Magnetic Ressonance Imaging of Temporomandibular Joint

NCT ID: NCT02294799

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-08-31
• Study Completion Date: 2028-12-31

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

Conditions

Temporomandibular Joint Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention Group

TMD diagnosed sujects that will receive the mobilization treatment

Group Type: OTHER

Intervention Group

Intervention Type: OTHER

Grade 1, Nonspecific Mandibular Mobilization

Placebo Group

TMD diagnosed sujects that will receive the placebo treatment

Group Type: PLACEBO_COMPARATOR

Placebo group

Intervention Type: OTHER

Nonspecific Mandibular Movement.

Interventions

Intervention Group

Grade 1, Nonspecific Mandibular Mobilization

Intervention Type: OTHER

Placebo group

Nonspecific Mandibular Movement.

Intervention Type: OTHER

Other Intervention Names

Mandibular Mobilization; Placebo Mandibular Mobilization

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daniela Ap. Biasotto-Gonzalez

OTHER

Sponsor Role: lead

Responsible Party

Daniela Ap. Biasotto-Gonzalez

Phd

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Daniela Ap Biasotto-Gonzalez, PHD

Role: PRINCIPAL_INVESTIGATOR

University of Nove de Julho

Locations

University of Nove de Julho

São Paulo, São Paulo, Brazil

Countries

Brazil

Central Contacts

DANIELA AP BIASOTTO-GONZALEZ, PHD

Role: CONTACT

dani_atm@ig.com.br

+55 11 36659325

References

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Other Identifiers

YEH1984

Identifier Type: -

Identifier Source: org_study_id