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COMPLETED
NCT07745660
NA

Magnesium Sulfate After TMJ Arthrocentesis

Sponsor: Yuzuncu Yil University

View on ClinicalTrials.gov

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.

Official title: Efficacy of Intra-Articular Magnesium Sulfate Compared With Hyaluronic Acid and Saline Following Temporomandibular Joint Arthrocentesis: A Three-Arm Pilot Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2026-02-01

Completion Date

2026-07-29

Last Updated

2026-08-04

Healthy Volunteers

Yes

Interventions

DRUG

Magnesium Sulfate Group → Experimental

After completion of standardized single-needle temporomandibular joint arthrocentesis using 100-150 mL of normal saline, a single 1 mL intra-articular injection containing 100 mg of magnesium sulfate was administered into the upper joint compartment. The solution was prepared by diluting 0.67 mL of 15% magnesium sulfate with 0.33 mL of 0.9% sodium chloride.

DRUG

Hyaluronic Acid (HA)

After completion of standardized single-needle temporomandibular joint arthrocentesis using 100-150 mL of normal saline, participants received a single intra-articular injection of 20 mg hyaluronic acid in a total volume of 1 mL into the upper joint compartment.

DRUG

Normal Saline (0.9% Sodium Chloride)

After completion of standardized single-needle temporomandibular joint arthrocentesis using 100-150 mL of normal saline, participants received a single 1 mL intra-articular injection of 0.9% sodium chloride into the upper joint compartment.

Locations (1)

Van Yuzuncu Yil University Faculty of Dentistry

İpekyolu, Van, Turkey (Türkiye)