Magnesium Sulfate After TMJ Arthrocentesis

NCT07745660 | Completed

• 1 other identifier: YYU-TMJ-2026-001
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Temporomandibular joint; Arthrocentesis; Magnesium sulfate

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Temporomandibular Joint Pain During Chewing at Week 4

  Temporomandibular joint pain during chewing was assessed using an 11-point Visual Analog Scale ranging from 0 (no pain) to 10 (worst imaginable pain). Change was calculated by comparing the Week 4 score with the baseline score. A greater reduction indicates greater improvement.

  Baseline and Week 4 (±5 days)

Secondary Outcomes (7)

• Change From Baseline in Resting Temporomandibular Joint Pain Intensity

  Baseline, Week 1 (Day 7 ±2 days), Week 4 (±5 days), and Week 12 (±10 days)

• Change From Baseline in Temporomandibular Joint Pain During Chewing at Week 1 and Week 12

  Baseline, Week 1 (Day 7 ±2 days), and Week 12 (±10 days)

• Change From Baseline in Jaw Functional Limitation Scale-8 Score

  Baseline, Week 1, Week 4, and Week 12

• Change From Baseline in Oral Health Impact Profile-14 Score

  Baseline, Week 4, and Week 12

• Change From Baseline in Maximum Mouth Opening

  Baseline, Week 1, Week 4, and Week 12

Study Arms (3)

Magnesium Sulfate Group

EXPERIMENTAL

Participants underwent temporomandibular joint arthrocentesis followed by intra-articular administration of magnesium sulfate.

Drug: Magnesium Sulfate Group → Experimental

Hyaluronic Acid Group

ACTIVE COMPARATOR

Participants underwent temporomandibular joint arthrocentesis followed by intra-articular administration of hyaluronic acid.

Drug: Hyaluronic Acid (HA)

Normal Saline Group

PLACEBO COMPARATOR

Participants underwent temporomandibular joint arthrocentesis followed by intra-articular administration of normal saline.

Drug: Normal Saline (0.9% Sodium Chloride)

Interventions

Magnesium Sulfate Group → Experimental DRUG

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.

Magnesium Sulfate Group

Hyaluronic Acid (HA) DRUG

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.

Also known as: Ostenil

Hyaluronic Acid Group

Normal Saline (0.9% Sodium Chloride) DRUG

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.

Also known as: Normal Saline

Normal Saline Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yuzuncu Yil University Faculty of Dentistry

İpekyolu, Van, 65100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Hyaluronic Acid; Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Ceren Dayanan

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start: February 1, 2026
• Primary Completion: May 28, 2026
• Study Completion: July 29, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)