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临床试验/NCT07053865
NCT07053865已完成不适用

Electromyographic Assessment of Sleep Bruxism in Patients With Stage III and IV Periodontitis: Findings From a Cross-sectional Study.

University of Siena1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年6月27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
40
试验地点
1
主要终点
Sleep Bruxism Work Index (BWI)

研究概览

简要总结

This study aims to investigate the association between periodontitis Stage III and IV and the intensity and duration of sleep bruxism episodes. Surface electromyography (EMG) of the masseter muscle will be used to instrumentally assess sleep bruxism in patients with and without periodontal disease

详细描述

The purpose of this cross-sectional study is to evaluate whether patients with Stage III and IV periodontitis exhibit differences in sleep bruxism activity compared to individuals without periodontal disease. Participants will undergo comprehensive periodontal assessment and 24-hour EMG recording of the masseter muscle using a portable device. Bruxism activity will be quantified using the Bruxism Work Index (BWI) and Bruxism Time Index (BTI). The study aims to clarify the potential relationship between periodontal inflammation and masticatory muscle activity during sleep, following standardized diagnostic and recording protocols

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
28 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 28 and 50 years
  • Ability to perform adequate oral hygiene
  • Willingness to participate and sign informed consent
  • For periodontitis group: Diagnosis of Stage III or IV periodontitis
  • For control group: Absence of periodontal disease

排除标准

  • Use of removable dentures
  • Ongoing orthodontic treatment
  • Temporomandibular disorders (TMD) or orofacial pain
  • Use of medications affecting muscle activity
  • Systemic or psychiatric disorders

结局指标

主要结局

Sleep Bruxism Work Index (BWI)

时间窗: Within 24 hours after EMG device application

BWI is calculated as the percentage of muscle work exerted during bruxism-related masticatory activity relative to the theoretical maximum work. It will be used to assess the intensity of sleep bruxism based on EMG recordings of the masseter muscle

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

Nicola Discepoli

Associate Professor

University of Siena

研究点 (1)

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