The Effectiveness of Oral Health Promotion on Pneumonia Complicating Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- The prevalence of pneumonia complicating stroke
研究概览
简要总结
To investigate the evidence for the integration of oral health promotion as part of interdisciplinary stroke rehabilitation.
详细描述
Pneumonia complicating stroke is very difficult to manage and has a very poor prognosis, leading to a significantly higher risk of death. Oral opportunistic pathogens have been reported to be associated with the incidence of pneumonia among non-stroke immunocompromised subjects. Preliminary studies found that patients with stroke had higher carriage rates of oral opportunistic pathogens than healthy subjects. Therefore, investigators hypothesize that pneumonia complicating stroke is associated with oral opportunistic pathogens, and oral health promotion interventions may reduce the incidence of pneumonia complicating stroke via its effects on the species and relative abundance of oral opportunistic pathogens. In order to prove this, investigators need to (1) firstly conduct a randomized controlled trial to confirm whether oral health promotion is able to reduce the levels of plaque, and the incidence of pneumonia complicating stroke at clinical level; (2) secondly employ metagenomics analysis to compare oral rinse samples and respiratory samples, and to identify pneumonia-associated "oral opportunistic pathogens group"; (3) finally elucidate how oral health promotion influences the species and relative abundance of oral opportunistic pathogens. This proposed study will provide evidence for the integration of oral health promotion as part of interdisciplinary stroke rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •having onset of stroke within 3 days and free of any post-stroke complication
- •having moderate to severe functional disability- Barthel Index (BI) scores of <70
- •being conscious and respiring voluntarily without ventilator
- •not having any lung disease and lower respiratory infection
- •not have an indwelling naso-gastric feeding tubes
- •having dysphagia as showed by GUSS test (The Gugging Swallowing Screen, GUSS)
- •having normal cognitive ability or mild impairment- Mini Mental State Examination (MMSE) >18
- •having ability to follow instruction (as an assessment of compliance of oral health intervention)
- •not having systemic administration of antibiotics
- •not being edentulous
排除标准
- •mild disability (Barthel Index > 70)
- •having normal swallowing function
- •edentulous
- •having an indwelling naso-gastric feeding tubes
- •having communication disorders, unable to cooperate with family caregivers for oral health promotion
结局指标
主要结局
The prevalence of pneumonia complicating stroke
时间窗: 1 week
To calculate and compare the incidence of pneumonia between interventional group and control group, to identify whether the intervention approach could reduce the short-term incidence after the baseline.
次要结局
- Plaque Index(1 month, 3 months, 6 months)
- The prevalence of pneumonia complicating stroke(1 month, 3 months, 6 months)
- Gingival Bleeding Index(1 month, 3 months, 6 months)
- the Oral Health Impact Profile 14 (OHIP-14)(1 month, 3 months, 6 months)
- Metagenomic(3 days, 5 days, 7 days, and 1 month, 3 months, 6 months)
- the Short Form Health Survey 12 (SF-12)(1 month, 3 months, 6 months)
- the Geriatric Oral Health Assessment Index (GOHAI)(1 month, 3 months, 6 months)
研究者
Ya Zhang
Principal Investigator
Anhui Medical University