Actively Recruiting

Early Phase 1
Age: 12Years - 80Years
All Genders
Healthy Volunteers
NCT04059172

Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain Management

Led by University of Colorado, Denver · Updated on 2026-05-14

375

Participants Needed

1

Research Sites

442 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain Management

Who Can Participate

Age: 12Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Scheduled to begin comprehensive orthodontic treatment with banding/bonding of at least 10 teeth in one arch and archwire placement in at least one arch
  • Extractions, if needed, completed at least 2 weeks before appliance and archwire placement
  • Healthy with no significant medical findings
  • No need for prophylactic antibiotic coverage
  • Not currently taking antibiotics or analgesics
  • No contraindications to acetaminophen or ibuprofen
  • At least 12 years old
Not Eligible

You will not qualify if you...

  • Under 12 years old or over 80 years old
  • Prisoners
  • Pregnant women
  • Decisionally challenged individuals
  • Allergy to ibuprofen or acetaminophen
  • History of kidney disease
  • Liver damage or disease
  • Alcohol use of 3 or more drinks during the study period
  • Use of blood thinners
  • Stomach ulcers
  • Stomach bleeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University of Colorado, School of Dental Medicine

Aurora, Colorado, United States, 80045

Actively Recruiting

Loading map...

Research Team

C

Clifton M Carey, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here