Effectiveness of Handheld Ultrasound for Diagnosing Patients With TMD

Sponsor
University of Manitoba (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05324826
Collaborator
Butterfly Network (Industry)
50
32.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Butterfly Network handheld ultrasound

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Comparison of the Effectiveness of Handheld Ultrasound With MRI for Diagnosing Patients With Temporomandibular Joint Disorders
Anticipated Study Start Date :
Apr 15, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Outcome Measures

Primary Outcome Measures

  1. Comparison of the diagnosis obtained from handheld ultrasound to the diagnosis obtained from MRI [April 2022-December 2024]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Manitoba
  • Butterfly Network

Investigators

  • Study Director: Adnan Shah, BDS, FRCDC, University of Manitoba

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT05324826
Other Study ID Numbers:
  • B2022:010
First Posted:
Apr 12, 2022
Last Update Posted:
Apr 12, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 12, 2022