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Effectiveness of Handheld Ultrasound for Diagnosing Patients with TMD

Comparison of the Effectiveness of Handheld Ultrasound with MRI for Diagnosing Patients with Temporomandibular Joint Disorders

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05324826
Enrollment
20
Registered
2022-04-12
Start date
2022-05-16
Completion date
2024-11-01
Last updated
2025-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Handheld Ultrasound, Magnetic Resonance Image, Temporomandibular Joint Disorders

Brief summary

The aim of this research is to add to the limited body of knowledge comparing the effectiveness of ultrasound (US) to MRI diagnoses in patients with TMJ disorders. More specifically, we will review the efficacy of handheld US devices, which has not yet been done to the author's knowledge.

Detailed description

Currently, patients complaining of temporomandibular joint (TMJ) pain are evaluated clinically, which includes measurements of their maximal incisal opening (MIO) lateral and protrusive excursions, recording their current pain duration and frequency, and any clicking/popping/grinding of the joints. Based on these findings, the patient is sent for an MRI if temporomandibular joint disorder is suspected. MRI is currently the gold standard of care for imaging of the joint, as it provides valuable information on the position, morphology and signal intensity of the joints and its surrounding structures. Magnetic resonance imaging (MRI) is currently the gold standard of imaging for diagnosis of internal derangement due to its ability to provide valuable information on the position, morphology and signal intensity of the joints and its surrounding structures. However, using MRI is not without its challenges, as patients with severe TMJ pain find it difficult to complete a full TMJ series and access to MRI is often restricted due to limited locations and associated waits, further prolonging time between initial consultation and diagnosis. In addition, MRI is contraindicated in patients with metallic implants, coronary and peripheral artery stents, cardiac pacemakers, prosthetic heart valves, intrauterine contraceptive devices, and claustrophobia. For these reasons, the author believes that attempting to find an alternative reliable screening tool for internal derangement is a worthwhile endeavor. For this study, handheld ultrasound would be used at the time of clinical examination to come up with a preliminary diagnosis, and this diagnosis would be compared to the MRI findings.

Interventions

DEVICEButterfly Network handheld ultrasound

Patients would be examined with a handheld US machine which would allow for dynamic imaging chairside and could easily be integrated into both hospital-based and private clinical practices. This would allow the patient to benefit from realtime imaging and a faster preliminary diagnosis with virtually no additional risks.

Sponsors

Butterfly Network
CollaboratorINDUSTRY
University of Manitoba
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* The patient population will be those patients who meet the criteria for temporomandibular joint disorders based on clinical examination and patient history, including anterior disc displacement with or without reduction, joint effusion, or degenerative joint disease.

Exclusion criteria

* Patients under the age of 18. * Patients unable to consent for themselves.

Design outcomes

Primary

MeasureTime frameDescription
Comparison of the diagnosis obtained from handheld ultrasound to the diagnosis obtained from MRIApril 2022-December 2024Diagnosis obtained from handheld ultrasound will be compared to diagnosis obtained from MRI. This would include: anterior disc displacement with reduction, anterior disc displacement without reduction, joint effusion and osteoarthritic changes

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026