Magnetic Ressonance Imaging of Temporomandibular Joint
- Conditions
- Temporomandibular Joint Dysfunction
- Interventions
- Other: Intervention GroupOther: Placebo group
- Registration Number
- NCT02294799
- Lead Sponsor
- Daniela Ap. Biasotto-Gonzalez
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Intervention Group TMD diagnosed sujects that will receive the mobilization treatment Placebo Group Placebo group TMD diagnosed sujects that will receive the placebo treatment
- Primary Outcome Measures
Name Time Method Articular Disc Positioning (Measured by the Magnetic Ressonance Imaging) Baseline (day 1) and after 4 weeks of treatment performed 3 times a week. Measured by the Magnetic Ressonance Imaging
- Secondary Outcome Measures
Name Time Method Clinical Symptoms (Measured by END) Baseline (day 1) and after 4 weeks of treatment performed 3 times a week. Measured by numerical scale of pain assessment (END)
Functionality (Mesuread by "The Patient´s Specific Funcional Scale - HORN, 2012) Baseline (day 1) and after 4 weeks of treatment performed 3 times a week. Mesuread by "The Patient´s Specific Funcional Scale - HORN, 2012
Quality of life (Whoqol-bref) Baseline (day 1) and after 4 weeks of treatment (performed 3 times a week), 3 and 6 months follow up Whoqol-bref
Trial Locations
- Locations (1)
University of Nove de Julho
🇧🇷Sao Paulo, São Paulo, Brazil