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

Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain of Initial Orthodontic Wire Insertion: a Randomized Controlled Trial

Who can join

Ages 12 to 80 · All sexes · Healthy volunteers welcome

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.

About the study

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.

What is being tested

• Ibuprofen 200 mg and acetaminphen 650 mg (drug)
• Ibuprofen 200 mg (drug)
• Placebo oral tablet (drug)

Sponsor: University of Colorado, Denver · Participants: 375 · Started: Dec 10, 2019

Contact the study team

• Clifton M Carey, PhD · Phone: 3037241046

Official record on ClinicalTrials.gov — NCT04059172

Locations in the U.S.

Conditions

• Facial Pain

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.