跳至主要内容
临床试验/NCT02087345
NCT02087345Unknown不适用

Gastro-oesophageal Reflux in Oligosymptomatic Patients With Dental Erosion: a Longitudinal Study With pH-impedance Monitoring

Brain-Gut Research Group1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2018年12月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
试验地点
1
主要终点
The % of time with pH<4 and 5.5 during 24-hour pH-impedance

研究概览

简要总结

Dental erosions, the chemical dissolution of enamel without bacterial involvement, are considered to be an established complication of gastroesophageal reflux disease (GERD) by the Montreal global consensus statement. Given the high prevalence of dental erosions and the absence of any pH-impedance data or medical management guidelines for GERD-associated dental erosions, reflux characteristics will be characterized using questionnaires, endoscopy and esophageal pH-impedance testing, in successive patients dental erosions referred by dentists for evaluation of GERD. For assessment of the role of additional factors besides H+ activity in the refluxate, a sample of gastric juice will be aspirated during endoscopy and frozen for analysis of pepsin and other proteases. Prognostic factors for progression of dental erosions will be determined by repeating the evaluation after chronic dosing with esomeprazole 20mg twice-daily, which is prescribed to all patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The % of time with pH<4 and 5.5 during 24-hour pH-impedance

时间窗: 1 year

次要结局

  • The number of acidic and weakly acidic reflux episodes during 24-hour pH-impedance(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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