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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Orthodontic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Acetaminophen

Group Type EXPERIMENTAL

Acetaminophen

Intervention Type DRUG

Ibuprofen

Group Type EXPERIMENTAL

Ibuprofen

Intervention Type DRUG

Avicel

Group Type PLACEBO_COMPARATOR

Avicel (placebo)

Intervention Type DRUG

Interventions

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Acetaminophen

Intervention Type DRUG

Avicel (placebo)

Intervention Type DRUG

Ibuprofen

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

9 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes