TMJ Fibrocartilage Detection Using MRI

• Conditions: TMJ Disorders; MRI Scans

• Registration Number: NCT03891511
• Lead Sponsor: Universidad de los Andes, Chile

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.

Study Timeline

• Status Verified: 2019-03
• Study Start: 2019-03-18
• Study First Submitted: 2019-03-19
• Study First Submitted QC: 2019-03-24
• Last Update Submitted: 2019-03-24
• Study First Posted: 2019-03-27
• Last Update Posted: 2019-03-27
• Primary Completion: 2019-04-30
• Study Completion: 2019-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fibrocartilage Signal Intensity	six month	Six 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
Statistical analysis	seven months	The 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.
Length of the TMJ fibrocartilage layer	Six moths	The lenght of the TMJ FC layer will be measured (curve tool, Osirix) and will expressed in millimeters.
Presence of the TMJ Fibrocartilage layer	six months	The 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 layer	six months	The TMJ fibrocartilage layer will be evaluated dichotomously (continuous/discontinuous).
Thickness of the TMJ fibrocartilage layer	Six months	The TMJ FC thickness will be measured (curve tool, Osirix) and will expressed in millimeters.

Trial Locations

Locations (1)

San Vicente de Paul Centro de Diagnóstico; 🇨🇱 Santiago, Chile