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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Missouri, Kansas City
ClinicalTrials.gov Identifier:
NCT00484744
First received: June 7, 2007
Last updated: April 24, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Orthodontic Pain
 Drug: Acetaminophen
Drug: Avicel (placebo)
Drug: Ibuprofen
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: Acetaminophen Versus Ibuprofen for the Control of Immediate and Delayed Pain Following Orthodontic Separator Placement

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Missouri, Kansas City:

Primary Outcome Measures:
  • Pain/discomfort levels reported on Visual Analogue Scales [ Time Frame: Assessments conducted at six intervals during a 24 hour period ]

Enrollment: 35
Study Start Date: June 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acetaminophen Drug: Acetaminophen
Experimental: Ibuprofen Drug: Ibuprofen
Placebo Comparator: Avicel Drug: Avicel (placebo)

  Eligibility

Ages Eligible for Study:   9 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00484744

Locations
United States, Missouri
Orthodontic office of Drs. Dan Blackwell, Beth Blackwell-Nill, Scott Francois
Lee's Summit, Missouri, United States, 64063
Orthodontic office of Dr. James Osborne
Lee's Summit, Missouri, United States, 64082
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: University of Missouri, Kansas City
ClinicalTrials.gov Identifier: NCT00484744     History of Changes
Other Study ID Numbers: 07 04-054
Study First Received: June 7, 2007
Last Updated: April 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri, Kansas City:
pain
orthodontic
acetaminophen
ibuprofen
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Additional relevant MeSH terms:
Acetaminophen
Ibuprofen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013