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临床试验/NCT03460639
NCT03460639Unknown不适用

Administration of Low-level Laser on Muscles of Mastication Following the Induction of Initial Fatigue

University of Nove de Julho2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2017年11月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
78
试验地点
2
主要终点
Change of the masseter muscle strength determined by electromyography before and after treatment

研究概览

简要总结

Orofacial pain encompasses painful conditions, such as temporomandibular disorder. Multidisciplinary health teams seek to control such musculoskeletal disorders to improve the quality and functional capacity of the muscles of mastication. The aim of the proposed study is to evaluate the effect of low-level laser therapy as a form of treatment for the prevention of initial fatigue of the muscles of mastication (masseter and anterior temporal muscles) as well as the recovery of these muscles after induced exhaustion (caused by isometric contraction) in young adults. The participants will be 78 (n obtained from calculation of the sample size with p < 0.05) healthy male and female volunteers between 18 and 34 years of age. The volunteers will be randomly allocated to a laser group (n = 26), sham group (n = 26) and control group (n = 26). All participants will be submitted to a clinical evaluation to record mandibular movements, bite force, muscle sensitivity to palpation and initial muscle fatigue. Initial fatigue will be induced by isometric contraction of the jaws. Maximum voluntary contraction will be performed to record the time until initial exhaustion of the masseter muscle (determined by electromyography). The groups will then be submitted to the interventions: 1) active laser therapy (wavelength: 780 nm; fluence: 134 J/cm2; power: 50 mW; irradiance: 1.675 W/cm2; exposure time: 80 seconds per point) on three points of the masseter and one point on the anterior temporal muscles on each side, 2) sham laser (placebo effect) or 3) no intervention (control). Maximum voluntary contraction will be performed again after the interventions to record the time until initial exhaustion of the masseter muscle (determined by electromyography). Differences in individual time until exhaustion between the pre-intervention and post-intervention evaluations will be measured to determine the effect of low-level laser therapy.

研究设计

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

盲法说明

In the sham group, the laser will be switched off and a recording of the emission sounds will be used to give the volunteer the auditory sensation of laser therapy.

入排标准

年龄范围
18 Years 至 34 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • will be included in this study young people in the age range between 18-34 years, without diagnosis of temporomandibular disorder (TMD) and with the signed free informed consent term.

排除标准

  • will be excluded from the study individuals who are in orthodontic or orthopedic treatment of the jaw, psychological and / or physiotherapy. Also excluded are those who are taking anti-inflammatory drugs and anti-inflammatory drugs and occlusal plaques.

结局指标

主要结局

Change of the masseter muscle strength determined by electromyography before and after treatment

时间窗: Before and immediately after treatment

MVC (clenching the teeth in maximum intercuspation) will be performed to record the time until initial exhaustion of the masseter muscle (determined by electromyography). The groups will then be submitted to the interventions and MVC will be performed a second time to record the time until initial exhaustion of the masseter muscle (determined by electromyography). During the procedures, the volunteers will receive verbal encouragement as well as visual feedback on the monitor to maintain MVC. Before the readings, the volunteers will undergo training of the procedure for the acquisition of the EMG signal.

次要结局

未报告次要终点

研究者

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

Greice de Brito Bitencourt

Principal investigator

University of Nove de Julho

研究点 (2)

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