TMJ Fibrocartilage Detection Using MRI

NCT03891511 | Unknown DMC FDA Device

• 1 other identifier: UM20-08-2
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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).

Conditions

TMJ Disorders; MRI Scans

Outcome Measures

Primary Outcomes (6)

• 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

• Discontinuity of the TMJ FC layer

  The TMJ fibrocartilage layer will be evaluated dichotomously (continuous/discontinuous).

  six months

• 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

• Thickness of the TMJ fibrocartilage layer

  The TMJ FC thickness will be measured (curve tool, Osirix) and will expressed in millimeters.

  Six months

• 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

• 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

Interventions

MRI scann DEVICE

MRI will be performed in the TMJ of participants affected with TMD

Also known as: T1 WATS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• \* Internal derangement in theTMJ

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead
• Universidad Mayor: collaborator
• University of Chile: collaborator

Study Sites (1)

San Vicente de Paul Centro de Diagnóstico

Santiago, 750005, Chile

RECRUITING

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Human, aged 18-60 years old, female and male, affected with temporo mandibular disorders

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Gustavo Moncada, PhD

  UAndes, Santiago, Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gustavo Moncada, PhD

CONTACT

+56997826334; gmoncada@adsl.tie.cl

Daniel Cortés, MS

CONTACT

+56 991233 9154; drcortessylvester@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Clinical Professor of Oral Rehabilitation

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 27, 2019
• Study Start: March 18, 2019
• Primary Completion: April 30, 2019
• Study Completion: May 30, 2019
• Last Updated: March 27, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)