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临床试验/NCT05522114
NCT05522114已完成不适用

Evaluation of Patient Specific Guide Accuracy for TMJ Superior Joint Space Injection.

Al-Azhar University2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2022年4月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
2
主要终点
Vertical displacement of needle tip

研究概览

简要总结

This study is designed to evaluate the accuracy of planned needle position using patient specific guide during TMJ superior joint space injection.

详细描述

The actual position of the needle evaluated in comparison to the planned one using MSCT while the patient wearing the customized needle guide.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with intra-articular TMJ disorder according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
  • Patients who would not respond to conservative treatment as the first line of treatment.

排除标准

  • Lactating, pregnant or planning pregnancy women.
  • Known hypersensitivity to hyaluronic acid or clear biocompatible photopolymer resin.

结局指标

主要结局

Vertical displacement of needle tip

时间窗: 1 month

The vertical displacement of the actual needle tip in comparison to the planned one (mm).

Overall needle tip dislocation

时间窗: 1 month

The distance between the planned and actual needle tips (mm).

Angle of deviation

时间窗: 1 month

The angle (°) between the planned and actual needle measured.

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

AbdElKader Ahmed Hyder Mohamed

Principal Investigator

Al-Azhar University

研究点 (2)

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