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NCT04059172EARLY_PHASE1RecruitingAccepts Healthy Volunteers

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

University of Colorado, Denver

Start Date

12/10/2019

Completion Date

6/1/2028

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 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.

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 randomly assigned to one of 3 groups: Group A, a combined and simultaneous therapy of 200 mg ibuprofen and 650 mg acetaminophen (3 pills total) taken orally at set time intervals (0 h, 6 h, 12 h, and 24h, 48h, 72h, and 96h); Group B, ibuprofen alone (200 mg) taken orally at same time intervals (1 ibuprofen and 2 placebo pills); Group C, placebo taken orally at the same time intervals (3 placebo pills). The study will be blinded for the investigators, patients, and statisticians.

Eligibility Criteria

Age Range: 12 years to 80 years

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.

Interventions

DRUG

Ibuprofen 200 mg and acetaminphen 650 mg

DRUG

Ibuprofen 200 mg

DRUG

Placebo oral tablet

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Conditions

Pain, Orofacial

Locations

University of Colorado, School of Dental Medicine

Aurora, Colorado 80045

United States