Postgraduate Program in Rehabilitation Sciences, Universidade Nove de Julho (UNINOVE), São Paulo, SP, Brazil.
Trials. 2013 Jul 22;14:229. doi: 10.1186/1745-6215-14-229.
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/DESIGN: 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.
The protocol for this study has been submitted to Clinical Trials - registration number NCT01846000.
许多涉及颞下颌关节（TMJ）和相关结构的问题都可能导致颞下颌关节紊乱（TMD）。本研究旨在评估低水平激光疗法对青少年 TMD 患者的咬合接触、下颌运动、咀嚼肌肌电图活动和疼痛的影响。
方法/设计：将进行一项随机、对照、双盲、临床试验，涉及 85 名 15 至 18 岁的男性和女性青少年。将使用 TMD 的研究诊断标准评估所有同意参与的个体。所有参与者将接受临床检查和双侧咀嚼肌和颞肌前束的肌电图分析，以确定 TMD。根据临床发现，参与者将被分类为患有或不患有 TMD。患有 TMD 的患者将分为四组，其中三组接受低水平激光治疗，一组接受安慰剂治疗。治疗将涉及 TMJ 区域、咀嚼肌和颞肌区域或这两个区域一起。数据将进行描述性统计分析。卡方检验和 Fisher 精确检验将用于确定分类变量之间的关联。学生 t 检验和方差分析将用于比较肌电图信号的均值。Pearson 相关系数将用于分析连续变量之间的相关性。
本研究的方案已提交给临床试验 - 注册号为 NCT01846000。
