NCT03775772Unknown不适用
Oral Health, Bite Force and Dementia - A Randomized Controlled Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Oral Health (dental examination)
研究概览
简要总结
Study aims: The primary aim is to identify influencing variables on oral hygiene / oral health and bite force in patients with dementia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •> 59 years
- •no acute processes being present
- •no known cranio-mandibular dysorder (CMD) or finding of any CMD during study participation
- •non or Maximum of one dental hygiene treatment in the last 12 months
排除标准
- •younger than 60 years
- •acute processes in the oral-facial Region
- •known CDM case
- •more than one dental hygiene treatment in the last 12 months
研究组 & 干预措施
Oral Health - Test Group
Other
- study population is randomly assigned to control and test group
干预措施: Oral Health (Procedure)
Bite Force/Chewing Efficacy-Test Group
Other
- study population is randomly assigned to control and test group
干预措施: Bite Force (Procedure)
结局指标
主要结局
Oral Health (dental examination)
时间窗: 1 year
Decayed, Missing, Filled - Index (dmf/t)
Chewing function I (examination with force gauge meter)
时间窗: 1 year
Bite Force (Bite Force Meter in Newton)
次要结局
- Chewing function II (two-coloured chewing gum to test efficacy)(1 year)
- Nutrition I (questionnaire/ assessment of nutritional state)(1 year)
- Nutrition II (examination for weight and body-size)(1 year)
研究者
研究点 (2)
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