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临床试验/NCT02775149
NCT02775149暂停不适用

Dental Erosion in Patients With Gastro-oesophageal Reflux

University of Göttingen0 个研究点目标入组 30 人开始时间: 2016年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
30
主要终点
Visual assessment of the BEWE-(basic erosive wear examination)-index

研究概览

简要总结

Not only caries but also exposure to acids can lead to loss of tooth structure. This acid-related tooth structure loss is defined as dental erosion.

A relationship between dental erosion and occurence of reflux disease was shown in numerous studies. On the one hand, patients with dental erosions frequently show reflux disease. On the other hand, many - but not all - reflux patients show dental erosions. It is believed that certain salivary parameters might explain, why not all reflux patients alike are affected of dental erosions.

The aim of this study is to analyze the relationship and the extent of occurrence of dental erosions and reflux symptoms, including investigation of certain salivary parameters.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Patients who are treated at the Clinic for Gastroenterology and Gastrointestinal Oncology and have a 24-hours pH monitoring or impedance measurement performed for medical reasons

排除标准

  • Inability to give written consent
  • Age <18 years
  • Intake of proton pump inhibitors (PPIs) if they are not discontinued at least one week before study participation

结局指标

主要结局

Visual assessment of the BEWE-(basic erosive wear examination)-index

时间窗: After removal of the probe (on second day)

次要结局

  • Determination inorganic calcium and phosphate in saliva (mmol/L).(While wearing the probe at three time points over 24h: morning, noon, evening)
  • Determination of unstimulated and stimulated saliva flow rate (ml/min).(While wearing the probe at three time points over 24h: morning, noon, evening)
  • Determination of saliva pH and buffer capacity (mol/L).(While wearing the probe at three time points over 24h: morning, noon, evening)
  • Determination of total protein content in saliva (g/L).(While wearing the probe at three time points over 24h: morning, noon, evening)
  • Measurement of salivary enzyme activity: Protease, Kollagenase/Gelatinase, Pepsin, Trypsin, and Amylase (U/mL).(While wearing the probe at three time points over 24h: morning, noon, evening)

研究者

发起方
University of Göttingen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Philipp Kanzow, Dr. med. dent., Dr. rer. medic.

Dr. med. dent.

University Medical Center Goettingen

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