Pilot Study on Oral Health Status Chairside Mouthrinse Test in Finnish Adolescents and Cost Effectiveness of the Test
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 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
- 是
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
研究组 & 干预措施
aMMP-8 chairside test
Test group. The aMMP-8 chairside mouth rinse test is performed for the test group.It identifies adolescents with poor oral hygiene at risk for subclinical periodontitis without detectable and visible manifestations of the illness, such as periodontal deepened pockets.
干预措施: aMMP-8 chairside test (Diagnostic Test)
No test
The other group is control group. No test administered.
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
Teija Raivisto
Principal Investigator
University of Helsinki