Temporomandibular Joint DisordersNCT04348331
Dual-echo and Inversion Recovery Magnetic Resonance Imaging Pulse Sequences in Diagnosis of Temporomandibular Disorders. Diagnostic Accuracy Study
A study testing Dual echo MRI sequence in people with Temporomandibular Joint Disorders, run by Cairo University at 1 site in Egypt.
Trial summary
In the present study, investigators are going to investigate the potential of inversion recovery (fluid attenuated inversion recovery -FLAIR and short-TI Inversion Recovery -STIR) sequence images to demonstrate joint effusion, compared to T2-weighted images. Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Dual echo MRI sequence
- How many people
- 27 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2020to Jun 2021
- Phase
- Interventional
- 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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with pain related to temporomandibular joint.
- Patients with limited mouth opening.
Who cannot join
- Patients with pain related to temporomandibular joint for less than one month duration.
- Patients with limited mouth opening for less than one month duration.
- Patients with history of TMJ surgical intervention.
- Patients with history of TMJ arthrocentesis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Nouran Nabil Marzaban
Cairo
Nouran N Marzaban, +201006891841, nouran.marzaban@dentistry.cu.edu.eg
About this study
Official title: Magnetic Resonance Imaging Pulse Sequences in Diagnosis of Temporomandibular Disorders
In the present study, investigators are going to investigate the potential of inversion recovery (fluid attenuated inversion recovery -FLAIR and short-TI Inversion Recovery -STIR) sequence images to demonstrate joint effusion, compared to T2-weighted images.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Dual echo MRI sequence
- 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.
Dual echo MRI sequenceDiagnostic test
Also called Fluid-attenuated inversion recovery (FLAIR) MRI sequence, Short-TI Inversion Recovery (STIR) MRI sequence
new MRI sequences for imaging of joints
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of temporomandibular joint effusion.
Binary outcome measure
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Delineation of temporomandibular joint disc position.
Descriptive measure: 10 - 12 - 2 o'clock position
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study startApr 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Khalifa Zayet, Cairo University
- Investigators
- Mohamed K Zayet, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348331
- Sponsor's protocol ID
- ORAD 7:1:1
- Status last verified
- Apr 2020
- First submitted
- 9 Apr 2020
- Last updated
- 16 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging Pulse Sequences in Diagnosis of Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT04348331
- Acronym / sponsor ID
- ORAD 7:1:1
- Conditions
- Temporomandibular Joint Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 16 Apr 2020 (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.
In the present study, investigators are going to investigate the potential of inversion recovery (fluid attenuated inversion recovery -FLAIR and short-TI Inversion Recovery -STIR) sequence images to demonstrate joint effusion, compared to T2-weighted images.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients with pain related to temporomandibular joint.
- Patients with limited mouth opening.
Key exclusion criteria (4 listed)
- Patients with pain related to temporomandibular joint for less than one month duration.
- Patients with limited mouth opening for less than one month duration.
- Patients with history of TMJ surgical intervention.
- Patients with history of TMJ arthrocentesis.
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 |
|---|---|---|
| Dual echo MRI sequenceAlso: Fluid-attenuated inversion recovery (FLAIR) MRI sequence, Short-TI Inversion Recovery (STIR) MRI sequencenew MRI sequences for imaging of joints | Diagnostic test | – |
Primary outcome
Identification of temporomandibular joint effusion.
Time frame: through study completion, an average of 1 year
Binary outcome measure
1 secondary outcome
Delineation of temporomandibular joint disc position.
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Mohamed K Zayet study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual echo MRI sequence in people with Temporomandibular Joint Disorders, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 Apr 2020. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nouran N Marzaban (+201006891841, nouran.marzaban@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of temporomandibular joint effusion. (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2020.