Clinical trial NCT02294799: Magnetic Ressonance Imaging of Temporomandibular Joint
Official title: Magnetic Ressonance Imaging Evaluation of Articular Disc Position in TMD Subjects After Mandibular Mobilization. A Double Blind, Randomized, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Temporomandibular Joint Dysfunction
Keywords: Temporomandibular Joint Disorders
Magnetic Ressonance Imaging
Complementary Therapy
Physical Therapy Modalities.
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2014-11-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Articular Disc Positioning (Measured by the Magnetic Ressonance Imaging)
timeFrame: Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.
Secondary outcomes:
measure: Clinical Symptoms (Measured by END)
timeFrame: Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.
measure: Functionality (Mesuread by "The Patient´s Specific Funcional Scale - HORN, 2012)
timeFrame: Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.
measure: Quality of life (Whoqol-bref)
timeFrame: Baseline (day 1) and after 4 weeks of treatment (performed 3 times a week), 3 and 6 months follow up
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Nove de Julho
state: São Paulo
Study officials:
affiliation: University of Nove de Julho
name: Daniela Ap Biasotto-Gonzalez, PHD
role: PRINCIPAL_INVESTIGATOR
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