Acetaminophen Versus Ibuprofen for the Control of Immediate and Delayed Pain Following Orthodontic Separator Placement
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...
Brief Summary
Official Title: “Acetaminophen Versus Ibuprofen for the Control of Immediate and Delayed Pain Following Orthodontic Separator Placement”
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind
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 Investigator Information
Lead Investigator: University of Missouri, Kansas City Other
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 February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00484744
