Orthodontic Pain
Conditions
Keywords
pain, orthodontic, acetaminophen, ibuprofen, separator
Brief 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.
Interventions
DRUGAcetaminophen
DRUGAvicel (placebo)
DRUGIbuprofen
Sponsors
University of Missouri, Kansas City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
9 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain/discomfort levels reported on Visual Analogue Scales | Assessments conducted at six intervals during a 24 hour period |
Countries
United States
Outcome results
None listed