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RecruitingAccepts healthy volunteersEarly Phase 1

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

University of Colorado, Denver · NCT04059172

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 12–80 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Early Phase 1
Target enrollment
375
US sites recruiting
1
Study start
December 10, 2019
Record last updated
May 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Ibuprofen 200 mg and acetaminphen 650 mg; Ibuprofen 200 mg; Placebo oral tablet

Conditions: Pain, Orofacial

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • University of Colorado, School of Dental Medicine

    Aurora, CO 80045

    Site contact: Clifton Carey, PhD · 303-724-1046 · clifton.carey@ucdenver.edu

Study contacts (from the official record)

  • Clifton M Carey, PhD · 3037241046 · clifton.carey@cuanschutz.edu
All healthy volunteers studies in Colorado →
Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus… (NCT04059172) | Bored Studies