Effectiveness of Handheld Ultrasound for Diagnosing Patients with TMD

NCT05324826 | Completed FDA Device

• 1 other identifier: B2022:010
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Disorders; Magnetic Resonance Image; Handheld Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Butterfly Network handheld ultrasound DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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. There is no requirement for a control group, because the preliminary diagnosis obtained from the ultrasound will be compared to the MRI results on the same patient.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Manitoba: lead
• Butterfly Network: collaborator

Study Sites (1)

Dr. Adnan Shah

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Related 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.

  PMID: 32426167 BACKGROUND

• 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.

  PMID: 11474436 BACKGROUND

• 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.

  PMID: 29400370 BACKGROUND

• 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.

  PMID: 26464595 BACKGROUND

• 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.

  PMID: 30810356 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Adnan Shah, BDS, FRCDC

  University of Manitoba

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 12, 2022
• Study Start: May 16, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: March 27, 2025

Record last verified: 2024-12

Locations

CA (1)