跳至主要内容
临床试验/NCT06941727
NCT06941727招募中不适用

Association Between Maximum Mouth Opening and Masseter Muscle Elasticity in Oral Cancer Patients: A Study Using Sonographic Elastography

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年5月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
1
主要终点
Masseter muscle elasticity

研究概览

简要总结

The study aims to assess the hardness of masticatory muscles in post-surgical oral cancer patients using strain elastography ultrasound, calculating the masseter elasticity index and exploring its association with maximum interincisal mouth opening. Furthermore, the study incorporates exercise training to analyze whether changes in masseter hardness can serve as an objective indicator for predicting the improvement of trismus.

详细描述

This study aims to evaluate the hardness of masticatory muscles in patients who have undergone surgery for oral cancer, using strain elastography ultrasound. Specifically, the research focuses on measuring the elasticity of the masseter muscle by calculating the masseter elasticity index (MEI) and analyzing its correlation with maximum interincisal mouth opening (MIO). Since trismus, or restricted mouth opening, is a common post-surgical complication affecting oral function and quality of life, understanding the relationship between muscle elasticity and jaw mobility is crucial. Additionally, the study incorporates a structured exercise training program designed to improve jaw function in these patients. By monitoring changes in masseter muscle hardness before and after the intervention, the research aims to determine whether variations in muscle elasticity can serve as an objective indicator for predicting improvements in trismus.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Newly diagnosed oral cancer patients who are scheduled to receive cancer-related treatments (e.g., oral cancer surgery, radiotherapy, chemotherapy, or chemoradiotherapy).
  • •Age between 20 and 65 years.

排除标准

  • •Could not communicate.
  • •Had any disorder that could influence movement performance.

结局指标

主要结局

Masseter muscle elasticity

时间窗: Pre-intervention, 8 weeks post-intervention

The masseter elasticity index is calculated as the ratio of the average elasticity of the masseter muscle to that of the isolation-coupling Pad (icPad).

Maximum interincisal mouth opening

时间窗: Pre-intervention, 8 weeks post-intervention

Maximum interincisal mouth opening is measured using a mouth-opening ruler, placed at the edges of the upper and lower central incisors to determine the distance.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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