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临床试验/NCT02880774
NCT02880774已完成不适用

Influence of Manual Therapy in Temporomandibular Joint on the Mandibular Movement: Clinical Trial, Randomised, Placebo-controlled and Blind

University of Nove de Julho2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Mandibular Movement

研究概览

简要总结

Introduction: Temporomandibular joint dysfunction (TMD) is characterized for being a complex and multifactorial pathology, where functional and pathological changes commit temporomandibuar articulation, masticatory muscles, and other associated structures. In the light of the whole complexity of the DTM noted the necessity of interdisciplinary treatment, including physical therapy with the use of manual features, has been excelling. Objective: The aim of this study is to evaluate the influence of mandibular nonspecific mobilization on the mandibular movement and lateralidades, through the three-dimensional kinematics in subjects with diagnosis of TMD, as well as analyze the behavior of pain, quality of life and functionality of individuals with DTM pre, immediately after and 30 days of 12 treatment sessions. Method: This is a clinical trial randomised, placebo-controlled and blind, designed to study the effects of Mandibular Nonspecific Mobilization x Placebo (detuned ultrasound). Individuals will be randomised controlled trials and allocated into two groups: Group A (intervention) and Group B (placebo) and evaluated by the Research Diagnostic Criteria for Temporomandibular joint Disorders (RDC/TMD) for diagnosis of TMD, numeric scale of Pain (END), quality of life questionnaire (WHOQOL-BREF), Patient specific Functional Scale and Kinematic Analysis Tridiemsnional. Statistical Analysis: Mandibular movement will be the primary outcome and will be quantified by three-dimensional kinematic analysis. The pain, Functionality and quality of life will be the secondary outcomes. Initially the distribution of data will be checked by the Shapiro-Wilk test. In comparisons between the groups, if the data present normal distribution will be used a repeated measures ANOVA to two factors, being these: Group (intervention and placebo) and treatment (pre and post-intervention), with Bonferrone correction. If the data do not show normal distribution, a logarithmic function is used to correct striping. As level of significance will be used p < 0.05.

详细描述

Contextualization:Temporomandibular joint dysfunction (TMD) is defined as a group of heterogeneous changes affect a temporomandibular joint (TMJ), affecting anatomical and functional elements, is characterized as a complex and multifactorial disease. The most common signs are joint noises and limitations on the extent of the mandibular movements, associated or not to the articular disc displacement during a mandibular function and predominant symptoms are pain pre-Auricular, on ATM and/or masticatory muscles. A study of an urban brazilian population shows that 39.2% of evaluated feature at least one sign or symptom of TMD.

Its development can be related to the traumatic acometimentos of the jaw or occlusal interference or TMJ, malocclusion, changes in masticatory muscles, microtrauma caused by parafunctional habits, rheumatic diseases, emotional stress, anxiety and postural abnormalities, thus creating a major impact on quality of life and sleep of patients with this disease.

When there is a breakdown between anatomical condyle and articular eminence, disk, drift to occur for the most part, are characterized as previous joint disc displacement, with or without reduction. In both cases, the disk is presented prior to the mandibular condyle with mouth closed, and can resume his position, featuring a disc displacement with reduction (DDCR), having as main feature the snap during an opening. The disc may get introduced before the condyle during the entire opening movement, made a previous offset oral disc without reduction (DDSR), characterized by the presence of clicks, including, in the most serious cases, cause a limitation of motion and functional changes of the mandible, the adaptation of the retrodiscais tissue.

In the light of the whole complexity of the DTM it is necessary the involvement of a multidisciplinary team, including physiotherapy, with the use of manual features, have been highlighting. Manual therapy has been shown to be an important method for pain reduction, disabled and local ischemia, promoting the breakup of fibrous adhesions, improving extensibility of contractile structures, increasing range of motion. Notes that the use of Manual therapy favours the transmission of afferent information for the mecanoceptores stimulating a proprioception and a production of synovial fluid. Studies that have applied manual therapy, electing as mandibular mobilization technique in subjects with TMD, pain reduction and improvement of mandibular range. FELÍCIO et al. (2008), observed increase in WMD and pain reduction in patients treated with Orofacial Miofuncional Therapy in association with techniques such as massage therapy and a joint mobilization.

Knowledge of the movement of the jaw is important for a better understanding of the normal function of the temporomandibular joint (TMJ) and for the study of etiology, diagnosis and subsequent treatment of temporomandibular disorders. The mandibular movement also exerts influence on the joint development of the masticatory system. Therefore, knowing the three-dimensional movement of the jaw (3D) in relation to jaw is essential for clinical applications. A literature provides information on a range of motion measured by the distance between incisal edges of teeth like upper and lower incisors through digital central pachymetry and the average value of opening mouth of UM adult is approximately 50 mm. In patients with TMD buccal opening average is 32 mm and 44 mm to maximum opening without pain. In this way, pick up tools can exploit better a movement evaluation, will contribute without therapeutic success. The kinematics has been increasingly diffused in different areas of knowledge, as in gait analysis of adolescents, children, biomechanical related changes of the feet and Musculoskeletal changes related to patellofemoral syndrome, being useful also in the qualitative evaluation of the ATM graduates movements.

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 (Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Will be included in the study, women with TMD, diagnosed by the RDC/TMD, with diversion and/or mandibular dentition full deflection (except third molars)

排除标准

  • Not participate of the study subjects without TMD, TMD sufferers who have systemic diseases that affect the joints and/or masticatory muscles
  • Over bite (bite deep) greater than 3 mm, tooth failures, neuromuscular diseases
  • With hypo/condylar hyperplasia
  • Making use of any type of dental prosthesis; in orthodontic treatment and/or physiotherapy
  • Neurological or behavioural disorders that present that prevent the realization of kinematic analysis and/or with a history of prior surgery or orthognathic ATM.

结局指标

主要结局

Mandibular Movement

时间窗: 45 minutes

Mandiblulares movements will be quantified by 3D kinematics using the Vicon system ®. Markers, will be willing us participants at strategic points. The collections will be carried out before treatment, post 12 treatment sessions and follow up to a month. Static test: the volunteer will remain motionless, with his mouth shut, for 5 seconds while maintaining contact between the arches. Then a pointer is positioned in the right mandibular first Premolar and the individual in isometry is done collecting, this form will be collected the left side, upper left and right and between the upper and lower central incisors. Dynamics: will be held 6 repetitions in opening and closing freestyle to touch your teeth and will be carried out six straight tours and six excursions lefts of the mandible (laterality).

次要结局

  • WHOQOL-BREF for the evaluation of quality of life(15 minutes)
  • Functional range Specifies the Patient to evaluate the functionality.(5 minutes)
  • END to evaluate pain intensity(5 minutes)

研究者

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

Daniela Ap. Biasotto-Gonzalez

Daniela Aparecida Biasotto-Gonzalez

University of Nove de Julho

研究点 (2)

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