An observational study in TMJ Disorders and MRI Scans, sponsored by Universidad de los Andes, Chile. Status unknown at 1 site in Chile. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-27.
Sponsored by Universidad de los Andes, Chile · Observational
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).
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.
621 studies on the registry are indexed under Temporomandibular Joint Disorders; 161 are open to participants now.
This study's planned enrollment of 59 is below the median of 90 across 171 observational studies indexed under Temporomandibular Joint Disorders.
Browse Temporomandibular Joint Disorders studies →Universidad de los Andes, Chile is the lead sponsor of 46 studies on the registry; 10 are open to participants now.
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participants will be whites, urban, low , medium low and médium socioeconomic level, from Santiago, Chile.
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* Internal derangement in theTMJ
Exclusion Criteria:
MRI will be performed in the TMJ of participants affected with TMD
Also known as: T1 WATS
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.
Time frame: six months
Discontinuity of the TMJ FC layer
The TMJ fibrocartilage layer will be evaluated dichotomously (continuous/discontinuous).
Time frame: 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
Time frame: six month
Thickness of the TMJ fibrocartilage layer
The TMJ FC thickness will be measured (curve tool, Osirix) and will expressed in millimeters.
Time frame: 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.
Time frame: 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.
Time frame: seven months
Plan to share: No — No IPD included
Started Mar 2019 (actual). Primary completion is estimated for Apr 2019, 1 month after the start.
Of 58 non-industry observational studies under Temporomandibular Joint Disorders, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 30. This study's planned 1 month is below that.
Counting every sponsor, half of 60 studies reached it within 13 months; a quarter within 5 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Temporomandibular Joint Disorders →
Universidad de los Andes, Chile