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临床试验/NCT04139863
NCT04139863Unknown不适用

Pilot Study on Oral Health Status Chairside Mouthrinse Test in Finnish Adolescents and Cost Effectiveness of the Test

University of Helsinki2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
2
主要终点
aMMP-8 test

研究概览

简要总结

The aim is to study whether participants at risk could be identified using an aMMP-8 chairside mouth rinse test and to study if oral health and health behaviour is linked to the test result in Finnish adolescents.

详细描述

Adolescents (14-15-year-olds) are randomly divided to control group and test group. Chairside mouth rinse test for aMMP-8 is performed for the test group. Two groups are compared with each other.

Participants are asked to fill a questionnaire which consists of questions concerning oral hygiene habits, tobacco products, alcohol, drug and snuff use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
14 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All 8 class (aged 14-15 years) pupils in Jukola, Hämeenlinna, Finland
  • Written informed consent from the participants and their parents (one of them)

排除标准

  • No written consent to the study

结局指标

主要结局

aMMP-8 test

时间窗: 1 year

Mouth rinse samples are analysed by method for chair-side diagnostic testing: the aMMP-8 specific lateral-flow point-of-care (PoC)/chair-side test (PerioSafe®, Dentognostics GmbH, Jena, Germany). The result is provided in 5 minutes and is graded by eye as positive or negative. One line means that the test is negative but successfully done and two lines the test is positive.

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

Teija Raivisto

Principal Investigator

University of Helsinki

研究点 (2)

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