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

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.

Conditions

Pain, Orofacial

Study Overview

Study Details

Study overview

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.

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

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

Condition
Pain, Orofacial
Intervention / Treatment

-

Contacts and Locations

Aurora

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

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.

For general information about clinical research, read Learn About Studies.

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.

Ages Eligible for Study

12 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Colorado, Denver,

Study Record Dates

2025-03-01