NCT06704113

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2024

Shorter than P25 for phase_4

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2024

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 25, 2024

Completed
20 days until next milestone

Study Start

First participant enrolled

December 15, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2025

Completed
Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

1 month

First QC Date

July 5, 2024

Last Update Submit

November 22, 2024

Conditions

Dental PainSensation Disorders

Keywords

Tooth ExtractionMolar, ThirdMeloxicamIbuprofen

Outcome Measures

Primary Outcomes (1)

  • Meloxicam effectiveness for post-surgical pain control.

    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

Study Arms (2)

Group A control. Ibuprofen

ACTIVE COMPARATOR

Ibuprofen 400mg tablets, 1 every 8 hours for 3 days will be administered for post-surgical pain.

Drug: meloxicam 7,5mg

Group B experimental. Meloxicam

ACTIVE COMPARATOR

Meloxicam 7.5mg tablets, 1 every 12 hours for 3 days will be administered for post-surgical pain.

Drug: meloxicam 7,5mg

Interventions

meloxicam 7,5mgDRUG

Comparison of analgesic efficacy of Meloxicam Vs Ibuprofen

Also known as: ibuprofen 400mg
Group A control. IbuprofenGroup B experimental. Meloxicam

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Haffar A, Fillingham YA, Breckenridge L, Gursay D, Lonner JH. Meloxicam versus Celecoxib for Postoperative Analgesia after Total Knee Arthroplasty: Safety, Efficacy and Cost. J Am Acad Orthop Surg Glob Res Rev. 2022 Apr 5;6(4):e22.00032. doi: 10.5435/JAAOSGlobal-D-22-00032.

    PMID: 35389917BACKGROUND

  • Iqbal AM, Shetty P. Effect of Submucosal Injection of Tramadol on Postoperative Pain After Third Molar Surgery. J Oral Maxillofac Surg. 2019 Sep;77(9):1752-1759. doi: 10.1016/j.joms.2019.03.029. Epub 2019 Mar 29.

    PMID: 31026419BACKGROUND

  • Moore RA, Derry S, Aldington D, Wiffen PJ. Single dose oral analgesics for acute postoperative pain in adults - an overview of Cochrane reviews. Cochrane Database Syst Rev. 2015 Sep 28;2015(9):CD008659. doi: 10.1002/14651858.CD008659.pub3.

    PMID: 26414123BACKGROUND

  • Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother. 2010 Jul;1(2):100-7. doi: 10.4103/0976-500X.72352. No abstract available.

    PMID: 21350618BACKGROUND

  • Vallecillo C, Vallecillo-Rivas M, Galvez R, Vallecillo-Capilla M, Olmedo-Gaya MV. ANALGESIC EFFICACY OF TRAMADOL/DEXKETOPROFEN VS IBUPROFEN AFTER IMPACTED LOWER THIRD MOLAR EXTRACTION: A RANDOMIZED CONTROLLED CLINICAL TRIAL. J Evid Based Dent Pract. 2021 Dec;21(4):101618. doi: 10.1016/j.jebdp.2021.101618. Epub 2021 Jul 28.

    PMID: 34922724BACKGROUND

MeSH Terms

Conditions

ToothacheSensation Disorders

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesFacial PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNervous System Diseases

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Central Study Contacts

Carla C Bertran, DDS

CONTACT

56632228028carlabertran@yahoo.com

Ruth R Falcón

CONTACT

56 940376396ruth.falcon@alumnos.uach.cl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2024

First Posted

November 25, 2024

Study Start

December 15, 2024

Primary Completion

January 15, 2025

Study Completion

January 20, 2025

Last Updated

November 25, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share