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临床试验/NCT02928809
NCT02928809Unknown不适用

Effect of Low-level Laser Administered to the Masseter and Anteriortemporal Muscles Prior to the Induction of Fatigue

University of Nove de Julho2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
试验地点
2
主要终点
Change on Bite Force

研究概览

简要总结

The objective of this study is to perform an evaluation of the effect of LLLT on the prevention of fatigue in the masseter and anterior temporal muscles in young individuals with and without TMD.

详细描述

Male and female individuals aged 18 to 23 years will be evaluated. The Research Diagnostic Criteria for Temporomandibular Disorders will be applied for the determination of the presence or absence of temporomandibular disorder. Each group (with and without temporomandibular disorder) will then be randomly allocated into a control group and experimental group submitted to pre-fatigue low-level laser therapy. Before and after the induction of fatigue, all volunteers will be evaluated with regard to the range of mandibular movement, bite force, sensitivity to palpation of the muscles evaluated and muscle fatigue. Low-level laser therapy will be administered to the masseter and anterior temporal muscles prior to the induction of fatigue, which will be induced with the use of chewing gum. The data will be submitted to descriptive statistical analysis. The chi-square test and Fisher's exact test will be used to establish the associations of the categorical variables. Pearson correlation coefficients will be calculated for the analysis of the correlation of the continuous variables.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 23 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female individuals aged 18 to 23 years with a signed statement of informed consent will be included in the study.

排除标准

  • Individuals in orthodontic or orthopedic treatment for the jaws, psychological treatment or physical therapy and those who make use of muscle relaxants, anti-inflammatory agents or bite plates will be excluded from the study.

结局指标

主要结局

Change on Bite Force

时间窗: 6 minutes

A digital dynamometer will be used for the determination of bite force. The measurements will be taken in the region of the 1st molars.

次要结局

  • Change on range of mandibular movements(6 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Camila Haddad Leal de Godoy

Doctoral Student

University of Nove de Julho

研究点 (2)

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