A Randomized Clinical Trial of Oral Health Promotion Interventions Among Patients Following Stroke
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Change in plaque scores over course of trial
研究概览
简要总结
The main aim of this oral health intervention project is to compare the effect of providing 1) professional oral hygiene instruction alone versus 2) professional oral hygiene instruction plus adjunctive Chlorhexidine mouth rinse versus 3) professional oral hygiene instruction plus adjunctive assisted tooth brushing and Chlorhexidine mouth rinse, on the oral health condition, the general health condition and health-related quality of life (HRQoL) of patients with stroke who are receiving hospital-based rehabilitation. An additional aim is to assess potential longer term oral intervention-related health and HRQoL outcomes.
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
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 50 years and over
- •Moderate to severe stroke (Barthel Index >/= 70)
- •Admitted to Rehabilitation Unit within 7 days
排除标准
- •Patients with naso-gastric feeding tube
- •Edentulous patients
- •Patients with communication difficulties
结局指标
主要结局
Change in plaque scores over course of trial
时间窗: Three week in-hospital rehabilitation period
次要结局
- Change in oral health-related quality of life over course of trial(Three week in-hospital rehabilitation period)
- Change in gingival bleeding scores over course of trial(three week in-hospital rehabilitation period)
- Change in oral colonization by Staphylococcus aureus over course of trial(Three week in-hospital rehabilitation period)
- Change in oral colonization by yeasts over course of trial(Three week in-hospital rehabilitation period)
- Change in oral colonization by aerobic and facultatively anaerobic Gram-negative bacilli over course of trial(Three week in-hospital rehabilitation period)
- Change in health-related quality of life over course of trial(three week in-hospital rehabilitation period)
研究者
Dr. Otto Lok-Tao Lam
Clinical assistant professor
The University of Hong Kong