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临床试验/NCT02839967
NCT02839967已完成不适用

Influence of Intraoral Photobiomodulation on Pain, Joint Mobility, Functionality and Quality of Life in Individuals With Temporomandibular Joint Dysfunction

University of Nove de Julho2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年9月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Intensity of pain as measured by Visual analogue scale

研究概览

简要总结

According to the International Association for the Study of Pain (IASP), the temporomandibular pain and dysfunction syndrome (TMD) is characterized as a subset of orofacial pain, whose signs and symptoms include pain or discomfort in the temporomandibular joints. Pain is considered one of the most common and limiting clinical manifestations. One of the most used resources to treat muscle pain is the low-level laser therapy (LLLT), However, the mechanisms responsible for the effects observed in clinical trials remain poorly elucidated, as well as therapy with light emitting diode therapy (LEDT) which, has some advantages, among them the larger area radiation point and low cost. However, its effects remain elusive in intraoral application in temporal muscle, lateral and medial pterygoid muscle. Assuming that there is need to investigate therapeutic resources that combine not only different wavelengths as well as different light sources (LED and LLLT), this study aims to evaluate the effect of photobiomodulation with a combination of different light sources on pain, joint mobility, equity and quality of jaw movements after treatment in patients with TMD. It will be made a randomized, placebo-controlled and double-blind clinical trial. Individuals participate with myogenic temporomandibular disorder, being allocated into 2 groups randomly and stratified by the method of sealed envelopes. The results will be evaluated using: RDC/TMD, digital caliper, visual analog scale, and kinematics. The protocols will be used in a 6 sessions and will be evaluated in four different moments. The analyses of the data will be performed by adopting a significance level of 5%.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with disfunction temporomandibular.
  • Limitation of mandibular opening below 40 mm.
  • score of masticatory muscle pain greater than 3 cm in accordance with EVA.

排除标准

  • women who have dental failures, total or partial prosthesis.
  • systemic diseases .
  • history of trauma to the face and or ATMor the ATM dislocation history.
  • orthodontic treatment and/or medicated that affects the musculoskeletal system.

结局指标

主要结局

Intensity of pain as measured by Visual analogue scale

时间窗: five minutes

Visual analogue scale is a tool which allows easy measurement of the intensity of the pain, and consists of a straight line of 10 cm in length, the ends have a verbal description (without pain and worst pain ever felt, respectively), in which the volunteers will be directed to make a perpendicular dash between the two extremes that represents the level of pain she presented at that time.

Measured by joint mobility

时间窗: ten minutes

Will be used a digital meter to assess the breadth of mandibular movement (in mm), i.e. will be measured the opening of the mouth, sides (right and left) and protrusion.

次要结局

  • quality of life measured by questionnaire (WHOQOL-BREF)(ten minutes)
  • Functional as measured by Patient specific Functional scale(ten minutes)

研究者

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

Daniela Ap. Biasotto-Gonzalez

Doctor

University of Nove de Julho

研究点 (2)

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