MRITMJ: Magnetic Ressonance Imaging of Temporomandibular Joint

Sponsor

Daniela Ap. Biasotto-Gonzalez (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT02294799

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Temporomandibular Joint Dysfunction	Other: Intervention Group Other: Placebo group	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.