跳至主要内容
临床试验/NCT05362201
NCT05362201已完成不适用

Application of the Visualization of Treatment Objective (VTO) Analyses in the Treatment of the Temporomandibular Joint Disc Displacement

Fujian Medical University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
temporomandibular joint function

研究概览

简要总结

This study conducted a randomized controlled clinical trial to evaluate the effect of the the therapeutic position of the anterior repositioning splint determined by VTO analyse compared with traditional method for the treatment of the Anterior Disk Displacement with Reduction of the Temporomandibular Joint.

详细描述

A randomised clinical trial was conducted with 20 patients diagnosed with ADDWR through RDC/TMD and they were randomly allocated into the group 1(traditional group):the therapeutic position of the ARS were determinded by the "minimum protrusive position",which was the traditional method to fabricate the anterior repositioning splints;group2(digitial group): the therapeutic position of the ARS were determinded by the VTO analyse,first,the participants were constructed to take CBCT and MRI scans,the ideal therapeutic position of the ARS were located in which the temporomandibular joint space distribute well and the condylar recapture the disc,the dentist could determine the amount of condylar movement and performed VTO analyse by assessing the CBCT and MRI scans ,then it could easily realize the final condylar movements with the application of the dental articulator.

They were followed-up in the baseline,1 month,2 and 3 months after the inserted of the splints using the Craniomandibular Index (CMI) for temporomandibular joint function and PHQ-9,GAD-7 for psychological assessments,the tmj space and disc-condylar angle were measured through the CBCT and MRI scans,before and after ARS therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • anterior disc displacement with reduction (ADDWR) confirmed by magnetic resonance imaging (MRI)
  • Classified as ASA 1 or 2
  • Willing to participate and sign a written informed consent form.

排除标准

  • pregnant women
  • heart pace disorders and epilepsy

结局指标

主要结局

temporomandibular joint function

时间窗: up to three months

the Craniomandibular Index (CMI) was used to assess the temporomandibular joint function after the inserted of the splints.

次要结局

  • psychological assessment the PHQ-9(three months)
  • psychological assessment GAD-7(three months)
  • disc-condyle angle(three months)
  • temporomandibular joint space(three months)

研究者

发起方
Fujian Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hao Yu

Fujian Medical University

Fujian Medical University

研究点 (1)

Loading locations...

相似试验