The purpose of this research study is to compare pain control effectiveness of two medicines and a placebo (a dummy pill that does not contain any pain relieving medication) to see which one works better at preventing pain when taken both 1 hour before and 6 hours after orthodontic separators are placed. The research hypothesis is that there will be a significant difference in pain as measured by...
Date First Received: June 7, 2007
Last Updated: June 20, 2007
Verified by: University of Missouri, Kansas City, June 2007
Clinical Trial Phase: Phase 4 | Start Date: June 2007
Overall Status: Recruiting
Estimated Enrollment: 93
Brief Summary
Official Title: “Acetaminophen Versus Ibuprofen for the Control of Immediate and Delayed Pain Following Orthodontic Separator Placement”
Condition Keyword(s):
Intervention(s):
The purpose of this research study is to compare pain control effectiveness of two medicines and a placebo (a dummy pill that does not contain any pain relieving medication) to see which one works better at preventing pain when taken both 1 hour before and 6 hours after orthodontic separators are placed. The research hypothesis is that there will be a significant difference in pain as measured by Visual Analogue Scales (VAS) over time and that this effect will differ for acetaminophen versus ibuprofen.
Study Type: Interventional
Study Design: Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Outcome Measures for this Clinical Trial
Primary:
- Pain/discomfort levels reported on Visual Analogue Scales Assessments conducted at six intervals during a 24 hour period
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Orthodontic treatment requires banding of posterior teeth
- Orthodontic treatment requires the placement of two or more separators
- Able to swallow analgesic pills
- English speaking
- Age 9-17
- Minimum weight requirement of 88 pounds
Exclusion Criteria:
- Orthodontic appliances are present in the mouth
- Use of acetaminophen or ibuprofen is contraindicated (allergy, GI problems)
- Antibiotics or analgesics are currently in use
- History of systemic disease exists (arthritis, diabetes, cystic fibrosis)
- Significant cognitive impairment
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: University of Missouri, Kansas City
Orthodontic office of Drs. Dan Blackwell, Beth Blackwell-Nill, Scott Francois
Lee's Summit Missouri 64063 United States
Orthodontic office of Dr. James Osborne
Lee's Summit Missouri 64082 United States
Overall Clinical Trial Officials and Contacts
Shelliann A Kawamoto, DDS Principal Investigator University of Missouri-Kansas City School of Dentistry Department of Orthodontics and Dentofacial Orthopedics
Overall Contact: Shelliann A Kawamoto, DDS 816-235-2141 sak427@umkc.edu
Additional Information
Information obtained from ClinicalTrials.gov on July 23, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00484744
Study ID Number: 07 04-054
ClinicalTrials.gov Identifier: NCT00484744
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
