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

• Status: Active, not recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: Acetaminophen; Ibuprofen

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.