Clinical Research Directory
Browse clinical research sites, groups, and studies.
Effectiveness of Photobiomodulation for Myofascial Pain in Temporomandibular Disorders
Sponsor: Federal University of Rio Grande do Sul
Summary
This randomized clinical trial aims to evaluate the effectiveness of photobiomodulation therapy (PBM) alone or combined with therapeutic exercises compared with placebo PBM associated with exercises in patients with myofascial temporomandibular disorders (TMD). Participants will be allocated into three groups: PBM alone, PBM combined with exercises, or placebo PBM combined with exercises. The intervention consists of 12 treatment sessions. Outcomes related to pain intensity, mandibular function, and clinical measures will be assessed over time. The study seeks to investigate whether PBM provides additional benefits in pain reduction and functional improvement in individuals with myofascial TMD.
Official title: Photobiomodulation in the Management of Myofascial Pain: A Randomized and Blinded Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2026-03-10
Completion Date
2030-12
Last Updated
2026-03-10
Healthy Volunteers
No
Interventions
Photobiomodulation Therapy
Photobiomodulation therapy (PBM) will be delivered using a dual-wavelength diode laser device (810 + 980 nm) applied extraorally over standardized anatomical points corresponding to the temporomandibular joint and masticatory muscles. The intervention is performed using a non-thermal protocol, delivering 20 J per application point. Irradiation is applied bilaterally at predefined sites, including the masseter muscle, temporomandibular joint region, and temporal muscle. The procedure is performed by trained operators according to a standardized protocol to ensure consistency across sessions. This device-based intervention aims to modulate pain, improve microcirculation, and promote functional recovery in individuals with myofascial temporomandibular disorders.
Therapeutic Exercises
A standardized home-based therapeutic exercise program will be performed once daily throughout the intervention period. The protocol includes self-massage of the masseter and temporal muscles using circular fingertip movements with light to moderate pressure, cheek inflation exercises alternating sides, and controlled mandibular opening and closing movements with the tongue positioned against the palate. Written instructions and in-person guidance will be provided, along with a demonstration video to support correct execution. Participants will receive daily reminder messages, and adherence will be monitored through individual exercise logs completed throughout the study.
Sham Photobiomodulation Therapy
Sham photobiomodulation therapy will be delivered using a Gemini EVO dual-wavelength diode laser device (810 + 980 nm) positioned and operated identically to the active PBM protocol. The device will be applied extraorally over standardized anatomical points corresponding to the temporomandibular joint and masticatory muscles; however, no therapeutic energy will be emitted, ensuring a placebo condition while maintaining participant blinding. The simulated intervention will follow the same number of sessions, duration, and procedures as the active PBM protocol.