Magnetic Ressonance Imaging of Temporomandibular Joint (MRITMJ)

February 27, 2023 updated by: Daniela Ap. Biasotto-Gonzalez

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Sao Paulo, São Paulo, Brazil, 01415000
        • University of Nove de Julho

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intervention Group
TMD diagnosed sujects that will receive the mobilization treatment
Other: Intervention Group
Grade 1, Nonspecific Mandibular Mobilization
Other Names:
  • Mandibular Mobilization
Placebo Comparator: Placebo Group
TMD diagnosed sujects that will receive the placebo treatment
Other: Placebo group
Nonspecific Mandibular Movement.
Other Names:
  • Placebo Mandibular Mobilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
Time Frame: Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.
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)
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
Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.
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
Baseline (day 1) and after 4 weeks of treatment (performed 3 times a week), 3 and 6 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daniela Ap. Biasotto-Gonzalez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

December 15, 2023

Study Completion (Anticipated)

December 15, 2023

Study Registration Dates

First Submitted

April 9, 2013

First Submitted That Met QC Criteria

November 16, 2014

First Posted (Estimate)

November 19, 2014

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YEH1984

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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