TMJ Fibrocartilage Detection Using MRI (WATS)

March 24, 2019 updated by: Gustavo Moncada, Universidad de los Andes, Chile

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile, 750005
        • Recruiting
        • San Vicente de Paul Centro de Diagnóstico
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gustavo Moncada, PhD
        • Sub-Investigator:
          • Daniel Cortes, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

participants will be whites, urban, low , medium low and médium socioeconomic level, from Santiago, Chile.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de los Andes, Chile

Collaborators

University of Chile
Universidad Mayor

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2019

Primary Completion (Anticipated)

April 30, 2019

Study Completion (Anticipated)

May 30, 2019

Study Registration Dates

First Submitted

March 19, 2019

First Submitted That Met QC Criteria

March 24, 2019

First Posted (Actual)

March 27, 2019

Study Record Updates

Last Update Posted (Actual)

March 27, 2019

Last Update Submitted That Met QC Criteria

March 24, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UM20-08-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD included

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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