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.

Official title

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

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.

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.

Interventions

• 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 a
• 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 diagno
• 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.

Primary outcome measures

• 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Sequential

Masking

Open label

Primary purpose

Diagnostic

Study locations

Egypt · 1 center

• Cairo University — Cairo

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. PMID 32295597

Identifiers

NCT: NCT07486609 · jawmotionanalyzerrdctmdmri2026 · 1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗