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

This study is currently recruiting participants.

Verified by University of Missouri, Kansas City, June 2007

First Received: June 7, 2007 Last Updated: June 20, 2007 History of Changes

Sponsor:	University of Missouri, Kansas City
Information provided by:	University of Missouri, Kansas City
ClinicalTrials.gov Identifier:	NCT00484744

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, Ibuprofen, Avicel (placebo)	Phase IV

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Acetaminophen Versus Ibuprofen for the Control of Immediate and Delayed Pain Following Orthodontic Separator Placement

Resource links provided by NLM:

Drug Information available for: Ibuprofen Cellulose sodium phosphate Acetaminophen CT 2584 Phosphocellulose

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 ]

Estimated Enrollment:	93
Study Start Date:	June 2007

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

Contacts

Contact: Shelliann A Kawamoto, DDS

816-235-2141

sak427@umkc.edu

Locations

United States, Missouri
Orthodontic office of Drs. Dan Blackwell, Beth Blackwell-Nill, Scott Francois	Recruiting
Lee's Summit, Missouri, United States, 64063
Contact: Dan Blackwell, DDS 816-524-6525
Principal Investigator: Dan Blackwell, DDS
Orthodontic office of Dr. James Osborne	Recruiting
Lee's Summit, Missouri, United States, 64082
Contact: James W Osborne, DDS 816-537-5665
Principal Investigator: James Osborne, DDS

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

Study ID Numbers:	07 04-054
Study First Received:	June 7, 2007
Last Updated:	June 20, 2007
ClinicalTrials.gov Identifier:	NCT00484744 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Missouri, Kansas City:

pain
orthodontic
acetaminophen
ibuprofen
separator

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Ibuprofen
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Acetaminophen

ClinicalTrials.gov processed this record on February 08, 2010