Temporomandibular Joint DisordersNCT05324826
Effectiveness of Handheld Ultrasound for Diagnosing Patients with TMD
An observational study of Temporomandibular Joint Disorders and Magnetic Resonance Image, run by University of Manitoba at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders, Magnetic Resonance Image, Handheld Ultrasound
- What is being tested?
- Butterfly Network handheld ultrasound
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 16 May 2022to 1 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients under the age of 18.
- Patients unable to consent for themselves.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of Handheld Ultrasound with MRI for Diagnosing Patients with Temporomandibular Joint Disorders
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.
Read the 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.
- Being tested
- Butterfly Network handheld ultrasound
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Butterfly Network handheld ultrasoundDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: April 2022-December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start16 May 2022
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Butterfly Network
- Responsible party
- Sponsor
- Investigators
- Adnan Shah, BDS, FRCDC, Study director, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324826
- Sponsor's protocol ID
- B2022:010
- Status last verified
- Dec 2024
- First submitted
- 1 Apr 2022
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 32426167Taskaya-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.
PubMed 11474436Talmaceanu 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.
PubMed 29400370Kumar 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.
PubMed 26464595Yilmaz 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.
PubMed 30810356
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Handheld Ultrasound with MRI for Diagnosing Patients with Temporomandibular Joint Disorders
- ClinicalTrials.gov ID
- NCT05324826
- Acronym / sponsor ID
- B2022:010
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Butterfly Network
- Study start
- 16 May 2022 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients under the age of 18.
- Patients unable to consent for themselves.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Butterfly Network handheld ultrasoundPatients 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. | Device | – |
Primary outcome
Comparison of the diagnosis obtained from handheld ultrasound to the diagnosis obtained from MRI
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Background: PubMed 32426167Friedman 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.
- Background: PubMed 11474436Taskaya-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.
- Background: PubMed 29400370Talmaceanu 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.
- Background: PubMed 26464595Kumar 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.
- Background: PubMed 30810356Yilmaz 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adnan Shah, BDS, FRCDC study director
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Joint Disorders and Magnetic Resonance Image, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the diagnosis obtained from handheld ultrasound to the diagnosis obtained from MRI (time frame: April 2022-December 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05324826, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.