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
Intervention(s) in this Clinical Trial
- Drug: Acetaminophen, Ibuprofen, Avicel (placebo)
Outcome Measures for this Clinical Trial
Primary Measures
- Pain/discomfort levels reported on Visual Analogue Scales
- Time Frame: Assessments conducted at six intervals during a 24 hour period
- Time Frame: 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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 9 Years
Maximum Age for this Clinical Trial: 17 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: University of Missouri, Kansas City
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 02, 2009
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
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