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临床试验/NCT04704128
NCT04704128已完成不适用

Identification de Voies Physiopathologiques et Cibles thérapeutiques Dans la Stomatodynie Primaire (" Burning Mouth Syndrome ") Par la métabolomique Salivaire : étude Cas/témoins

University Hospital, Tours1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2021年3月10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
53
试验地点
1
主要终点
Comparative analysis of salivary metabolomic profiles between cases (primary BMS) and controls

研究概览

简要总结

Burning mouth syndrome (BMS) is defined by a chronic oral pain affecting especially postmenopausal women. Its physiopathology is still unknown and several hypotheses have been put forward to explain this syndrome, such as neurological, hormonal or inflammatory process. The recent development of salivary metabolomic profiling in oral diseases has led to the identification of potential pathways in such disorders. The aim of this study is to analyze the salivary metabolomic in BMS patients compared to healthy controls.

详细描述

Burning mouth syndrome (BMS) is defined by a chronic oral pain affecting especially postmenopausal women. Its physiopathology is still unknown and several hypotheses have been put forward to explain this syndrome, such as neurological, hormonal or inflammatory process. The recent development of salivary metabolomic profiling in oral diseases has led to the identification of potential pathways in such disorders. The aim of this study is to analyze the salivary metabolomic in BMS patients compared to healthy controls.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • For cases : primary Burning Mouth Syndrome, based on the IHS diagnosis criteria
  • For cases : being able to realise the salivary collection
  • For controls : no primary BMS
  • For controls : being able to realise the salivary collection
  • Exclusion Criteria for both groups:
  • Treatment by antibiotics in the previous month
  • New treatment in the previous two weeks
  • Active smoking
  • Active infectious or inflammatory oral disease
  • Systemic disease that could have an impact on the salivary metabolome or on the neurological system
  • Being under legal guardianship
  • Opposition to the processing of personal data

排除标准

  • 未提供

结局指标

主要结局

Comparative analysis of salivary metabolomic profiles between cases (primary BMS) and controls

时间窗: at inclusion

metabolites will be measured in saliva by chromatography-mass spectrometry

次要结局

  • Comparative analysis of salivary neuropeptides between cases (primary BMS) and controls(at inclusion)
  • Comparative analysis of salivary hormones between cases (primary BMS) and controls(at inclusion)
  • Comparative analysis of salivary inflammatory cytokines between cases (primary BMS) and controls(at inclusion)
  • Correlation between salivary biomarkers and pain characteristics(at inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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