NCT04059172 Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain Management
| NCT ID | NCT04059172 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Colorado, Denver |
| Condition | Pain, Orofacial |
| Study Type | INTERVENTIONAL |
| Enrollment | 375 participants |
| Start Date | 2019-12-10 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 375 participants in total. It began in 2019-12-10 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to compare the effectiveness of a combined ibuprofen and acetaminophen regimen in controlling discomfort for 4 days after initial orthodontic appliance placement as compared to ibuprofen alone or a placebo. The hypothesis is that combined ibuprofen and acetaminophen therapy will effectively provide better pain control than ibuprofen alone or a placebo after orthodontic appliance placement.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04059172 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 80 Years, studying Pain, Orofacial. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04059172 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04059172 currently recruiting?
Yes, NCT04059172 is actively recruiting participants. Contact the research team at clifton.carey@cuanschutz.edu for enrollment information.
Where is the NCT04059172 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT04059172 clinical trial?
NCT04059172 is sponsored by University of Colorado, Denver. The trial plans to enroll 375 participants.