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Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain Management

RecruitingEARLY Phase 1Ages 12 Years - 80 YearsAllUniversity of Colorado, Denver
NCT04059172 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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.
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What it tests

  • Ibuprofen 200 mg and acetaminphen 650 mg
  • Ibuprofen 200 mg
  • Placebo oral tablet
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Where

1 site
University of Colorado, School of Dental Medicine
Aurora, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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