跳至主要内容
临床试验/NCT05129111
NCT05129111已完成不适用

A Stimulator of the Salivary Excretion Based on Physical Vibration of the Parotid Glands.

Universidad de Murcia2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年5月12日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pia Lopez Jornet

Investigador principal

Universidad de Murcia

研究点 (2)

Loading locations...

相似试验