title: Evaluation of effect of low-level laser therapy on adolescents with temporomandibular disorder: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  A number of problems involving the temporomandibular joint (TMJ) and associated structures can lead to temporomandibular disorder (TMD). The aim of the proposed study is to assess the effect of low-level laser therapy on occlusal contacts, mandibular movements, electromyography activity in the muscles of mastication and pain in adolescents with TMD.
  
  
  METHODS
  A randomized, controlled, double-blind, clinical trial will be carried out involving 85 male and female adolescents between 15 and 18 years of age. The research diagnostic criteria for TMD will be used to assess all individuals who agree to participate. All participants will be submitted to a clinical examination and electromyographic analysis of the masseter muscles and anterior bundle of the temporal muscles bilaterally, to determine TMD. Based on the clinical findings, the participants will be classified as having or not having TMD. Those with TMD will be divided into four groups, three of which will receive low-level laser therapy and one of which will receive a placebo treatment. The treatments will involve the TMJ region alone, the masseter and temporal muscles alone, or both these regions together. The data will be submitted to descriptive statistical analysis. The chi-square test and Fisher's exact test will be used to determine associations among the categorical variables. The Student's t test and analysis of variance will be used for the comparison of mean electromyographic signals. Pearson's correlation coefficients will be calculated for the analysis of correlations among the continuous variables.
  
  
  BACKGROUND
  The protocol for this study has been submitted to Clinical Trials - registration number NCT01846000.
authors.affiliation: Postgraduate Program in Rehabilitation Sciences, Universidade Nove de Julho (UNINOVE), São Paulo, SP, Brazil.
authors.forename: Camila Haddad Leal
authors.initials: CH
authors.lastname: de Godoy
authors.forename: Paula Fernanda da Costa
authors.initials: PF
authors.lastname: Silva
authors.forename: Deise Sales
authors.initials: DS
authors.lastname: de Araujo
authors.forename: Lara Jansiski
authors.initials: LJ
authors.lastname: Motta
authors.forename: Daniela Aparecida
authors.initials: DA
authors.lastname: Biasotto-Gonzalez
authors.forename: Fabiano
authors.initials: F
authors.lastname: Politti
authors.forename: Raquel Agnelli
authors.initials: RA
authors.lastname: Mesquita-Ferrari
authors.forename: Kristianne Porta Santos
authors.initials: KP
authors.lastname: Fernandes
authors.forename: Regiane
authors.initials: R
authors.lastname: Albertini
authors.forename: Sandra Kalil
authors.initials: SK
authors.lastname: Bussadori
mesh_terms: D000293:Adolescent; D000704:Analysis of Variance; D001696:Biomechanical Phenomena; D001938:Brazil; D016009:Chi-Square Distribution; D002985:Clinical Protocols; D004311:Double-Blind Method; D004576:Electromyography; D005157:Facial Pain / Q000175:diagnosis / Q000532:radiotherapy; D005260:Female; D006801:Humans; D028022:Low-Level Light Therapy; D008297:Male; D008406:Masseter Muscle / Q000503:physiopathology / Q000528:radiation effects; D008409:Mastication; D010147:Pain Measurement; D011237:Predictive Value of Tests; D012107:Research Design; D013703:Temporal Muscle / Q000503:physiopathology / Q000528:radiation effects; D013704:Temporomandibular Joint / Q000503:physiopathology / Q000528:radiation effects*; D013705:Temporomandibular Joint Disorders / Q000175:diagnosis / Q000503:physiopathology / Q000532:radiotherapy*; D013997:Time Factors; D016896:Treatment Outcome