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临床试验/NCT02780973
NCT02780973已完成不适用

Influence of Gender Specific Differences of Saliva Composition on the Development of Dental Erosion - an In-situ Study

University of Göttingen1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年2月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Calcium release from bovine enamel and dentin samples by extraoral erosion (nmol/Square Millimeter).

研究概览

简要总结

Healthy volunteers are observationally wearing an intraoral device with bovine tooth samples once for two hours. Afterwards, Calcium release from the bovine enamel and dentin samples is measured after extraoral erosion.

Total protein concentration within the formed salivary pellicles on the bovine samples is determined. Further Salivary parameters (unstimulated and stimulated saliva flow rate, pH, buffer capacity, albumin and total protein content as well as concentration of inorganic calcium, phosphate and fluoride) are being measured.

The aim of this study is to investigate whether gender differences in the salivary composition correlate with predisposition to erosion.

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
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy probands aged between 20 and 40 years who are able to give written consent

排除标准

  • Non-fulfillment of the inclusion criteria
  • Hyposalivation / xerostomia (unstimulated saliva < 0.3 mL/min, stimulated saliva < 0.7 mL/min)
  • Intake of any medication (except contraceptives in women)
  • Pregnant or lactating women
  • Known allergies to substances used in the study
  • Orthodontic treatment or malfunction which doesn't allow to wear an intraoral device

结局指标

主要结局

Calcium release from bovine enamel and dentin samples by extraoral erosion (nmol/Square Millimeter).

时间窗: Immediately after the intraoral device has been worn once for two hours.

次要结局

  • Determination of saliva pH.(Saliva samples are collected for 5 min each on two visits.)
  • Determination of inorganic calcium (mmol/l), phosphate (mmol/L) and fluoride (µmol/L) in saliva.(Saliva samples are collected for 5 min each on two visits.)
  • Determination of unstimulated and stimulated saliva flow rate (mL/min).(Saliva samples are collected for 5 min each on two visits.)
  • Determination of salivary buffer capacity.(Saliva samples are collected for 5 min each on two visits.)
  • Determination of total protein concentration in the formed salivary pellicles (ng/Square Millimeter).(Immediately after the intraoral device has been worn once for two hours.)
  • Determination of albumin (mg/L) in saliva.(Saliva samples are collected for 5 min each on two visits.)
  • Determination of total protein content (mg/L) in saliva.(Saliva samples are collected for 5 min each on two visits.)

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, PD Dr. med. dent., Dr. rer. medic.

Senior Dental Practitioner

University Medical Center Goettingen

研究点 (1)

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