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临床试验/NCT06213675
NCT06213675撤回不适用

A Randomized Controlled Study to Explore the Effect of Intra-articular Injection on Temporomandibular Joint Dysfunction

Zeng Changhao1 个研究点 分布在 1 个国家开始时间: 2024年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Friction Index

研究概览

简要总结

The goal of this clinical trial is to study about the clinical effect of Intra-articular Injection on Temporomandibular Joint Dysfunction

The main question it aims to answer is:

• Can Intra-articular Injection help improve the Temporomandibular Joint Dysfunction Participants will be randomly assigned into the experimental group and the control group, all under comprehensive treatment. The experimental group will be given Intra-articular Injection additionally, The study lasts 15 days for each patient. Researchers will compare the assessments between the two groups to see if Intra-articular Injection can help improve the Temporomandibular Joint Dysfunction

详细描述

The background of Temporomandibular Joint Dysfunction is that it is one of the common diseases in the oral and maxillofacial region, and it is the most common among temporomandibular joint diseases. It is more prevalent in young adults, with the highest prevalence rate at 20-30 years old.

The goal of this clinical trial is to study about the clinical effect of Intra-articular Injection on Temporomandibular Joint Dysfunction

The main question it aims to answer is:

• Can Intra-articular Injection help improve the Temporomandibular Joint Dysfunction Participants will be randomly assigned into the experimental group and the control group, all under comprehensive treatment. The experimental group will be given Intra-articular Injection additionally, The study lasts 15 days for each patient. Researchers will compare the assessments between the two groups to see if Intra-articular Injection can help improve the Temporomandibular Joint Dysfunction

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 (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Presence of significant temporomandibular disorder clinical symptoms.
  • Meeting the diagnostic criteria for Temporomandibular Joint Dysfunction and confirmed by X-ray examination.
  • Patients voluntarily participate in this study and provide signed informed consent.
  • Normal cognitive function

排除标准

  • Rheumatic, rheumatoid, or other severe systemic diseases.
  • Infectious temporomandibular joint arthritis or joint tumors.
  • Individuals who have recently received joint injection treatment or photodynamic therapy.

结局指标

主要结局

Friction Index

时间窗: day 1 and day 15

Friction Index is used to assess temporomandibular function. The total scores range from 0 to 57, with higher scores indicating more severe temporomandibular dysfunction.

次要结局

  • The maximum mouth opening limit(day 1 and day 15)
  • Mann Assessment of Swallowing Ability(day 1 and day 15)
  • The Visual Analog Scale(day 1 and day 15)

研究者

发起方
Zeng Changhao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zeng Changhao

Research Director

People's Hospital of Zhengzhou University

研究点 (1)

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