TMJ Internal DerangementNCT06713356
US Vs MRI in Diagnosis of TMJ Internal Derangement
An observational study of TMJ Internal Derangement, run by Assiut University.
Trial summary
Compare the accuracy of ultrasonography and magnetic resonance imaging in the diagnosis of temporomandibular joint internal derangements. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- TMJ Internal Derangement
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients showing signs of TMJ internal derangements
Who may be able to join
- Patients showing signs of TMJ internal derangements
Who cannot join
- contraindications for MRI such as claustrophobia, heart pacemaker and metallic foreign body carriers.
- patients in which the misaligned images or distortions due to motion artifacts made the interpretation of the MRI unreliable.
- Previously operated TMJ.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ultrasonographic Assessment in Comparison to MRI in Diagnosis of TMJ Internal Derangement
Compare the accuracy of ultrasonography and magnetic resonance imaging in the diagnosis of temporomandibular joint internal derangements.
Read the detailed description
Temporomandibular disorders (TMDs) are conditions that affect the temporomandibular joint (TMJ), often leading to pain and dysfunction. The most common cause of TMJ problems is internal derangements.
The term "internal derangements" refers to conditions with the articular disc displaced from its original position on the mandibular condyle.
Disc displacement may occur anteriorly, anterolaterally, laterally, anteromedially, medially, or posteriorly, but the latter is very rare.
Anterior disc displacement (ADD) is the most common ID condition and is usually divided into two categories: with reduction and without reduction. Each category has special features during closed and opened mouth positions. Therefore, the examination should include both positions.
Clinical examination alone isn't enough to diagnose TMJ problems, therefore additional imaging tests are often needed.
Magnetic resonance imaging (MRI) is the gold standard modality, however because of its limited availability, long scan time, and high cost, it is difficult to use MRI as a screening technique.
Ultrasound (US) has been recommended as an alternate diagnostic imaging modality for TMJ problems as it is less costly, non-invasive and capable of providing real-time imaging, presents an alternative diagnostic tool. Thus, the articular disc may be seen as the patient is opening and closing their mouth
- Conditions
- TMJ Internal Derangement
- Keywords
- MRI, US, TMJ, internal derangement
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between US and MRI in diagnosis of TMJ disc displacement.
Compare the accuracy of assessment of disc positioning by ultrasonography and magnetic resonance imaging in patients with TMJ disorders
.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study startDec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for TMJ Internal DerangementStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norhan Anwar Kamal El Dein Hussien, Assiut University
- Investigators
- Sami A. Sayed, Study director, Professor doctorOmran K. Qenawy, Study director, Assistant professor doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713356
- Sponsor's protocol ID
- TMJ internal derangement
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Emshoff R, Kriwanek S, Koller M, et al. Diagnostic accuracy of ultrasound in the assessment of the temporomandibular joint: a comparison with MRI. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontics. 2022; 96(6):750-756.
Salamah T, Harefa GN. Diagnostic value and clinical significance of high-resolution ultrasonography compared to magnetic resonance imaging in diagnosing temporomandibular joint dislocation: a systematic review. Medical Journal of Indonesia. 2024 Mar; 33(1): 29-34.
Refaat MM, Yousef MI, Torky AA, Sarow ML. Ultrasonography compared to magnetic resonance imaging for the diagnosis of the temporomandibular joint disc displacement: Benha Journal of Applied Sciences. 2021 Nov; 6(6): 133-43.
Li C, Zhou J, Shi Y, Ye Z, Zhang C, Hou R, Li Z, You M. Diagnostic efficacy of quantitative ultrasonography for anterior disc displacement of the temporomandibular joint. Quant Imaging Med Surg. 2023 Oct 1;13(10):6446-6455. doi: 10.21037/qims-23-401. Epub 2023 Aug 3.
PubMed 37869327Minervini G, Nucci L, Lanza A, Femiano F, Contaldo M, Grassia V. Temporomandibular disc displacement with reduction treated with anterior repositioning splint: a 2-year clinical and magnetic resonance imaging (MRI) follow-up. J Biol Regul Homeost Agents. 2020 Jan-Feb;34(1 Suppl. 1):151-160. DENTAL SUPPLEMENT.
PubMed 32064850Talmaceanu D, Lenghel LM, Bolog N, Buduru S, Leucuta D, Rotar H. High-resolution ultrasound imaging compared to magnetic resonance imaging for temporomandibular joint disorders: An in vivo study. Eur J Radiol. 2020 Nov;132:109291. doi: 10.1016/j.ejrad.2020.109291. Epub 2020 Sep 17.
PubMed 32980724Moturi K. Internal derangements of temporomandibular joint. Temporomandibular Joint Disorders: Principles and Current Practice. 2021;: 189-207.
Palmer J, Durham J. Temporomandibular disorders. BJA Educ. 2021 Feb;21(2):44-50. doi: 10.1016/j.bjae.2020.11.001. Epub 2020 Dec 24. No abstract available.
PubMed 33889429
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Assessment in Comparison to MRI in Diagnosis of TMJ Internal Derangement
- ClinicalTrials.gov ID
- NCT06713356
- Acronym / sponsor ID
- TMJ internal derangement
- Conditions
- TMJ Internal Derangement
- Keywords
- MRI, US, TMJ, internal derangement
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 3 Dec 2024 (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.
Compare the accuracy of ultrasonography and magnetic resonance imaging in the diagnosis of temporomandibular joint internal derangements.
Detailed description
Temporomandibular disorders (TMDs) are conditions that affect the temporomandibular joint (TMJ), often leading to pain and dysfunction. The most common cause of TMJ problems is internal derangements.
The term "internal derangements" refers to conditions with the articular disc displaced from its original position on the mandibular condyle.
Disc displacement may occur anteriorly, anterolaterally, laterally, anteromedially, medially, or posteriorly, but the latter is very rare.
Anterior disc displacement (ADD) is the most common ID condition and is usually divided into two categories: with reduction and without reduction. Each category has special features during closed and opened mouth positions. Therefore, the examination should include both positions.
Clinical examination alone isn't enough to diagnose TMJ problems, therefore additional imaging tests are often needed.
Magnetic resonance imaging (MRI) is the gold standard modality, however because of its limited availability, long scan time, and high cost, it is difficult to use MRI as a screening technique.
Ultrasound (US) has been recommended as an alternate diagnostic imaging modality for TMJ problems as it is less costly, non-invasive and capable of providing real-time imaging, presents an alternative diagnostic tool. Thus, the articular disc may be seen as the patient is opening and closing their mouth
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients showing signs of TMJ internal derangements
Key inclusion criteria (1 listed)
- Patients showing signs of TMJ internal derangements
Key exclusion criteria (3 listed)
- contraindications for MRI such as claustrophobia, heart pacemaker and metallic foreign body carriers.
- patients in which the misaligned images or distortions due to motion artifacts made the interpretation of the MRI unreliable.
- Previously operated TMJ.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison between US and MRI in diagnosis of TMJ disc displacement.
Time frame: Baseline
Compare the accuracy of assessment of disc positioning by ultrasonography and magnetic resonance imaging in patients with TMJ disorders .
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Results publicationEmshoff R, Kriwanek S, Koller M, et al. Diagnostic accuracy of ultrasound in the assessment of the temporomandibular joint: a comparison with MRI. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontics. 2022; 96(6):750-756.
- Results publicationSalamah T, Harefa GN. Diagnostic value and clinical significance of high-resolution ultrasonography compared to magnetic resonance imaging in diagnosing temporomandibular joint dislocation: a systematic review. Medical Journal of Indonesia. 2024 Mar; 33(1): 29-34.
- Results publicationRefaat MM, Yousef MI, Torky AA, Sarow ML. Ultrasonography compared to magnetic resonance imaging for the diagnosis of the temporomandibular joint disc displacement: Benha Journal of Applied Sciences. 2021 Nov; 6(6): 133-43.
- Results publication: PubMed 37869327Li C, Zhou J, Shi Y, Ye Z, Zhang C, Hou R, Li Z, You M. Diagnostic efficacy of quantitative ultrasonography for anterior disc displacement of the temporomandibular joint. Quant Imaging Med Surg. 2023 Oct 1;13(10):6446-6455. doi: 10.21037/qims-23-401. Epub 2023 Aug 3.
- Results publication: PubMed 32064850Minervini G, Nucci L, Lanza A, Femiano F, Contaldo M, Grassia V. Temporomandibular disc displacement with reduction treated with anterior repositioning splint: a 2-year clinical and magnetic resonance imaging (MRI) follow-up. J Biol Regul Homeost Agents. 2020 Jan-Feb;34(1 Suppl. 1):151-160. DENTAL SUPPLEMENT.
- Results publication: PubMed 32980724Talmaceanu D, Lenghel LM, Bolog N, Buduru S, Leucuta D, Rotar H. High-resolution ultrasound imaging compared to magnetic resonance imaging for temporomandibular joint disorders: An in vivo study. Eur J Radiol. 2020 Nov;132:109291. doi: 10.1016/j.ejrad.2020.109291. Epub 2020 Sep 17.
- Results publicationMoturi K. Internal derangements of temporomandibular joint. Temporomandibular Joint Disorders: Principles and Current Practice. 2021;: 189-207.
- Results publication: PubMed 33889429Palmer J, Durham J. Temporomandibular disorders. BJA Educ. 2021 Feb;21(2):44-50. doi: 10.1016/j.bjae.2020.11.001. Epub 2020 Dec 24. No abstract available.
- 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.
Sami A. Sayed study director
Professor doctor
Omran K. Qenawy study director
Assistant professor doctor
Questions about this trial
What is this clinical trial studying?
An observational study of TMJ Internal Derangement, run by Assiut University.
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 3 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: opening soon, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Norhan A. Kamal El-Din (01152982068, norhan02468@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between US and MRI in diagnosis of TMJ disc displacement. (time frame: Baseline). 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 NCT06713356, which also lists 8 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 3 Dec 2024.