Title: Vascular photobiomodulation as therapy in the treatment of children and adolescent with temporomandibular disorders - Study protocol for a randomized, controlled, blind, clinical trial

Abstract

This study aims to verify if the use of intravascular laser irradiation of blood (ILIB) influences the reduction of pain and increases the range of motion in opening and closing of the mouth in children and adolescents with Temporomandibular Disorders (TMD). Methods: This will be a blind, randomized and controlled clinical trial, which will be carried out on children between 6 and 12 years of age who enter the Catholic University of Uruguay, Faculty of Health Sciences, Postgraduate School, for treatment. To be included, children must present temporomandibular disorders, based on the diagnostic criteria will be the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). Forty-five participants will be randomized to three groups: Group 1 – ILIB with 2 sessions of 20 minutes for 12 weeks (n=15); Group 2 – Placebo laser application with 2 sessions of 20 minutes for 12 weeks (n=15); Group 3 – Control with no treatment (n=15). Irradiation will be performed by continuous and direct transcutaneous application to the radial artery, by means of a bracelet that inserts the laser beam. The laser to be used is infrared, power 100 mW ±20%, wavelength 808nm ±10 nm, continuous application. RDC/TMD and pain evaluated through a visual analog scale will be the outcome measures. Discussion: Due to the low level of evidence, new studies are needed on the effect of ILIB in children with TMD.