BridgeMD
Compares treatment options for Pain, Orofacial
Official title Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain Management
ClinicalTrials.gov ID: NCT04059172
What this study is testing
What is Ibuprofen 200 mg and acetaminphen 650 mg?
Ibuprofen 200 mg and acetaminphen 650 mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for pain, orofacial.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 80. Healthy volunteers may be eligible.
You may be able to join if
- 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;
You likely can't join if
- 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,
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.