CLINICAL TRIAL PROTOCOL
JOURNAL ARTICLE
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Photobiomodulation with simultaneous use of red and infrared light emitting diodes in the treatment of temporomandibular disorder: study protocol for a randomized, controlled and double-blind clinical trial.

Medicine (Baltimore) 2019 Februrary
INTRODUCTION: Temporomandibular disorder (TMD) is considered the main cause of orofacial pain of non-dental origin, and a public health problem. The symptomatology is muscular and/or articular pain, restriction of the mandibular range of motion, and changes in the mandibular movement pattern. Due to its complexity there are already treatments using various forms of therapy. Photobiomodulation using light sources, such as low-level laser or light emitting diodes (LED), with different wavelengths, in a single or combined form, allows one more therapeutic resource to be explored. The objective of this study is to evaluate the effects of photobiomodulation with the simultaneous use of red and infrared LEDs, on pain, range of mandibular movements, and on the electrical activity of masticatory muscles in individuals with TMD.

METHODS: A randomized, controlled, double-blind clinical trial is proposed, which will involve 33 individuals (n = 11 per group) of both sexes, ages 18 to 45 years in 3 groups: LED group; placebo group; and control group, submitted to 6 non-consecutive sessions of photobiomodulation totaling 2 weeks of treatment. The Research Diagnostic Criteria for Temporomandibular Disorders-RDC/TMD will be used to assess and determine the participants' TMD. The pain will be assessed using the Visual Analog Scale - VAS, the mandibular range of motion will be determined with the aid of a digital caliper, and the electrical activity of the masticatory muscles will be verified by electromyography. A mixed plate of 18 red LEDs-660 nm and 18 infrared LEDs-850 nm with power of 3.5 mW per LED, 4.45 mW/cm, radiant exposure of 5.35 J/cm, will be used for photobiomodulation. The irradiated area will be 14.13 cm, and energy of 75.6 J, in the TMJ region and in the bilateral masseter and temporal muscles. Participants from all groups will be reassessed after the first therapeutic intervention, and at the end of treatment.

DISCUSSION: We expect the use of photobiomodulation with LEDs, infra and red, to reduce pain, improve temporomandibular joint function in patients with TMD, and thus improve the general conditions of the patient.

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