Effect of Smoking on Saliva Composition and the Development of Dental Erosion - an In-situ Study
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 specimens by extraoral erosion (nmol/Square Millimeter).
研究概览
简要总结
The aim of this study is to investigate whether smoking is associated with changes in salivary composition and/or predisposition to erosion.
Healthy volunteers are observationally wearing an intraoral device with both bovine tooth specimens (enamel and dentin) and resin specimens twice for two hours each. Afterwards, specimens are eroded extraorally and calcium release into the acid is measured.
Total protein concentration and protein composition of the salivary pellicles on the resin samples are measured. Additionally, salivary parameters (unstimulated and stimulated saliva flow rate, pH, buffer capacity, total protein content and protein composition as well as concentration of inorganic calcium, phosphate, and fluoride) are measured.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers aged between 20 and 50 years who are able to give written consent
排除标准
- •Non-fulfillment of the inclusion criteria
- •Intake of medications or diseases altering salivary secretion
- •Refusal to use fluoridated toothpastes
- •Known allergies to substances used in the study
- •Orthodontic treatment or malfunction which does not allow wearing an intraoral device
研究组 & 干预措施
Smokers
Volunteers smoking at least 10 cigarettes per day
干预措施: Use of fluoridated toothpaste (Other)
Smokers
Volunteers smoking at least 10 cigarettes per day
干预措施: Wearing of an intraoral device with bovine tooth samples (Other)
Smokers
Volunteers smoking at least 10 cigarettes per day
干预措施: Wearing of an intraoral device with resin samples (Other)
Non-smokers
Non-smoking volunteers
干预措施: Use of fluoridated toothpaste (Other)
Non-smokers
Non-smoking volunteers
干预措施: Wearing of an intraoral device with bovine tooth samples (Other)
Non-smokers
Non-smoking volunteers
干预措施: Wearing of an intraoral device with resin samples (Other)
结局指标
主要结局
Calcium release from bovine enamel and dentin specimens 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 inorganic calcium (mmol/L), phosphate (mmol/L) and fluoride (µmol/L) in saliva.(Saliva samples are collected for 5 min each on three visits.)
- Determination of salivary buffer capacity (pH).(Saliva samples are collected for 5 min each on three visits.)
- Determination of unstimulated and stimulated saliva flow rate (mL/min).(Saliva samples are collected for 5 min each on three visits.)
- Determination of total protein concentration (ng/Square Millimeter) and protein composition (qualitatively) within the salivary pellicles.(Immediately after the intraoral device with resin samples has been worn once for two hours.)
- Determination of saliva pH (pH).(Saliva samples are collected for 5 min each on three visits.)
- Determination of total protein content (mg/L) and protein composition (qualitatively) in saliva.(Saliva samples are collected for 5 min each on three visits.)
研究者
Philipp Kanzow, Prof. Dr. med. dent., Dr. rer. medic.
Senior Dental Practitioner
University Medical Center Goettingen