Back to resultsDual-echo and Inversion Recovery Magnetic Resonance Imaging Pulse Sequences in Diagnosis of Temporomandibular Disorders. Diagnostic Accuracy Study
Primary Purpose
Temporomandibular Joint Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dual echo MRI sequence
Sponsored by
About this trial
This is an interventional diagnostic trial for Temporomandibular Joint Disorders
Eligibility Criteria
Inclusion Criteria:
- Patients with pain related to temporomandibular joint.
- Patients with limited mouth opening.
Exclusion Criteria:
- 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.
Sites / Locations
- Nouran Nabil MarzabanRecruiting
Outcomes
Primary Outcome Measures
Identification of temporomandibular joint effusion.
Binary outcome measure
Secondary Outcome Measures
Delineation of temporomandibular joint disc position.
Descriptive measure: 10 - 12 - 2 o'clock position
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04348331
Brief Title
Dual-echo and Inversion Recovery Magnetic Resonance Imaging Pulse Sequences in Diagnosis of Temporomandibular Disorders. Diagnostic Accuracy Study
Official Title
Magnetic Resonance Imaging Pulse Sequences in Diagnosis of Temporomandibular Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2020 (Anticipated)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
27 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
Dual echo MRI sequence
Other Intervention Name(s)
Fluid-attenuated inversion recovery (FLAIR) MRI sequence, Short-TI Inversion Recovery (STIR) MRI sequence
Intervention Description
new MRI sequences for imaging of joints
Primary Outcome Measure Information:
Title
Identification of temporomandibular joint effusion.
Description
Binary outcome measure
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Delineation of temporomandibular joint disc position.
Description
Descriptive measure: 10 - 12 - 2 o'clock position
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with pain related to temporomandibular joint.
Patients with limited mouth opening.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nouran N Marzaban
Phone
+201006891841
Email
nouran.marzaban@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed K Zayet
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Nouran Nabil Marzaban
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nouran N Marzaban
Phone
+201006891841
Email
nouran.marzaban@dentistry.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dual-echo and Inversion Recovery Magnetic Resonance Imaging Pulse Sequences in Diagnosis of Temporomandibular Disorders. Diagnostic Accuracy Study
We'll reach out to this number within 24 hrs