跳至主要内容
临床试验/NCT05309681
NCT05309681已完成不适用

Salivary Melatonin Levels and Sleep Quality in Patients With Burning Mouth Syndrome

University of Zagreb1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2021年1月7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
45
试验地点
1
主要终点
determining the level of salivary melatonin

研究概览

简要总结

Burning mouth syndrome is an idiopathic condition characterized by symptoms burning and / or pain of the oral mucosa with an orderly clinical finding. So far not found a unique way of treatment. It is a diagnosis that impairs the quality of life of patients, and consequently it can affect the quality of sleep. Melatonin is a hormone secreted from pineal gland and regulates the day-night rhythm of man, and whose production in the body decreases aging. The level of melatonin in saliva correlates well with the level of melatonin in plasma, therefore they are advantages of determining from saliva painlessness and non-invasiveness of the procedure itself. The purpose of this study was to compare the level of melatonin in saliva and the quality of sleep with help of the Epworth Sleepiness Scale in patients with burning mouth syndrome and control groups of patients without subjective oral disorders and with an orderly clinical finding.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • female patients
  • primary burning mouth syndrome
  • without oral lesions

排除标准

  • secondary burning mouth syndrome
  • male gender
  • patients with oral lesions

结局指标

主要结局

determining the level of salivary melatonin

时间窗: January 2021-July 2021

The level of salivary melatonin will be determined in frozen samples of unstimulated saliva samples

次要结局

  • determining the difference in Epworth's sleepiness scale(January 2021-July 2021)

研究者

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

Božana Lončar Brzak

Assistant Professor at the Department of Oral Medicine

University of Zagreb

研究点 (1)

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