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临床试验/NCT06824766
NCT06824766已完成不适用

Investigation of the Relationship Between Autonomic Nervous System Activity and Biomechanical Characteristics of Chewing Muscles in Bruxers

Bandırma Onyedi Eylül University1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
89
试验地点
1
主要终点
Visual Analogue Scale

研究概览

简要总结

The aim of this study was to determine the relationship between autonomic nervous system activity and tonus, stiffness and elasticity of temporalis and masseter muscles in individuals with bruxism and to compare them with healthy controls.

详细描述

Individuals diagnosed with bruxism and healthy individuals as a control group will be included in the study. Firstly, the purpose of the research and evaluation methods will be explained to the participants. Individuals who volunteer to participate in the study and meet the inclusion criteria will be included. Approval will be obtained from the individuals to be evaluated with the 'Informed Voluntary Consent Form'. Individuals will then fill in the Descriptive Data Form. The intensity of pain in the masticatory muscles of all participants at rest and during chewing will be measured by Visual Analogue Scale, Autonomic Nervous System activity (heart rate variables) will be measured by Polar H10 chest strap, and the tonus, stiffness and elasticity of the temporalis and masseter muscles will be measured by Myoton device. The evaluations are planned to take an average of 20 minutes for each participant. The evaluations of the participants will be made only once and will not be evaluated again.

研究设计

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

入排标准

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

入选标准

  • •Diagnosed with bruxism between the ages of 18-65,
  • •A history of bruxism for at least 6 months,
  • •Individuals with masseter muscle pain ≥4 at rest and during mastication
  • •Control group: Healthy individuals aged 18-65 years

排除标准

  • •Masseter botox application in the last 6 months,
  • •With regular use of analgesics and anti-inflammatories affecting the OSS,
  • •Smokes 20 or more cigarettes daily,
  • •With regular alcohol use of 1-2 glasses per day,
  • •Daily coffee consumption of 6 cups or more,
  • •Cardiovascular, respiratory and central nervous system diseases,
  • •Presence of infection or tumoural structures within intraoral structures,
  • •Multiple ear piercings,
  • •With TMJ disc displacement and joint degeneration,
  • •Cervical or TMJ fracture, systemic disease, musculoskeletal problem with evidence of specific pathological condition,
  • •Any surgical operation related to cervical or TMJ problem,
  • •Less than 6 months of cervical or TMJ-related physiotherapy and rehabilitation services,
  • •The one with facial paralysis,
  • •Diagnosed psychiatric illness
  • •Participants who have communication difficulties in speaking and understanding Turkish or who are unable to understand the exercises

研究组 & 干预措施

Bruxers

Individuals with bruxism

干预措施: Visual Analogue Scale (Other)

Bruxers

Individuals with bruxism

干预措施: Autonomic nervous system activity assessment (Other)

Bruxers

Individuals with bruxism

干预措施: Masticatory muscles assessment (Other)

Control group

Healthy volunteers

干预措施: Visual Analogue Scale (Other)

Control group

Healthy volunteers

干预措施: Autonomic nervous system activity assessment (Other)

Control group

Healthy volunteers

干预措施: Masticatory muscles assessment (Other)

结局指标

主要结局

Visual Analogue Scale

时间窗: March 1, 2025- June 1, 2025

The pain intensity of the participants will be assessed using the Visual Analogue Scale, which is a simple, reliable and short-term method commonly used to measure pain intensity in the clinic. The participant is told that the most severe pain he/she experiences is 10 and if there is no pain, the pain intensity is 0. The participant will be asked to tick a number between 0 and 10 corresponding to the intensity of pain felt in the masticatory muscles at rest and during chewing.

Autonomic nervous system activity assessment

时间窗: March 1, 2025- June 1, 2025

All participants included in the study will undergo a 5-minute test with the Polar H10 chest strap device for autonomic nervous system activity assessment. The data obtained after the measurement will be analysed with Kubios software.

Masticatory muscles biomechanical properties assessment

时间窗: March 1, 2025- June 1, 2025

The Myoton PRO device will be used to objectively assess the biomechanical properties of the participants' masticatory muscles. The masticatory muscles will be evaluated bilaterally in the sitting position. Three measurements will be recorded at one second intervals and the average value will be used for analysis.

次要结局

未报告次要终点

研究者

发起方
Bandırma Onyedi Eylül University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hazel Çelik Güzel

Assist. Prof. Dr

Bandırma Onyedi Eylül University

研究点 (1)

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