Effects of Photobiomodulation with LED Cluster on Mandibular and Cervical Mobility, Pain and Quality of Life in Patients with Temporomandibular Dysfunction: A Clinical Study Protocol

The term temporomandibular disorders (TMD), according to the American Dental Association (ADA), refers to a group of disorders characterized by pain in the temporomandibular joint (TMD) in the preauricular area or in the muscles of chewing, in addition to the TMD sounds during mandibular function and deviation or restriction of mandibular movements. Its multifactorial etiology is related to a heterogeneous group of functional, structural, and psychological factors, making it difficult to identify the association between a single etiological factor and the signs and symptoms of TMD. It has been demonstrated in various studies that photobiomodulation (PBM) is a preferred treatment option for temporomandibular disorders. However, there is a need to establish protocols that specifically address the multifactorial aspects of this disorder. Additionally, considering the use of clusters may help optimize the treatment. The objective of this study is to evaluate the effects of photobiomodulation using clusters of 850nm LEDs (infrared) and 630nm LEDs (red) on pain, and also in cervical and mandibular mobility in patients with TMD. This randomized, controlled, and blind clinical trial will include 36 patients, randomized into 2 groups: Group 1 Red and infrared LED cluster, Group 2 control (placebo - simulation of irradiation). The irradiated areas (n=12) will include the TMJ, masseter muscles, temporal muscles, ECOM, scalenus and trapezius. Diagnostic Criteria for Temporomandibular Disorders - DC/TMD will be used to include TMD patients in the study. The primary outcome of this study will be pain evaluated using the visual analog scale (1-10cm). The secondary outcomes include cervical spine mobility using a goniometer (fleximeter) that will be used for cervical range of motion and to measure a mandibular range of motion (ADM), a pachymeter will be used. Data analysis: All outcomes will be evaluated at baseline and two weeks after treatment to allow comparisons between the 2 groups Normality will be assessed using the Shapiro-Wilk test. If the data follow a normal distribution, a two-way ANOVA will be used for analysis. Results will be expressed as means with standard deviation (± SD), and statistical significance will be set at p < 0.05.