RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain of Initial Orthodontic Wire Insertion: a Randomized Controlled Trial

Quick Facts

Study Start:2019-12-10
Study Completion:2025-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04059172

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * scheduled to begin comprehensive orthodontic treatment (banding/bonding of at least 10 teeth in 1 arch and archwire placement in at least 1 arch);
  2. * extractions, if required, performed at least 2 weeks before appliance and archwire placement;
  3. * healthy with no significant medical findings;
  4. * no prophylactic antibiotic coverage required;
  5. * currently not taking antibiotics or analgesics;
  6. * no contraindications to the use of acetaminophen or ibuprofen; and
  7. * minimum age of 12 years
  1. * Under the age of 12 or over the age of 80,
  2. * prisoners,
  3. * pregnant women,
  4. * decisionally challenged individuals,
  5. * allergy to either medication,
  6. * history of kidney disease,
  7. * liver damage or disease,
  8. * alcoholism/use of 3 or more alcoholic drinks during study period,
  9. * use of blood thinners,
  10. * stomach ulcers or
  11. * stomach bleeding.

Contacts and Locations

Study Contact

Clifton M Carey, PhD
CONTACT
3037241046
clifton.carey@cuanschutz.edu

Study Locations (Sites)

University of Colorado, School of Dental Medicine
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-10
Study Completion Date2025-03-01

Study Record Updates

Study Start Date2019-12-10
Study Completion Date2025-03-01

Terms related to this study

Additional Relevant MeSH Terms

  • Pain, Orofacial