Magnesium Sulfate After TMJ Arthrocentesis (NCT07745660) | Clinical Trial Compass
CompletedNot Applicable
Magnesium Sulfate After TMJ Arthrocentesis
Turkey (Türkiye)33 participantsStarted 2026-02-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Temporomandibular Joint Pain During Chewing at Week 4