Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain of Initial Orthodontic Wire Insertion: a Randomized Controlled Trial
Overview
- Phase
- Early Phase 1
- Intervention
- Ibuprofen 200 mg
- Conditions
- Pain, Orofacial
- Sponsor
- University of Colorado, Denver
- Enrollment
- 375
- Locations
- 1
- Primary Endpoint
- Change in visual analogue score (VAS) over time
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility 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
Arms & Interventions
Ibuprofen
one 200 mg tablet of ibuprofen and 2 placebo tablets
Intervention: Ibuprofen 200 mg
Ibuprofen and acetaminophen
one 200 mg table of ibuprofen and two 325 mg tablets of acetaminophen
Intervention: Ibuprofen 200 mg and acetaminphen 650 mg
Placebo
3 tablets of tableting compounds with no active ingredients
Intervention: Placebo oral tablet
Outcomes
Primary Outcomes
Change in visual analogue score (VAS) over time
Time Frame: 0 hours, 6 hours, 12 hours, and 24 hours, 48 hours, 72 hours, and 96 hours after placement of appliances
Primary outcomes with be the pain values recorded by subjects when chewing on the 100-mm VAS at set times.The VAS line for each time period will be 100 mm long with no intermediate delineations. Each end will be marked with "no pain" on the left, and "worst possible pain" on the right.
Secondary Outcomes
- Dosing Compliance(to be recorded at 0 hours, 6 hours, 12 hours, and 24 hours, 48 hours, 72 hours, and 96 hours after placement of appliances.)