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临床试验/NCT07273123
NCT07273123招募中不适用

Effect of Sugar-Free Chewing Gum Mastication on Fatigue of the Masticatory Muscles in Young Adults With and Without Temporomandibular Joint Disorders

University of Milan2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年10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
招募中
入组人数
30
试验地点
2
主要终点
Self-reported (subjective) fatigue after prolonged sugar-free chewing gum mastication

研究概览

简要总结

This case-control study investigates fatigue induced by prolonged gum mastication in individuals with temporomandibular disorders (TMD). The study addresses two primary questions:

How does self-reported fatigue, measured with a visual analogue scale (VAS), change during sustained chewing? How do static and dynamic surface electromyographic (sEMG) parameters evolve over the same period? Participants with TMD will be compared with healthy controls to determine group differences in perceived fatigue and EMG responses.

All participants will undergo baseline EMG assessment, then chew sugar-free gum continuously for 3 minutes, alternating sides without rest. After each 3-minute interval, static and dynamic EMG recordings will be obtained and participants will rate their fatigue on the VAS. This cycle may be repeated up to six times (maximum 18 minutes). Participants are free to stop chewing at any time if fatigue becomes intolerable.

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
19 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • (both groups):
  • Age 19-35 years
  • Chewing-gum users, even occasional
  • Good general health
  • Good oral health
  • Inclusion criteria (Healthy controls):
  • - no diagnosed temporomandibular joint disorders
  • Inclusion criteria (study group)
  • - diagnosed temporomandibular joint disorders

排除标准

  • (both groups):
  • Non chewing gum users
  • History of neurological disorders
  • History of musculoskeletal diseases
  • History of facial or cervical injuries
  • Presence of cervical pain
  • Two or more missing teeth
  • Current treatment with fixed or removable orthodontic appliances
  • Active periodontal disease
  • Presence of cavitated carious lesions

研究组 & 干预措施

Case group (subjects with TMD)

This group contains subjects with temporomandibular disorders

干预措施: Mastication of sugar-free chewing gum (Other)

Control group (TMD-free subjects)

This group contains healthy subjects without temporomandibular disorders

干预措施: Mastication of sugar-free chewing gum (Other)

结局指标

主要结局

Self-reported (subjective) fatigue after prolonged sugar-free chewing gum mastication

时间窗: The whole session has a maximum duration of 18 minutes, assessments are done every 3 minutes

Self-reported (subjective) fatigue after prolonged sugar-free chewing gum mastication

时间窗: 18 minutes

次要结局

  • Changes of static and dynamic surface electromyography (sEMG) parameters after prolonged mastication of sugar-free chewing gum(The whole session has a maximum duration of 18 minutes, assessments are done every 3 minutes)
  • Changes of static and dynamic surface electromyography (sEMG) parameters after prolonged mastication of sugar-free chewing gum(18 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aesha Allam

DDS, Doctor, principal investigator

University of Milan

研究点 (2)

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