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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-50
SponsorAlexandria University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 635 nm red diode laser

    Other intervention

    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.

  • 940 nm NIR diode laser (Biolase)

    Other intervention

    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.

  • 1064 nm Nd:YAG laser (Fotona)

    Other intervention

    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.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: PBM therapy IExperimental treatment 1 intervention
Group B: PBM therapy IIExperimental treatment 1 intervention
Group C: PBM therapy IIIExperimental treatment 1 intervention

Trial outcomes

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

Time frame
up to 12 weeks

Secondary outcomes

1

Change in maximum mouth opening

Functional maximum mouth opening (MMO) unassisted and in the pain-free opening range (PFO) by digital caliper at baseline, 7,14,21 days, and 4, 12 weeks.

Time frame
up to 12 weeks
2

Change in muscles activity

Surface electromyography (sEMG) activity during rest and maximum voluntary clenching (MVC) activity using surface electrodes

Time frame
up to 12 weeks
3

Change in Number of tender points

by palpation pressure of muscles

Time frame
up to 12 weeks
4

Change in pressure pain threshold

Pressure pain threshold (PPT) over the most tender point of the masseter and temporalis muscles by a pressure algometer (PA) to measure the degree of tenderness over the most tender points at the muscles

Time frame
up to 12 weeks

Other outcomes

Sponsors and contacts

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