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NCT Number: NCT02294799

Magnetic Ressonance Imaging of Temporomandibular Joint

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nove de Julho

São Paulo, 01415000, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention group

Other

Grade 1, Nonspecific Mandibular Mobilization

Other names: Mandibular Mobilization

Placebo Group

Other

Nonspecific Mandibular Movement.

Other names: Placebo Mandibular Mobilization

Primary outcomes

  1. Articular Disc Positioning (Measured by the Magnetic Ressonance Imaging)

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

    Measured by the Magnetic Ressonance Imaging

Secondary outcomes

  1. Clinical Symptoms (Measured by END)

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

    Measured by numerical scale of pain assessment (END)

  2. Functionality (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.

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

  3. Quality of life (Whoqol-bref)

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

    Whoqol-bref

Study contacts

Contact information is provided by the study sponsor or research team.

DANIELA AP BIASOTTO-GONZALEZ, PHD

CONTACT

[email protected]

+55 11 36659325

Sponsors and collaborators

Lead sponsor

Daniela Ap. Biasotto-Gonzalez

Other

Registry information

Official study title

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

Acronym: MRITMJ

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Nov 19, 2014
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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