Clinical trial NCT06704113: Meloxicam Versus Ibuprofen for Pain Control After Third Molar Exodontia in Adult Patients
Official title: Analgesic Efficacy of Meloxicam Versus Ibuprofen for Pain Control After Third Molar Extraction in Adult Patients: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Dental Pain
Sensation Disorders
Keywords: Tooth Extraction
Molar, Third
Meloxicam
Ibuprofen
Lead sponsor: Universidad Austral de Chile
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Meloxicam effectiveness for post-surgical pain control.
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.