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

Orthodontic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00484744
• Other study ID #: 07 04-054
• Status: Completed
• Phase: Phase 4
• Start date: June 2007
• Est. completion date: January 2008

Study information

• Verified date: August 2020
• Source: University of Missouri, Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Orthodontic Pain

Intervention

Drug:
• Acetaminophen

• Avicel (placebo)

• Ibuprofen

Locations

Country	Name	City	State
United States	Orthodontic office of Dr. James Osborne	Lee's Summit	Missouri
United States	Orthodontic office of Drs. Dan Blackwell, Beth Blackwell-Nill, Scott Francois	Lee's Summit	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri, Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain/discomfort levels reported on Visual Analogue Scales		Assessments conducted at six intervals during a 24 hour period