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Not yet recruiting NCT07626164

Three Photobiomodulation Wavelengths (635, 940, and 1064 nm) on Chronic Myogenic Temporomandibular Disorder

No phase Interventional Temporomandibular Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 635 nm red diode laser, 940 nm NIR diode laser (Biolase), 1064 nm Nd:YAG laser (Fotona).
Who it may be relevant to
Registry conditions: Temporomandibular Disorders. Basic parameters: 20 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy of Three Photobiomodulation Wavelengths (635, 940, and 1064 nm) on Chronic Myogenic Temporomandibular Disorder A Randomized Clinical Trial

Overview

Temporomandibular disorders (TMDs) are among the most common musculoskeletal conditions associated with chronic orofacial pain and functional disability. Chronic Myogenic TMD (MTMD) is the most prevalent subtype and is characterized by persistent masticatory muscle pain driven by peripheral and central sensitization mechanisms. Photobiomodulation (PBM) represents a conservative, non-invasive therapeutic modality within the medical management of TMD; however, the wavelength-dependent clinical and muscular effects remain inadequately defined. Aim: To compare the efficacy of three PBM wavelengths (635, 940, 1,064 nm) on pain intensity, mandibular function, surface electromyographic activity (sEMG), and pressure pain threshold (PPT) in patients with chronic myogenic TMD.

Interventions

  • Other 635 nm red diode laser
    Participants will receive PBM therapy using a 635 nm red diode laser (Lasotronix), standardized at a fluence of 8 J/cm² for energy density and Irradiance of 0.50 W/cm² power density in continuous wave using PBM applicator (8mm tip) for 16 seconds, near-contact working distance.
  • Other 940 nm NIR diode laser (Biolase)
    Participants will receive PBM therapy using a 940 nm NIR diode laser (Biolase), standardized at a fluence of 8 J/cm² and Irradiance of 0.63 W/cm² power density in continuous wave using deep tissue handpiece (10mm tip) for 12.8 seconds.
  • Other 1064 nm Nd:YAG laser (Fotona)
    Participants will receive PBM therapy using a 1064 nm Nd:YAG laser (Fotona), standardized at a fluence of 8 J/cm² energy density and Irradiance 0.53 W/cm² power density, using a genova handpiece (11mm tip) stamping technique for 15.2 sec.

Primary outcome measures

  • Change in subjective Pain Intensity [Time frame: up to 12 weeks]
Secondary outcome measures (4)
  • Change in maximum mouth opening [Time frame: up to 12 weeks]
  • Change in muscles activity [Time frame: up to 12 weeks]
  • Change in Number of tender points [Time frame: up to 12 weeks]
  • Change in pressure pain threshold [Time frame: up to 12 weeks]

Eligibility criteria

Inclusion criteria

  • Patients suffering from chronic myogenic TMD based on diagnostic criteria for diagnosis of temporomandibular joint disorders (DC/TMD) criteria. (pain increases with jaw opening, chewing, or clenching).
  • Patients suffering of unilateral or bilateral chronic pain (> 3 months' duration) related to masseter and temporalis muscles(30).
  • Patients suffering of moderate-to-severe pain intensity ≥ 4 on a 0-10 VAS
  • Patients that have not responded to conservative modes of treatment during the study and up to 3 months after last intervention. (medications, physiotherapy, splints).

Exclusion criteria

  • Patients suffering from chronic systematic conditions that alter pain sensitivity; neurological diseases, pain of dental origin, pregnancy or lactation, high blood pressure, diabetes milletus, rheumatic inflammatory disease, fibromyalgia, obstructive sleep apnea, and restrictions for the use of laser (pacemakers).
  • Participants on medications that affect pain sensitivity and perception during the last 2 weeks: anticoagulants, analgesics, or antidepressants.
  • History of surgery, arthropathy (joint disorders), facial trauma, malignant tumors or fractures in the orofacial region, neuropsychological or hormonal problems
  • Treatments: orthodontics, splints, major occlusal rehabilitation, prosthodontic therapy, previous PBM, TENS therapy, or botox for TMD in the last 6 months.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University — Alexandria

Identifiers

NCT: NCT07626164 · 1320 - 04 / 2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗