Comparing pain relief from combined ibuprofen and acetaminophen versus ibuprofen alone or placebo after orthodontic treatment
Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain of Initial Orthodontic Wire Insertion: a Randomized Controlled Trial
This study tests if taking ibuprofen with acetaminophen works better for pain relief after getting braces than taking ibuprofen alone or a placebo.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 375 (estimated) |
| Ages | 12 Years to 80 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT04059172 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a combined regimen of ibuprofen and acetaminophen in managing pain following the placement of orthodontic appliances. Participants will be randomly assigned to one of three groups: one receiving both medications, one receiving ibuprofen alone, and one receiving a placebo. The treatment will be administered at specific intervals over four days to assess pain control. The study will be conducted in a blinded manner to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals aged 12 to 80 scheduled for comprehensive orthodontic treatment.
Not a fit: Patients with allergies to the medications, significant medical conditions, or those outside the age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide improved pain management for patients undergoing orthodontic treatment.
How similar studies have performed: Previous studies have shown that combined analgesic therapies can be more effective than single agents, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * scheduled to begin comprehensive orthodontic treatment (banding/bonding of at least 10 teeth in 1 arch and archwire placement in at least 1 arch); * extractions, if required, performed at least 2 weeks before appliance and archwire placement; * healthy with no significant medical findings; * no prophylactic antibiotic coverage required; * currently not taking antibiotics or analgesics; * no contraindications to the use of acetaminophen or ibuprofen; and * minimum age of 12 years Exclusion Criteria: * Under the age of 12 or over the age of 80, * prisoners, * pregnant women, * decisionally challenged individuals, * allergy to either medication, * history of kidney disease, * liver damage or disease, * alcoholism/use of 3 or more alcoholic drinks during study period, * use of blood thinners, * stomach ulcers or * stomach bleeding.
Where this trial is running
Aurora, Colorado
- University of Colorado, School of Dental Medicine — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Clifton M Carey, PhD
- Email: clifton.carey@cuanschutz.edu
- Phone: 3037241046
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.