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...

Date First Received: June 7, 2007

Last Updated: June 20, 2007

Verified by: University of Missouri, Kansas City, June 2007

Clinical Trial Phase: Phase 4 | Start Date: June 2007

Overall Status: Recruiting

Estimated Enrollment: 93

Brief Summary

Official Title: “Acetaminophen Versus Ibuprofen for the Control of Immediate and Delayed Pain Following Orthodontic Separator Placement”

Condition Keyword(s):

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.

Study Type: Interventional

Study Design: Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Outcome Measures for this Clinical Trial

Primary:

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

Criteria for Participation in this Clinical Trial

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

Clinical Trials Locations, Contact Details, and Sponsors

Lead Sponsor: University of Missouri, Kansas City

Orthodontic office of Drs. Dan Blackwell, Beth Blackwell-Nill, Scott Francois

Lee's Summit Missouri 64063 United States

Orthodontic office of Dr. James Osborne

Lee's Summit Missouri 64082 United States

Overall Clinical Trial Officials and Contacts

Shelliann A Kawamoto, DDS Principal Investigator University of Missouri-Kansas City School of Dentistry Department of Orthodontics and Dentofacial Orthopedics  

Overall Contact: Shelliann A Kawamoto, DDS 816-235-2141 sak427@umkc.edu

Additional Information

Information obtained from ClinicalTrials.gov on July 23, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00484744

Study ID Number: 07 04-054

ClinicalTrials.gov Identifier: NCT00484744

Health Authority: United States: Institutional Review Board

Clinical Trials Authorship and Review

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.