A Stimulator of the Salivary Excretion Based on Physical Vibration of the Parotid Glands.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- sialometry
研究概览
简要总结
Oral dryness causes significant health problems both functional (difficulty speaking, chewing and swallowing) and structural problems in teeth (increased number of infections) and oral mucosa. The main objective of this study is to show an alternative treatment to help to stimulate the salivary secretion thus improving the quality of life of the patient. In this study, a salivary stimulation equipment using vibrotactile stimuli is shown. The system has been placed bilaterally in the parotid glands and assessed the efficacy of the salivary secretion by sialometry before and after the stimulation. The new proposal is capable of stimulating salivary secretion, in a significative way after 7 minutes of use, at least in the cases analyzed, and fulfills low-cost, easy-to-use and safe technical restrictions. In this setting, this paper suggests the performance of a deep clinical trial to measure the exact efficacy of the prototype and the times and frequencies needed to state the optimal treatment depending in each case
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sialometria <01,mL /5 min
- •Test Thomson
排除标准
- •Not signing informed consent
- •Bad medical status
结局指标
主要结局
sialometry
时间窗: up to 4 weeks
The test we will use consists of measuring the amount of saliva produced during a period of 5 mins when a millimetre strip of paper with a dimension of 1 cm wide and 17 cm is applied.
次要结局
未报告次要终点
研究者
Pia Lopez Jornet
Investigador principal
Universidad de Murcia
