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Ibuprofen Versus Ibuprofen/Acetaminophen Postoperatively in Patients Needing Root Canal Therapy

NCT03631433 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2021-05-04

Study results available
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Summary

Aim: The purpose of this study was to compare ibuprofen versus an ibuprofen/acetaminophen combination for postoperative pain control in patients requiring root canal treatment with a tooth that is painful to cold and biting.

Methodology: Following regular root canal treatment, patients randomly received identical appearing tablets of 600 mg ibuprofen or 600 mg ibuprofen/650 mg acetaminophen to be taken every 6 hours as needed for pain. A 4-day diary was used to record pain and medication use.

Conditions

  • Pain, Postoperative

Interventions

DRUG

Ibuprofen 600 mg

identical appearing tablets containing 600 mg of ibuprofen

DRUG

ibuprofen 600 mg and acetaminophen 650 mg

identical appearing tablets of the combination of ibuprofen and acetaminophen

Sponsors & Collaborators

  • Ohio State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-10
Primary Completion
2017-05-01
Completion
2017-07-17
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03631433 on ClinicalTrials.gov