TMJ Fibrocartilage Detection Using MRI

MRI Scans Clinical Trial

— WATS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03891511
• Other study ID #: UM20-08-2
• Status: Recruiting
• Start date: March 18, 2019
• Est. completion date: May 30, 2019

Study information

• Verified date: March 2019
• Source: Universidad de los Andes, Chile
• Contact: Gustavo Moncada, PhD
• Phone: +56997826334
• Email: gmoncada[@]adsl.tie.cl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 59
• Est. completion date: May 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• MRI Scans
• Temporomandibular Joint Disorders
• TMJ Disorders

Intervention

Device:
• MRI scann
MRI will be performed in the TMJ of participants affected with TMD

Locations

Country	Name	City	State
Chile	San Vicente de Paul Centro de Diagnóstico	Santiago

Sponsors (3)

Lead Sponsor	Collaborator
Universidad de los Andes, Chile	Universidad Mayor, University of Chile

Country where clinical trial is conducted

Chile, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

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