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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Orthodontic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

9 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetaminophen

Drug

Avicel (placebo)

Drug

Ibuprofen

Drug

Primary outcomes

Pain/discomfort levels reported on Visual Analogue Scales

Time frame: Assessments conducted at six intervals during a 24 hour period

Sponsors and collaborators

Lead sponsor

University of Missouri, Kansas City

Other

Registry information

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Jun 11, 2007
Registry last updated: Aug 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed