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.
Diagnostic Accuracy of Jaw Motion Analyzer Versus Research Diagnostic Criteria and Magnetic Resonance Imaging for Temporomandibular Disorders: A Pilot Study
2 other identifiers
interventional
29
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 2, 2025
CompletedFirst Submitted
Initial submission to the registry
February 1, 2026
CompletedFirst Posted
Study publicly available on registry
March 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
March 20, 2026
March 1, 2026
1.8 years
February 1, 2026
March 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
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.
Study Arms (1)
Patients with chronic orofacial pain
EXPERIMENTALInterventions
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.
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.
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
Eligibility Criteria
You may qualify if:
- 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 .
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Cairo, Egypt
Related Publications (1)
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/
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
February 1, 2026
First Posted
March 20, 2026
Study Start
March 2, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
March 20, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- end date : 1/1/2027
- Access Criteria
- based on mail contact request
Patients flow chart timeline , number , eligibility, subdivision variables and outcome results. In addition to data sample that emphasizes the healthy , borderline and diseased.