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TMJ Fibrocartilage Detection Using MRI

TMJ Fibrocartilage Detection Using 3D Fat-Suppressed Spoiled Gradient-Echo Magnetic Resonance Imaging

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03891511
Acronym
WATS
Enrollment
59
Registered
2019-03-27
Start date
2019-03-18
Completion date
2019-05-30
Last updated
2019-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MRI Scans, TMJ Disorders

Brief summary

Objective: The aims of this study will be to detect the fibrocartilage layer (FC) of the human temporomandibular joint (TMJ) using 3D SPGR (Spoiled GRASS sequence) (T1 WATS) sequence and to compare these results with those of conventional magnetic resonance imaging (DP, T2 MRI) sequences in patients with temporomandibular disorders (TMD).

Detailed description

This prospective and observational study will focused on analyzing morphological characteristics of the fibrocartilage layer of the TMJ based on the MRI scans of 59 patients. All 118 TMJs of these patients will be suitable for analysis, (range: 18-60 years old), females and males affected by TMD and did not undergo previous TMJ treatment.

Interventions

DEVICEMRI scann

MRI will be performed in the TMJ of participants affected with TMD

Sponsors

Universidad Mayor
CollaboratorOTHER
University of Chile
CollaboratorOTHER
Universidad de los Andes, Chile
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

\* Internal derangement in theTMJ

Exclusion criteria

* Cardiac pacemaker * Cochlear implant * Intracranial vascular clips * Metal particles in the orbit * Head or face trauma * Gout * Generalized osteoarthrosis * Joint hyperlaxity * Congenital malformity * Facial cysts * Facial tumors * Previous TMJ surgery

Design outcomes

Primary

MeasureTime frameDescription
Presence of the TMJ Fibrocartilage layersix monthsThe fibrocartilage layer will be evaluated dichotomously (absent/present) Patients will be examined using bilateral MRI (Phillips Intera 1,5 T, Sense Flex S Dual Coil) in the sagittal PD-weighted, T2-weighted and T1-weighted WATS, all in the oblique axis of the mandible condyle and with a closed mouth; dynamic gradient-echo at open mouth at 10 mm, 20 mm and 30 mm of the interincisal distance. Additionally, a coronal PD-weighted sequence with the mouth closed will be performed. Of each TMJ will be taken with 8×8 cm FOV and 0.2 cm spacing. All sequences will carried out using the same equipment and on the same day.
Discontinuity of the TMJ FC layersix monthsThe TMJ fibrocartilage layer will be evaluated dichotomously (continuous/discontinuous).
Fibrocartilage Signal Intensitysix monthSix regions of interest (ROIs) will be measured in the fibrocartilage layer of each TMJ. (anterior 0°, center 45° and posterior 90°), three in the mandibular condyle and three in the temporal fossa. The fibrocartilage signal intensity in each ROI will be expressed as the mean value of intensity units (Osirix). All measurements will be made in a simple blinded system by four different observers (ML, MN, CV, GZ) (chi-square test for interobserver agreement: p˂0.05). Measurements will be made separately in the three MRI sequences (length tool, Osirix Imaging software). In all MRI sequences, TMJ will be magnified at a zoom of 3.6. For the T1 WATS sequence, the window width will be set at 90 intensity Units (IU) (all values above +90 Hounsfield Unit (HU) will be white), and the window level was 80 (IU) (all values below +80 HU will be black). All images will be measured and stored in DICOM format., lengt
Thickness of the TMJ fibrocartilage layerSix monthsThe TMJ FC thickness will be measured (curve tool, Osirix) and will expressed in millimeters.
Length of the TMJ fibrocartilage layerSix mothsThe lenght of the TMJ FC layer will be measured (curve tool, Osirix) and will expressed in millimeters.
Statistical analysisseven monthsThe Shapiro-Wilk test and Levene's test will be performed to assess normality of data distribution and homogeneity of variance of the measurements, respectively. To determine the relationship between the presence or absence of fibrocartilage and the different sequences, Fisher's exact test will be used. The thickness, length and signal intensity of the fibrocartilage layer will be expressed as a mean value, separated by MRI sequence, and will be analyzed using descriptive statistics. SPSS v14.0 for Windows, statistical software will be used to perform data analysis.

Countries

Chile

Contacts

Primary ContactGustavo Moncada, PhD
gmoncada@adsl.tie.cl+56997826334
Backup ContactDaniel Cortés, MS
drcortessylvester@gmail.com+56 991233 9154

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026