Magnetic Ressonance Imaging of Temporomandibular Joint

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorDaniela Ap. Biasotto-Gonzalez

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intervention Group

    Other intervention

    Grade 1, Nonspecific Mandibular Mobilization

  • Placebo group

    Other intervention

    Nonspecific Mandibular Movement.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Intervention GroupOther 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Articular Disc Positioning (Measured by the Magnetic Ressonance Imaging)

Measured by the Magnetic Ressonance Imaging

Time frame
Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.

Secondary outcomes

1

Clinical Symptoms (Measured by END)

Measured by numerical scale of pain assessment (END)

Time frame
Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.
2

Functionality (Mesuread by "The Patient´s Specific Funcional Scale - HORN, 2012)

Mesuread by "The Patient´s Specific Funcional Scale - HORN, 2012

Time frame
Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.
3

Quality of life (Whoqol-bref)

Whoqol-bref

Time frame
Baseline (day 1) and after 4 weeks of treatment (performed 3 times a week), 3 and 6 months follow up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daniela Ap. Biasotto-Gonzalez

Lead sponsor

University of Nove de Julho

Sponsor institution

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