Three Photobiomodulation Wavelengths (635, 940, and 1064 nm) on Chronic Myogenic Temporomandibular Disorder
Efficacy of Three Photobiomodulation Wavelengths (635, 940, and 1064 nm) on Chronic Myogenic Temporomandibular Disorder A Randomized Clinical Trial
1 other identifier
interventional
45
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedFirst Posted
Study publicly available on registry
June 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
June 4, 2026
May 1, 2026
7 months
May 28, 2026
June 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in subjective Pain Intensity
It will be assessed using both visual analog scale (VAS) at baseline, 7,14,21 days, and 4, 12 weeks
up to 12 weeks
Secondary Outcomes (4)
Change in maximum mouth opening
up to 12 weeks
Change in muscles activity
up to 12 weeks
Change in Number of tender points
up to 12 weeks
Change in pressure pain threshold
up to 12 weeks
Study Arms (3)
PBM therapy I
EXPERIMENTALPBM therapy II
EXPERIMENTALPBM therapy III
EXPERIMENTALInterventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
- SPONSOR
Study Record Dates
First Submitted
May 28, 2026
First Posted
June 4, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
June 4, 2026
Record last verified: 2026-05