Status:
RECRUITING
Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain Management
Lead Sponsor:
University of Colorado, Denver
Conditions:
Pain, Orofacial
Eligibility:
All Genders
12-80 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to compare the effectiveness of a combined ibuprofen and acetaminophen regimen in controlling discomfort for 4 days after initial orthodontic appliance placement as compar...
Detailed Description
Orthodontic pain is often reported for the first 4 days after the appliances are attached. This study will investigate two modes of pain management versus a placebo. Consented subjects will be randoml...
Eligibility Criteria
Inclusion
- scheduled to begin comprehensive orthodontic treatment (banding/bonding of at least 10 teeth in 1 arch and archwire placement in at least 1 arch);
- extractions, if required, performed at least 2 weeks before appliance and archwire placement;
- healthy with no significant medical findings;
- no prophylactic antibiotic coverage required;
- currently not taking antibiotics or analgesics;
- no contraindications to the use of acetaminophen or ibuprofen; and
- minimum age of 12 years
Exclusion
- Under the age of 12 or over the age of 80,
- prisoners,
- pregnant women,
- decisionally challenged individuals,
- allergy to either medication,
- history of kidney disease,
- liver damage or disease,
- alcoholism/use of 3 or more alcoholic drinks during study period,
- use of blood thinners,
- stomach ulcers or
- stomach bleeding.
Key Trial Info
Start Date :
December 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT04059172
Start Date
December 10 2019
End Date
January 1 2028
Last Update
April 2 2025
Active Locations (1)
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1
University of Colorado, School of Dental Medicine
Aurora, Colorado, United States, 80045