completed, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 75 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00088686, a Phase 2 study of Healthy and Tooth Extraction, has completed, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study 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. Capsaicin, the ingredient in chili peppers that makes them "hot," belongs to a class of drugs called vanilloids, which have been found to temporarily inactivate pain-sensing nerves. If capsaicin alleviates pain in dental surgery, it may have potential for use in many types of surgery and painful illnesses. Healthy normal volunteers between 16 and 40 years of age who require third molar (wisdom tooth) extraction may be eligible for this study. Participants undergo the following procedures in three visits: Visit 1 Patients have touch (sensory) testing inside the mouth using three methods: 1) applying a temperature probe onto the gums and having the patient rate how warm it is; 2) applying a gentle stroke across the gums with the bristles of a small paint brush and having the patient say whether or not it feels painful; and 3) applying a light touch to the gums with a small needle and having the patient rate the pain intensity following the touch. Following touch testing, the patient's mouth is numbed with an anesthetic and a small piece of gum tissue next to the lower wisdom tooth is removed (biopsied). Then, a small amount of either capsaicin or placebo (saline, or salt water) is injected next to the wisdom tooth. Visit 2 Following repeat the touch testing, patients are sedated with an injection of midazolam. They then have another biopsy under local anesthesia on the same side of the mouth as the first biopsy. Their mouth is again numbed with an anesthetic, and they are given either a pain-relieving medicine called Toradol or a placebo injected into the arm. One lower wisdom tooth is then extracted. After the extraction, pain ratings are recorded every 20 minutes for up to 6 hours. During this time, patients are monitored for vital signs, numbness, pain, and side effect
Conditions Studied
Interventions
- DRUG Capsaicin (Intramucosal Injection)
Study Locations (1)
Maryland
- National Institute of Dental And Craniofacial Research (NIDCR) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2004-07 |
| Est. Completion | 2005-10 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00088686
The ClinicalTrials.gov registry entry for NCT00088686 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (88% lower). The listed sponsor is National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which Capsaicin (Intramucosal Injection) is the first listed.
NCT00088686 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00088686 about?
NCT00088686 is a clinical study titled "Capsaicin to Control Pain Following Third Molar Extraction". 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. Capsaicin, the ingredient in chili peppers that makes them "hot," belongs to a class of drugs called vani...
What is the current status of trial NCT00088686?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2004-07. Estimated completion is 2005-10.
What conditions does trial NCT00088686 study?
This clinical trial studies the following conditions: Healthy, Tooth Extraction.
What interventions are being tested in trial NCT00088686?
The interventions under investigation include: Capsaicin (Intramucosal Injection) (DRUG).
Who is sponsoring clinical trial NCT00088686?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00088686 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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