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TMJ Fibrocartilage Detection Using MRI (WATS)

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ClinicalTrials.gov Identifier: NCT03891511
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Collaborators:
Universidad Mayor
University of Chile
Information provided by (Responsible Party):
Gustavo Moncada, 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).

Condition or disease Intervention/treatment
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.

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Study Type : Observational
Estimated 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 : March 18, 2019
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: MRI scann
    MRI will be performed in the TMJ of participants affected with TMD
    Other Name: T1 WATS


Primary Outcome Measures :
  1. 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.

  2. Discontinuity of the TMJ FC layer [ Time Frame: six months ]
    The TMJ fibrocartilage layer will be evaluated dichotomously (continuous/discontinuous).

  3. 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


  4. 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.

  5. 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.

  6. 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.



Biospecimen Retention:   Samples Without DNA
Human, aged 18-60 years old, female and male, affected with temporo mandibular disorders


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
participants will be whites, urban, low , medium low and médium socioeconomic level, from Santiago, Chile.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891511


Contacts
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Contact: Gustavo Moncada, PhD +56997826334 gmoncada@adsl.tie.cl
Contact: Daniel Cortés, MS +56 991233 9154 drcortessylvester@gmail.com

Locations
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Chile
San Vicente de Paul Centro de Diagnóstico Recruiting
Santiago, Chile, 750005
Contact: Steffi Eckartd, MDS    +562 2943 3900    infoimagen@sanvicentedepaul.cl   
Contact: Monica Bunster, BA    +562 2943 3900    areacomercial@sanvicentedepaul.cl   
Principal Investigator: Gustavo Moncada, PhD         
Sub-Investigator: Daniel Cortes, MS         
Sponsors and Collaborators
Universidad de los Andes, Chile
Universidad Mayor
University of Chile
Investigators
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Principal Investigator: Gustavo Moncada, PhD UAndes, Santiago, Chile

Publications of Results:

Other Publications:
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Responsible Party: Gustavo Moncada, Principal investigator, Clinical Professor of Oral Rehabilitation, Universidad de los Andes, Chile
ClinicalTrials.gov Identifier: NCT03891511     History of Changes
Other Study ID Numbers: UM20-08-2
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD included

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Temporomandibular Joint Disorders
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases