Diagnostic Study Accuracy of Jaw Motion Analyzer(JMA) Versus Research Diagnostic Criteria(RDC/TMD) and Magnetic Resonance Imaging(MRI) for Temporomandibular Disorders Among Patients With Chronic Orofacial Pain.

N/AEnrolling By InvitationNCT07486609

Cairo University29 enrolled

Overview

The goal of this diagnostic accuracy study is to determine the diagnostic accuracy of jaw motion analyzer(JMA) in terms of sensitivity and specificity with target cut of points used by valid reference standards which will be the research diagnostic criteria(RDC/TMD) and magnetic resonance imaging(MRI) for Temporomandibular disorders(TMDs). The main questions the study aim to answer are : * Does the actual precision of JMA which will achieve the target cut off diagnostic values in diagnosing TMDs ? * How much accuracy values to be achieved by JMA compared to RDC/TMD and MRI as reference standards ? Researchers will determine the precision values of JMA for patients with chronic orofacial pain for targeting TMDs and compare with valid diagnostic reference standards which are the RDC/TMD and MRI. Participants with chronic orofacial pain will undergo through two diagnostic interventions in two separate visits with one week interval; first visit will be intraoral scan(IOS) for both upper and lower dental arches with bite registration followed with IOS import in JMA (WINJAW+3.0, Zebris GmbH Germany) to measure the trajectory of mandibular movements and condylar path tracking and accordingly both functional and EPA reports will be extracted to obtain both graph tracing records of both mandibular and condylar path trajectories. On the second visit, participants will be examined by the RDC/TMD clinical examination based algorithms to diagnose TMDs and MRI will be used as confirmative approach.

Evaluating the diagnostic accuracy of Jaw Motion Analyzer (JMA) in distinguishing temporomandibular disorders among patients with chronic orofacial pain relative to the Research Diagnostic Criteria for TMD ( RDC/TMD) and Magnetic Resonance Imaging.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Interventions

The Jaw Motion Analyzer (JMA, Zebris, Germany) as the index testDEVICE

The Research Diagnostic Criteria for TMD (RDC/TMD) constitute a diagnostic protocol that is widely employed by clinical and research personnel . The RDC/TMD employs a set of standardized clinical and questionnaire items used to administer and score the suspected patients with TMD in to two main groups ; RDC/TMD Axis I clinical diagnosis that subdivides the TMD in to three diagnostic groups that include 8 sub diagnoses and RDC/TMD Axis II assessment of TMD - related psychological disability. In addition to Magnetic Resonance Imaging(MRI) especially sagittal and coronal views reveals acceptable accuracy to detect or exclude disk displacements and presence of inflammatory articular surface changes as indicators for degenerative joint diseases.

Research Diagnostic Criteria for Temporomandibular DisodersDIAGNOSTIC_TEST

The Research Diagnostic Criteria for TMD (RDC/TMD) constitute a diagnostic protocol that employs a set of standardized clinical and questionnaire items used to administer and score the suspected patients with TMD in to two main groups ; RDC/TMD Axis I clinical diagnosis that subdivides the TMD in to three diagnostic groups that include 8 sub diagnoses and RDC/TMD Axis II assessment of TMD - related psychological disability . RDC/TMD Axis I clinical diagnosis subdivides the TMD in to three diagnostic groups that include 8 sub diagnoses to include group I ; muscle Disorders which constitutes (Ia) myofascial pain , (Ib) myofascial pain with limited opening , group II Disc Displacements which constitutes (IIa ) disc displacement with reduction , (IIb) disc displacement without reduction with limited opening and (IIc) disk displacement without reduction without limited opening and group III Arthralgia , Arthritis , Arthrosis

Magnetic Resonance ImagingRADIATION

MRI especially sagittal and coronal views reveals acceptable accuracy to detect or exclude disk displacements among intra articular derangements , changes in configuration and osseous changes of Temporomandibular joints.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with Class I skeletal and / or dental * Adult patients from 18 years of age . * Chronic orofacial pain from at least the past 30 days . Exclusion Criteria: * Patients with Class II skeletal ( vertical growth pattern ) * Patients with Class II skeletal ( Horizontal growth pattern ) * Patients with Class III cases * Patients with Deep Over bite * Patients with with any skeletal disorders such as cherubism , synovial chondromatosis , tumors * Patients with Periodontally affected teeth * Patients with pacemakers * Patients carriers of ferromagnetic metallic implants * Patients with claustrophobia from MRI * Patients with severe obesity

Outcomes

Primary Outcomes

Diagnostic accuracy of Jaw motion analyzer versus Research Diagnostic Criteria and Magnetic Resonance Imaging for Temporomandibular disorders: A pilot study

The diagnostic accuracy methods will be measured are sensitivity, specificity and over all diagnostic accuracy. Since all tests, index and reference standards, will be performed in the same series of patients then paired data will be statistically analyzed as qualitative nominal data so McNemar's and Chi-square tests will be used .For the inter examiner agreement, Cohen's Kappa test will be used for all the categorial variables.

Time frame: Patients are scheduled to undergo primarily with the index test JMA( Jaw Motion Analyzer WINJAW+3.0, Zebris GmbH Germany) followed by RDC/TMD and MRI , the reference standards, by one week interval in between the two visits.