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临床试验/NCT05876169
NCT05876169Enrolling By Invitation不适用

How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?

Umeå University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年9月6日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
40
试验地点
1
主要终点
Change in Electromyography (EMG)

研究概览

简要总结

In a prospective longitudinal study design, details in jaw-neck kinematics and electromyography (EMG) activity changes in patients (women and men) referred for surgical correction of basal relations between the maxilla and mandible over time; pre-operative and during follow-up 8 weeks and 18 months after surgical correction will be evaluated. The results will contribute with novel insights on jaw-neck motor function before, in short- and long-term after the surgical process. We will have blinded evaluation of outcomes.

详细描述

Consecutive patients referred to department of Oral and Maxillofacial Surgery, Umeå University Hospital for corrective maxillofacial-mandibular surgery, will offer opportunity to be included in the study. Expected number of patients: 20 - 25 patients annually. Blinded evaluation will be pre-operative and during follow-up 8 weeks and 18 months after surgical correction.

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
16 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in Electromyography (EMG)

时间窗: Preoperatively, postoperatively 8 weeks, 18 months

Muscle activity in micro-Volt in jaw and neck muscles bilaterally

Change in Maximum voluntary occlusal bite force (MVOBF)

时间窗: Preoperatively, postoperatively 8 weeks, 18 months

Newton (N)

Change in Occlusal contact area

时间窗: Preoperatively, postoperatively 8 weeks, 18 months

mm2

Change in Kinematic outcome variables

时间窗: Preoperatively, postoperatively 8 weeks, 18 months

Jaw and head movement amplitudes (mm)

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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