Actively Recruiting
Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain Management
Led by University of Colorado, Denver · Updated on 2026-05-14
375
Participants Needed
1
Research Sites
442 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 compared to ibuprofen alone or a placebo. The hypothesis is that combined ibuprofen and acetaminophen therapy will effectively provide better pain control than ibuprofen alone or a placebo after orthodontic appliance placement.
CONDITIONS
Official Title
Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled to begin comprehensive orthodontic treatment with banding/bonding of at least 10 teeth in one arch and archwire placement in at least one arch
- Extractions, if needed, completed at least 2 weeks before appliance and archwire placement
- Healthy with no significant medical findings
- No need for prophylactic antibiotic coverage
- Not currently taking antibiotics or analgesics
- No contraindications to acetaminophen or ibuprofen
- At least 12 years old
You will not qualify if you...
- Under 12 years old or over 80 years old
- Prisoners
- Pregnant women
- Decisionally challenged individuals
- Allergy to ibuprofen or acetaminophen
- History of kidney disease
- Liver damage or disease
- Alcohol use of 3 or more drinks during the study period
- Use of blood thinners
- Stomach ulcers
- Stomach bleeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Colorado, School of Dental Medicine
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
C
Clifton M Carey, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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