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Temporomandibular Disorders (TMDs)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.

A study testing The Jaw Motion Analyzer (JMA, Zebris, Germany) as the index test, Research Diagnostic Criteria for Temporomandibular Disoders and Magnetic Resonance Imaging in people with Temporomandibular Disorders (TMDs), run by Cairo University at 1 site in Egypt.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Temporomandibular Disorders (TMDs)
What is being tested?
The Jaw Motion Analyzer (JMA, Zebris, Germany) as the index test, Research Diagnostic Criteria for Temporomandibular Disoders and Magnetic Resonance Imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteEgypt
Study dates
2 Mar 2025to 1 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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 .

Who cannot join

  • 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
Show all 10Show fewer
  • Patients with pacemakers
  • Patients carriers of ferromagnetic metallic implants
  • Patients with claustrophobia from MRI
  • Patients with severe obesity

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site

  • Cairo University

    Cairo

Other trials in Egypt

About this study

Official title: 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 :

Read more
  • 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.

Read the 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.

Being tested
The Jaw Motion Analyzer (JMA, Zebris, Germany) as the index test, Research Diagnostic Criteria for Temporomandibular Disoders, Magnetic Resonance Imaging
Keywords
Temporomandibular disorders, Chronic orofacial pain, RDC/TMD, Magnetic Resonance Imaging, Jaw Motion Analyzer
Medical subject headings
Temporomandibular Joint Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD), Magnetic Resonance Imaging(MRI)

    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.

Study groups in NCT07486609
Study groupRoleWhat they receive
Patients with chronic orofacial painExperimentalNot described
Receives: Device: The Jaw Motion Analyzer (JMA, Zebris, Germany) as the index test; Diagnostic Test: Research Diagnostic Criteria for Temporomandibular Disoders; Radiation: Magnetic Resonance Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2026
  2. Study start2 Mar 2025
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
29 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07486609
Sponsor's protocol ID
jawmotionanalyzerrdctmdmri2026
Other IDs
1
Status last verified
Mar 2026
First submitted
1 Feb 2026
Last updated
20 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Patients flow chart timeline , number , eligibility, subdivision variables and outcome results. In addition to data sample that emphasizes the healthy , borderline and diseased.

Publications

  • Calil BC, da Cunha DV, Vieira MF, de Oliveira Andrade A, Furtado DA, Bellomo Junior DP, Pereira AA. Identification of arthropathy and myopathy of the temporomandibular syndrome by biomechanical facial features. Biomed Eng Online. 2020 Apr 15;19(1):22. doi: 10.1186/s12938-020-00764-5.

    PubMed 32295597

Questions about this trial

What is this clinical trial studying?

A study testing The Jaw Motion Analyzer (JMA, Zebris, Germany) as the index test, Research Diagnostic Criteria for Temporomandibular Disoders and Magnetic Resonance Imaging in people with Temporomandibular Disorders (TMDs), run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07486609, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.

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