跳至主要内容
临床试验/NCT03891511
NCT03891511Unknown不适用

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

Universidad de los Andes, Chile1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2019年3月18日最近更新:
适应症

试验速览

阶段
不适用
入组人数
59
试验地点
1
主要终点
Fibrocartilage Signal Intensity

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • * Internal derangement in theTMJ

排除标准

  • Cardiac pacemaker
  • Cochlear implant
  • Intracranial vascular clips
  • Metal particles in the orbit
  • Head or face trauma
  • Generalized osteoarthrosis
  • Joint hyperlaxity
  • Congenital malformity
  • Facial cysts
  • Facial tumors
  • Previous TMJ surgery

结局指标

主要结局

Fibrocartilage Signal Intensity

时间窗: 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

Statistical analysis

时间窗: 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.

Length of the TMJ fibrocartilage layer

时间窗: Six moths

The lenght of the TMJ FC layer will be measured (curve tool, Osirix) and will expressed in millimeters.

Presence of the TMJ Fibrocartilage layer

时间窗: 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

时间窗: six months

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

Thickness of the TMJ fibrocartilage layer

时间窗: Six months

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gustavo Moncada

Principal investigator, Clinical Professor of Oral Rehabilitation

Universidad de los Andes, Chile

研究点 (1)

Loading locations...

相似试验