Acetaminophen Versus Ibuprofen for the Control of Immediate and Delayed Pain Following Orthodontic Separator Placement

University of Missouri, Kansas City

Status and phase: Completed; Phase 4

Conditions: Orthodontic Pain

Treatments: Drug: Ibuprofen; Drug: Avicel (placebo); Drug: Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT00484744

07 04-054

Details and patient eligibility

About

The purpose of this research study is to compare pain control effectiveness of two medicines and a placebo (a dummy pill that does not contain any pain relieving medication) to see which one works better at preventing pain when taken both 1 hour before and 6 hours after orthodontic separators are placed. The research hypothesis is that there will be a significant difference in pain as measured by Visual Analogue Scales (VAS) over time and that this effect will differ for acetaminophen versus ibuprofen.

Enrollment: 35 patients

Sex: All

Ages: 9 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Orthodontic treatment requires banding of posterior teeth
• Orthodontic treatment requires the placement of two or more separators
• Able to swallow analgesic pills
• English speaking
• Age 9-17
• Minimum weight requirement of 88 pounds

Exclusion criteria

• Orthodontic appliances are present in the mouth
• Use of acetaminophen or ibuprofen is contraindicated (allergy, GI problems)
• Antibiotics or analgesics are currently in use
• History of systemic disease exists (arthritis, diabetes, cystic fibrosis)
• Significant cognitive impairment

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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35 participants in 3 patient groups, including a placebo group

Acetaminophen

Experimental group

Treatment:

Drug: Acetaminophen

Ibuprofen

Experimental group

Treatment:

Drug: Ibuprofen

Avicel

Placebo Comparator group

Treatment:

Drug: Avicel (placebo)