Effectiveness of Handheld Ultrasound for Diagnosing Patients with TMD

NCT ID: NCT05324826

Last Updated: 2025-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-16

Study Completion Date

2024-11-01

Brief Summary

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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

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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.

Conditions

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Temporomandibular Joint Disorders Magnetic Resonance Image Handheld Ultrasound

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Butterfly 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Butterfly Network

INDUSTRY

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adnan Shah, BDS, FRCDC

Role: STUDY_DIRECTOR

University of Manitoba

Locations

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Dr. Adnan Shah

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

References

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Friedman SN, Grushka M, Beituni HK, Rehman M, Bressler HB, Friedman L. Advanced Ultrasound Screening for Temporomandibular Joint (TMJ) Internal Derangement. Radiol Res Pract. 2020 May 4;2020:1809690. doi: 10.1155/2020/1809690. eCollection 2020.

Reference Type BACKGROUND
PMID: 32426167 (View on PubMed)

Taskaya-Yilmaz N, Ogutcen-Toller M. Magnetic resonance imaging evaluation of temporomandibular joint disc deformities in relation to type of disc displacement. J Oral Maxillofac Surg. 2001 Aug;59(8):860-5; discussion 865-6. doi: 10.1053/joms.2001.25015.

Reference Type BACKGROUND
PMID: 11474436 (View on PubMed)

Talmaceanu D, Lenghel LM, Bolog N, Popa Stanila R, Buduru S, Leucuta DC, Rotar H, Baciut M, Baciut G. High-resolution ultrasonography in assessing temporomandibular joint disc position. Med Ultrason. 2018 Feb 4;1(1):64-70. doi: 10.11152/mu-1025.

Reference Type BACKGROUND
PMID: 29400370 (View on PubMed)

Kumar R, Pallagatti S, Sheikh S, Mittal A, Gupta D, Gupta S. Correlation Between Clinical Findings of Temporomandibular Disorders and MRI Characteristics of Disc Displacement. Open Dent J. 2015 Jul 31;9:273-81. doi: 10.2174/1874210601509010273. eCollection 2015.

Reference Type BACKGROUND
PMID: 26464595 (View on PubMed)

Yilmaz D, Kamburoglu K. Comparison of the effectiveness of high resolution ultrasound with MRI in patients with temporomandibular joint disorders. Dentomaxillofac Radiol. 2019 Jul;48(5):20180349. doi: 10.1259/dmfr.20180349. Epub 2019 Feb 28.

Reference Type BACKGROUND
PMID: 30810356 (View on PubMed)

Other Identifiers

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B2022:010

Identifier Type: -

Identifier Source: org_study_id

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