Effectiveness of Handheld Ultrasound for Diagnosing Patients With TMD

Temporomandibular Joint Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05324826
• Other study ID #: B2022:010
• Status: Recruiting
• Start date: May 16, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: University of Manitoba
• Contact: Meagan A Brown, DDS
• Phone: 7802715187
• Email: brownm8[@]myumanitoba.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	Dr. Adnan Shah	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Butterfly Network

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the diagnosis obtained from handheld ultrasound to the diagnosis obtained from MRI	Diagnosis 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	April 2022-December 2024