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Comparison of the Efficacy of Noninvasive Treatments in Muscle Painful Temporomandibular Joint Disorders

Comparative Efficacy of Oral Magnesium, 940-nm Low-Level Laser Photobiomodulation, and Occlusal Splint in Adults with Myogenous Temporomandibular Disorders: Open-Label Three-Arm Randomized Controlled Trial with Pain (VAS) as Primary Outcome.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251007003
Enrollment
60
Registered
2025-10-07
Start date
2025-04-30
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular muscle disorders Disorders, Temporomandibular Joint

Interventions

Participants receive Magnorm 365 mg (effervescent tablet) once daily for 4 weeks. Rescue medication permitted as paracetamol 500 mg up to three times daily if needed. No other TMD-directed therapy is
continuous use for 4 weeks with standard adjustments as required. No concurrent magnesium or laser therapy permitted.
Experimental Drug,Experimental Device,Active Comparator Device
Oral Magnesium (Magnorm 365 mg effervescent tablet),Low-Level Laser Photobiomodulation (940-nm diode
Biolase Epic 10),Occlusal Stabilization Splint (reference treatment)

Sponsors

Akdeniz University, Faculty of Dentistry
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Willing to participate (consent). 2. Adults aged 18 to 60 years. 3. Systemically healthy (ASA I). 4. No TMD-directed treatment in the last 6 months. 5. Myogenous TMD (muscle pain positive) per DC/TMD (Turkish version). 6. Dentate (no missing teeth). 7. No psychiatric treatment in the last 6 months. 8. No degenerative joint disease or subluxation per DC/TMD

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to study drugs. 2. Currently using analgesics and/or drugs affecting muscle function. 3. Any adverse effect during study treatment. 4. Neurologic or psychiatric disorders that could prevent procedures or medication intake and affect the musculoskeletal system.

Design outcomes

Primary

MeasureTime frame
Pain intensity (VAS, 0 100 mm) change from baseline Change from baseline to Week 4 (Day 28) 10-cm visual analogue scale (patient-reported jaw pain; mm). Record VAS at baseline and Week 4; compute VAS (Week 4 baseline).

Secondary

MeasureTime frame
Maximum pain-free mouth opening (mm) change from baseline Change from baseline to Week 4 (Day 28) Interincisal distance (mm) measured with ruler/caliper at pain-free limit; add overbite if applicable. Compute change (Week 4 baseline).

Countries

Turkey

Contacts

Public Contactsaffet dogan

Akdeniz University

ugurdogan@akdeniz.edu.tr05073937754

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026