Meloxicam Versus Ibuprofen for Pain Control After Third Molar Exodontia in Adult Patients

November 22, 2024 updated by: Universidad Austral de Chile

Analgesic Efficacy of Meloxicam Versus Ibuprofen for Pain Control After Third Molar Extraction in Adult Patients: Randomized Clinical Trial

Third molar extraction is a common dental procedure, offently related with pain and swelling. The purpose of this study is to evaluate if Meloxicam has a better effect relieving pain after the extraction than Ibuprofen, one of the most common pain relieving drugs administered after this procedure.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Summary: Third molar extractions are one of the most common procedures in dental practice. However, pain and swelling as postoperative sequelae are inevitable. Depending on the level of pain, which can range from moderate to severe, this symptomatology can be accompanied with pharmacological treatment, thus generating a less traumatic recovery for the patient. It is currently known that non-steroidal anti-inflammatory drugs (NSAIDs) have proven to be effective for the treatment of mild and moderate postoperative pain. Due to the wide variety of NSAIDs, it is important to know how to choose the most effective option when indicating one therapeutic option over another.

Objective: To evaluate the postoperative analgesic effectiveness of meloxicam (7.5 mg) compared to ibuprofen (400 mg) in patients undergoing third molar(s) extraction.

Design: Randomized controlled clinical trial, double-masked, designed according to CONSORT guideline requirements.

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Maxillary or mandibular third molar with semi or fully erupted crown.

Exclusion Criteria:

Patients with Systemic pathologies. Presence of third molar localized infection. Completely included third molar crown. Periodontal compromise. Pregnant or breastfeeding women. Patients with hypersensitivity to NSAIDs. Patients with a history of drug abuse. Patients who had taken any drug in the previous 24 hours. Intervention (exodontia) time longer than 45 minutes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A control. Ibuprofen
Ibuprofen 400mg tablets, 1 every 8 hours for 3 days will be administered for post-surgical pain.
Drug: meloxicam 7,5mg
Comparison of analgesic efficacy of Meloxicam Vs Ibuprofen
Other Names:
  • ibuprofen 400mg
Active Comparator: Group B experimental. Meloxicam
Meloxicam 7.5mg tablets, 1 every 12 hours for 3 days will be administered for post-surgical pain.
Drug: meloxicam 7,5mg
Comparison of analgesic efficacy of Meloxicam Vs Ibuprofen
Other Names:
  • ibuprofen 400mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Meloxicam effectiveness for post-surgical pain control.
Time Frame: 3 days
A visual analogue scale ranging from 0 points (no pain) to 10 points (intolerable pain) will be used to measure post-exodontic pain, and values will be recorded on a questionnaire.
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Austral de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Estimated)

December 15, 2024

Primary Completion (Estimated)

January 15, 2025

Study Completion (Estimated)

January 20, 2025

Study Registration Dates

First Submitted

July 5, 2024

First Submitted That Met QC Criteria

November 22, 2024

First Posted (Estimated)

November 25, 2024

Study Record Updates

Last Update Posted (Estimated)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 22, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MelvsIbu

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sensation Disorders

Clinical Trials on meloxicam 7,5mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe