Professional Oral Care and Staff Education to Improve Oral Hygiene in Critically Ill Patients: A Prospective Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 2
- 主要终点
- Change in Simplified Oral Hygiene Index (OHI-S) over time
研究概览
简要总结
This study evaluated oral health in critically ill patients admitted to two intensive care units in Budapest, Hungary, and examined whether professional oral care and education of intensive care staff could improve oral hygiene. A total of 161 adult patients were included. Dentate patients in the first phase were randomly assigned to receive either professional oral care provided by dentists or standard oral care provided by ICU nursing staff. Total edentulous patients were included in a separate group. After a structured oral care education programme was provided to ICU staff, subsequently enrolled patients were included in a separate post-education group. Oral hygiene and gingival inflammation were assessed repeatedly during the ICU stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years of age) admitted to one of the participating intensive care units.
- •Expected ICU stay of at least 48 hours.
- •Informed consent obtained from the patient or their legally authorized representative.
排除标准
- •ICU stay shorter than 48 hours.
- •Refusal to participate or inability to obtain informed consent from the patient or their legally authorized representative.
- •Conditions associated with a high risk of bleeding that contraindicated oral examination or oral care.
研究组 & 干预措施
Professional Oral Care
Dentate patients randomly assigned during the first study phase to receive professional oral care provided by calibrated dentists three times weekly. Oral care was performed using a rotary-oscillatory electric toothbrush and fluoride toothpaste, including cleaning of occlusal, buccal, and lingual tooth surfaces, followed by oral rinsing with sterile water.
干预措施: Professional Oral Care (Behavioral)
Standard oral care
Dentate patients randomly assigned during the first study phase to receive standard oral care provided by ICU nursing staff according to local clinical practice. Standard care was performed twice daily.
干预措施: Standard Oral Care (Behavioral)
Upskill
Dentate patients enrolled after implementation of a structured staff education programme. The programme addressed oral hygiene, recommendations for prevention of ventilator-associated pneumonia, and the recommended oral care protocol, including toothbrushing with toothpaste and oral rinsing. Patients subsequently received standard oral care according to local ICU practice.
干预措施: Standard Oral Care (Behavioral)
Upskill
Dentate patients enrolled after implementation of a structured staff education programme. The programme addressed oral hygiene, recommendations for prevention of ventilator-associated pneumonia, and the recommended oral care protocol, including toothbrushing with toothpaste and oral rinsing. Patients subsequently received standard oral care according to local ICU practice.
干预措施: ICU Staff Oral Care Education (Behavioral)
Total edentulous
Total edentulous patients included in a separate non-randomized cohort. These patients received standard oral care according to local ICU practice.
干预措施: Standard Oral Care (Behavioral)
结局指标
主要结局
Change in Simplified Oral Hygiene Index (OHI-S) over time
时间窗: Baseline and three times weekly during the ICU stay, through ICU discharge, an average of 30 days.
Oral hygiene was assessed using the Simplified Oral Hygiene Index (OHI-S), which ranges from 0 to 6, with higher scores indicating poorer oral hygiene. OHI-S scores were compared between study groups and across repeated examinations during the ICU stay.
次要结局
- Change in gingivitis prevalence over time(Baseline and three times weekly during the ICU stay, through ICU discharge, an average of 30 days.)
- Incidence of ventilator-associated pneumonia (VAP)(Through ICU discharge, an average of 30 days.)
- Duration of mechanical ventilation(From initiation of invasive mechanical ventilation until discontinuation or death, whichever occurred first, assessed up to 43 days.)
- ICU length of stay(From ICU admission until ICU discharge or death, whichever occurred first, assessed up to 66 days.)
- Hospital length of stay(From hospital admission until hospital discharge or death, whichever occurred first, assessed up to 103 days.)
- All-cause mortality(Up to 103 days after ICU admission.)