Acetaminophen Versus Ibuprofen for the Control of Immediate and Delayed Pain Following Orthodontic Separator Placement
Information source: University of Missouri, Kansas City
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Orthodontic Pain
Intervention: Acetaminophen, Ibuprofen, Avicel (placebo) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Missouri, Kansas City Official(s) and/or principal investigator(s):
Shelliann A Kawamoto, DDS, Principal Investigator, Affiliation: University of Missouri-Kansas City School of Dentistry Department of Orthodontics and Dentofacial Orthopedics
Karen Williams, RDH, MS, PhD, Study Chair, Affiliation: University of Missouri-Kansas City School of Dentistry
Overall contact:
Shelliann A Kawamoto, DDS, Phone: 816-235-2141, Email: sak427@umkc.edu
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.
Clinical Details
Official title: Acetaminophen Versus Ibuprofen for the Control of Immediate and Delayed Pain Following Orthodontic Separator Placement
Study design: Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Pain/discomfort levels reported on Visual Analogue Scales
Eligibility
Minimum age: 9 Years.
Maximum age: 17 Years.
Gender(s): Both.
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
Locations and Contacts
Shelliann A Kawamoto, DDS, Phone: 816-235-2141, Email: sak427@umkc.edu
Orthodontic office of Drs. Dan Blackwell, Beth Blackwell-Nill, Scott Francois, Lee's Summit, Missouri 64063, United States; Recruiting
Dan Blackwell, DDS, Phone: 816-524-6525
Dan Blackwell, DDS, Principal Investigator
Orthodontic office of Dr. James Osborne, Lee's Summit, Missouri 64082, United States; Recruiting
James W Osborne, DDS, Phone: 816-537-5665
James Osborne, DDS, Principal Investigator
Additional Information
Starting date: June 2007
Last updated: June 20, 2007
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