Evaluation of the effectiveness of infrared light-emitting diode photobiomodulation in children with sleep bruxism: Study protocol for randomized clinical trial. BACKGROUND:  Sleep bruxism is a masticatory muscle activity characterized as rhythmic (phasic) or nonrhythmic (tonic). In children and adolescents, etiological factors, such as breathing pattern and sleep quality, have recently been addressed in studies investigating sleep bruxism. New therapies for adults, such as botulinum toxin, have been investigated, but such techniques are not applicable for individuals in the growth and development phase. METHODS:  The participants will be 76 children, which will be randomly allocated to a control group, that is group 1, absence of bruxism; group 2, children with bruxism treated with infrared light-emitting diode (LED); and group 3, bruxism treated with occlusal splint. All participants will be submitted to a clinical evaluation to evaluate muscle activity and salivary biomarkers, before and after treatments. Muscle activity will be verified by electromyography of muscles mastication, masseter and temporal, and salivary biomarkers observed will be cortisol and dopamine levels. DISCUSSION:  Photobiomodulation therapy has piqued the interest of researchers, as this noninvasive method has demonstrated positive results in problems related to muscle tissues. This document describes the protocol for a proposed study to evaluate morphological and psychosocial aspects in children and adolescents with awake bruxism and their responses to photobiomodulation therapy with infrared LED. CLINICAL TRIALS:.