Enrolling by Invitation

NCT Number: NCT07486609

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.

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.

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Key information

Conditions

Temporomandibular Disorders (TMDs) Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

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

Device

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.

Other names: Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD), Magnetic Resonance Imaging(MRI)

Research Diagnostic Criteria for Temporomandibular Disoders

Diagnostic 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 imaging

Radiation

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.

Primary outcomes

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

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.

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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Diagnostic Accuracy of Jaw Motion Analyzer Versus Research Diagnostic Criteria and Magnetic Resonance Imaging for Temporomandibular Disorders: A Pilot Study

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Mar 20, 2026
Registry last updated: Mar 20, 2026

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

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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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