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

August 19, 2020 updated by: University of Missouri, Kansas City
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Lee's Summit, Missouri, United States, 64063
        • Orthodontic office of Drs. Dan Blackwell, Beth Blackwell-Nill, Scott Francois
      • Lee's Summit, Missouri, United States, 64082
        • Orthodontic office of Dr. James Osborne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ibuprofen
Drug: Ibuprofen
Experimental: Acetaminophen
Drug: Acetaminophen
Placebo Comparator: Avicel
Drug: Avicel (placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain/discomfort levels reported on Visual Analogue Scales
Time Frame: Assessments conducted at six intervals during a 24 hour period
Assessments conducted at six intervals during a 24 hour period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri, Kansas City

Investigators

  • Principal Investigator: Shelliann A Kawamoto, DDS, University of Missouri-Kansas City School of Dentistry Department of Orthodontics and Dentofacial Orthopedics
  • Study Chair: Karen Williams, RDH, MS, PhD, University of Missouri-Kansas City School of Dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

June 7, 2007

First Submitted That Met QC Criteria

June 7, 2007

First Posted (Estimate)

June 11, 2007

Study Record Updates

Last Update Posted (Actual)

August 20, 2020

Last Update Submitted That Met QC Criteria

August 19, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07 04-054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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