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

Phase 4

Completed

• Conditions: Orthodontic Pain
• Interventions: Drug: Avicel (placebo); Drug: Acetaminophen; Drug: Ibuprofen

• Registration Number: NCT00484744
• Lead Sponsor: University of Missouri, Kansas City

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-07
• Study First Submitted QC: 2007-06-07
• Study First Posted: 2007-06-11
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-19
• Last Update Posted: 2020-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Avicel	Avicel (placebo)	-
Acetaminophen	Acetaminophen	-
Ibuprofen	Ibuprofen	-

Primary Outcome Measures

Name	Time	Method
Pain/discomfort levels reported on Visual Analogue Scales	Assessments conducted at six intervals during a 24 hour period

Trial Locations

Locations (2)

Orthodontic office of Drs. Dan Blackwell, Beth Blackwell-Nill, Scott Francois; 🇺🇸 Lee's Summit, Missouri, United States

Orthodontic office of Dr. James Osborne; 🇺🇸 Lee's Summit, Missouri, United States