WATS: TMJ Fibrocartilage Detection Using MRI

Sponsor

Universidad de los Andes, Chile (Other)

Overall Status

Unknown status

CT.gov ID

NCT03891511

Collaborator

Universidad Mayor (Other), University of Chile (Other)

Enrollment

Location

2.4

Anticipated Duration (Months)

24.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
TMJ Disorders MRI Scans	Device: MRI scann

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 Design

Study Type:

Observational

Anticipated Enrollment :

59 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 18, 2019

Anticipated Primary Completion Date :

Apr 30, 2019

Anticipated Study Completion Date :

May 30, 2019

Outcome Measures

Primary Outcome Measures

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).
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
Thickness of the TMJ fibrocartilage layer [Six months]
The TMJ FC thickness will be measured (curve tool, Osirix) and will expressed in millimeters.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Vicente de Paul Centro de Diagnóstico	Santiago		Chile	750005

Sponsors and Collaborators

Universidad de los Andes, Chile
Universidad Mayor
University of Chile

Investigators

Principal Investigator: Gustavo Moncada, PhD, UAndes, Santiago, Chile

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Gustavo Moncada, Principal investigator, Clinical Professor of Oral Rehabilitation, Universidad de los Andes, Chile

ClinicalTrials.gov Identifier:

NCT03891511

Other Study ID Numbers:

UM20-08-2

First Posted:

Mar 27, 2019

Last Update Posted:

Mar 27, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Temporomandibular Joint Disorders

Study Results

No Results Posted as of Mar 27, 2019