Magnetic Ressonance Imaging of Temporomandibular Joint

Study Overview
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Brief Summary
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Background: Among the instrumental devices that have been proposed over the years to integrate the clinical evaluation of temporomandibular joint disorders (TMD), imaging techniques are the most studied, showing that magnetic resonance imaging (MRI) is the technique most need to describe the anatomy of the TMJ and to evaluate the correlation of imaging findings with the clinical diagnosis . Despite the amount available studies on the use of MRI for evaluation of TMJ disorders and treatments, there is a lack of studies that evaluate the imaging findings after physical therapy. Purpose: To evaluate the influence of nonspecific mandibular mobilization about the positioning of the articular disc by MRI in individuals with TMD diagnosis of anterior disc displacement with and without reduction according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). Analyze the behavior of pain through the numerical scale of pain assessment (END) at baseline and after each treatment session, the quality of life of individuals with TMD at baseline, immediately, three and six months after the treatment sessions by the World Health Organization Quality of Life Assessment (WHOQOL - BREF), and The Patient's Specific Functional Scale (PSFS) at baseline and after treatment. The treatment will be performed three times a week during four weeks. Metodology: This is a randomized, placebo controlled, blind study designed to assess the effects of techniques nonspecific mandibular mobilization x placebo. Individuals will be randomized and divided into two groups: Group A (intervention) and Group B (placebo). Statistic analysis: The positioning of the articular disc, extracted through the use of MRI, will be considered the primary outcome and, as a secondary outcome will be assessed the quality of life, pain and function after treatment. The adherence of the data to a Gaussian curve will be verified by the Shapiro-Wilk and the data are expressed as mean values and standard deviation. Two-way repeated measures analysis of variance with Bonferroni post hoc test will be used for inter-and intra-group comparisons. The significance level is adjusted p ≤ 0.05.

Detailed Description
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This is a randomized, placebo-controlled, double-blind study designed to verify the effects of nonspecific mandibular mobilization techniques x placebo

Official Title
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Magnetic Ressonance Imaging Evaluation of Articular Disc Position in TMD Subjects After Mandibular Mobilization. A Double Blind, Randomized, Placebo-controlled Study

Conditions
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Temporomandibular Joint Dysfunction

Intervention / Treatment
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* Other: Intervention Group
* Other: Placebo group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: TMD diagnosed subjects by RDC / TMD confirmed by the MRI findings, with anterior disk displacement with or without reduction, with full dentition (excluding third molars). Exclusion Criteria: Subjects diagnosed TMD exclusively muscular; with posterior and / or medial displacement of the disc; showing systemic diseases that affect the joints and / or masticatory muscles; neuromuscular diseases; hypo / condylar hyperplasia; making use of any type of dental prosthesis; are in orthodontic and / or physical therapy; showing neurological or behavioral disorders that preclude the achievement of MRI and/or a history of previous TMJ surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention Group<br>TMD diagnosed sujects that will receive the mobilization treatment | Other: Intervention Group<br>* Grade 1, Nonspecific Mandibular Mobilization<br>* Other names: Mandibular Mobilization;|
| Placebo Comparator: Placebo Group<br>TMD diagnosed sujects that will receive the placebo treatment | Other: Placebo group<br>* Nonspecific Mandibular Movement.<br>* Other names: Placebo Mandibular Mobilization;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Articular Disc Positioning (Measured by the Magnetic Ressonance Imaging) | Measured by the Magnetic Ressonance Imaging | Baseline (day 1) and after 4 weeks of treatment performed 3 times a week. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Symptoms (Measured by END) | Measured by numerical scale of pain assessment (END) | Baseline (day 1) and after 4 weeks of treatment performed 3 times a week. | 
| Functionality (Mesuread by The Patient´s Specific Funcional Scale - HORN, 2012) | Mesuread by The Patient´s Specific Funcional Scale - HORN, 2012 | Baseline (day 1) and after 4 weeks of treatment performed 3 times a week. | 
| Quality of life (Whoqol-bref) | Whoqol-bref | Baseline (day 1) and after 4 weeks of treatment (performed 3 times a week), 3 and 6 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Temporomandibular Joint Disorders, Magnetic Ressonance Imaging, Complementary Therapy, Physical Therapy Modalities.