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Completed NCT07745660

Magnesium Sulfate After TMJ Arthrocentesis

Conditions: Temporomandibular Joint Arthralgia, Temporomandibular Joint Disc Displacement

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 33
Sponsor: Yuzuncu Yil University

Location: Van Yuzuncu Yil University Faculty of Dentistry İpekyolu Van

Summary

Temporomandibular joint (TMJ) arthrocentesis is a well-established minimally invasive treatment for patients with TMJ arthralgia and internal derangement. Although intra-articular hyaluronic acid is frequently administered following arthrocentesis to improve pain relief and joint function, evidence regarding the efficacy of intra-articular magnesium sulfate remains limited. Magnesium sulfate has demonstrated analgesic and anti-inflammatory properties through N-methyl-D-aspartate (NMDA) receptor antagonism and modulation of calcium influx; however, its clinical use in TMJ disorders has not been adequately investigated. This investigator-initiated, single-center, three-arm randomized controlled pilot trial was conducted to compare the clinical effectiveness and safety of intra-articular magnesium sulfate, hyaluronic acid, and normal saline administered after TMJ arthrocentesis in patients diagnosed with TMJ arthralgia according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). The primary outcome was the change in chewing pain measured using the Visual Analog Scale (VAS) at 4 weeks. Secondary outcomes included maximum mouth opening, Jaw Functional Limitation Scale-8 (JFLS-8), Oral Health Impact Profile-14 (OHIP-14), Graded Chronic Pain Scale version 2.0 (GCPS v2.0), Patient Health Questionnaire-4 (PHQ-4), analgesic consumption, and adverse events.

Eligibility Criteria

Inclusion Criteria:Age between 18 and 65 years. Diagnosis of temporomandibular joint arthralgia and/or painful disc displacement with reduction or disc displacement without reduction with limited opening according to DC/TMD Axis I criteria. Predominantly unilateral temporomandibular joint symptoms lasting for at least 6 weeks. Resting or chewing-related pain intensity of at least 4 on a 0-10 Visual Analog Scale. Clinical indication for temporomandibular joint arthrocentesis. Ability to understand and complete the Turkish-language questionnaires. Provision of written informed consent. - Exclusion Criteria:Active local or systemic infection. Advanced degenerative temporomandibular joint disease, defined by clinical crepitus together with advanced imaging findings or Wilkes stage IV-V disease. Intra-articular injection within the previous 3 months. Temporomandibular joint arthroscopy or open joint surgery within the previous 6 months. Pregnancy or breastfeeding. Coagulopathy or use of anticoagulant medication that could not be discontinued. Known hypersensitivity to any of the study agents. Severe psychiatric disorder or any condition preventing completion of the study questionnaires. \-

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07745660). StuddyBuddy aggregates publicly available trial information.