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.

March 18, 2026 updated by: Farida Elkhouli, Cairo University

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

29

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

  • Egypt
      • Cairo, Egypt
        • Cairo University

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with chronic orofacial pain
Device: The Jaw Motion Analyzer (JMA, Zebris, Germany) as the index test
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)
Diagnostic test: Research Diagnostic Criteria for Temporomandibular Disoders
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
Radiation: Magnetic Resonance Imaging
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Farida A Elkhouli, Master degree researcher, Department of prosthodontics. Cairo University
  • Study Chair: Amal M. Mahmoud, Professor of Prosthodontics, Department of prosthodontics. Cairo University
  • Study Chair: Mohamed K. Khashab, Associate Professor, Department of prosthodontics. Cairo University
  • Study Chair: Haitham S Sharshar, clinical researcher, Cairo University
  • Study Director: Iman A Radi, Professor of Prosthodontics, Department of prosthodontics. Cairo University

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

  • 1- Calil BC, Da Cunha DV, Vieira MF, De Oliveira Andrade A, Furtado DA, Bellomo Junior DP, et al. Identification of arthropathy and myopathy of the temporomandibular syndrome by biomechanical facial features. Biomed Eng Online [Internet]. 2020 Apr 15 [cited 2024 Aug 22];19(1). Available from: /pmc/articles/PMC7161015/

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 (Actual)

March 2, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

February 1, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • jawmotionanalyzerrdctmdmri2026
  • 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patients flow chart timeline , number , eligibility, subdivision variables and outcome results. In addition to data sample that emphasizes the healthy , borderline and diseased.

IPD Sharing Time Frame

end date : 1/1/2027

IPD Sharing Access Criteria

based on mail contact request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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