Acetaminophen Versus Ibuprofen for the Control of Immediate and Delayed Pain Following Orthodontic Separator Placement

NCT00484744 | Completed Phase 4

• 1 other identifier: 07 04-054
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this research study is to compare pain control effectiveness of two medicines and a placebo (a dummy pill that does not contain any pain relieving medication) to see which one works better at preventing pain when taken both 1 hour before and 6 hours after orthodontic separators are placed. The research hypothesis is that there will be a significant difference in pain as measured by Visual Analogue Scales (VAS) over time and that this effect will differ for acetaminophen versus ibuprofen.

Conditions

Orthodontic Pain

Keywords

pain; orthodontic; acetaminophen; ibuprofen; separator

Outcome Measures

Primary Outcomes (1)

• Pain/discomfort levels reported on Visual Analogue Scales

  Assessments conducted at six intervals during a 24 hour period

Study Arms (3)

Acetaminophen

EXPERIMENTAL

Drug: Acetaminophen

Ibuprofen

EXPERIMENTAL

Drug: Ibuprofen

Avicel

PLACEBO COMPARATOR

Drug: Avicel (placebo)

Interventions

Acetaminophen DRUG

Acetaminophen

Avicel (placebo) DRUG

Avicel

Ibuprofen DRUG

Ibuprofen

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Orthodontic treatment requires banding of posterior teeth
• Orthodontic treatment requires the placement of two or more separators
• Able to swallow analgesic pills
• English speaking
• Age 9-17
• Minimum weight requirement of 88 pounds

You may not qualify if:

• Orthodontic appliances are present in the mouth
• Use of acetaminophen or ibuprofen is contraindicated (allergy, GI problems)
• Antibiotics or analgesics are currently in use
• History of systemic disease exists (arthritis, diabetes, cystic fibrosis)
• Significant cognitive impairment

Sponsors & Collaborators

• University of Missouri, Kansas City: lead

Study Sites (2)

Orthodontic office of Drs. Dan Blackwell, Beth Blackwell-Nill, Scott Francois

Lee's Summit, Missouri, 64063, United States

Location

Orthodontic office of Dr. James Osborne

Lee's Summit, Missouri, 64082, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen; Cellulose; Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Shelliann A Kawamoto, DDS

  University of Missouri-Kansas City School of Dentistry Department of Orthodontics and Dentofacial Orthopedics

  PRINCIPAL INVESTIGATOR

• Karen Williams, RDH, MS, PhD

  University of Missouri-Kansas City School of Dentistry

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2007
• First Posted: June 11, 2007
• Study Start: June 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: August 20, 2020

Record last verified: 2020-08

Locations

US (2)