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Magnesium Sulfate After TMJ Arthrocentesis

NCT07745660 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-08-04

No results posted yet for this study

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.

Conditions

  • Temporomandibular Joint Arthralgia
  • Temporomandibular Joint Disc Displacement

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.

Sponsors & Collaborators

  • Yuzuncu Yil University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2026-05-28
Completion
2026-07-29

Countries

  • Turkey (Türkiye)

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07745660 on ClinicalTrials.gov