NCT01647347已完成4 期
Effects of Ultrasonic Debridement With PVP-iodine Irrigation on Post-treatment Bacteraemia Compared to Ultrasonic Debridement With Water
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- quantity of bacteraemia in central blood stream
研究概览
简要总结
The study investigates the effect of supra- and subgingival rinsing of 10% PVP prior to ultrasonic debridement in patients with periodontitis (as compared to rinsing with water) in terms of post treatment bacteraemia.
Study design: Randomized split-mouth (cross-over) study on 20 generally healthy subjects.
详细描述
Process:
Test treatment:
- 1 min mouthwash with 10% PVP-iodine
- 1 min subgingival rinsing with 10% PVP-iodine
- 1 min ultrasonic debridement with 10% PVP-iodine as cooling liquid
- blood sampling from the V.mediana cupidi
Control:
- 1 min mouthwash with water
- 1 min subgingival rinsing with water
- 1 min ultrasonic debridement with water as cooling liquid
- blood sampling from the V.mediana cupidi
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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
- 是
入选标准
- •generally healthy, adult (≥ 18 years) patients with at least two periodontal pockets of ≥ 5 mm
排除标准
- •Pregnancy
- •Lactation
- •Allergy on PVP-iodine
- •anticoagulation (exception 100mg/d acetylsalicylic acid)
- •high risc for endocarditis
- •therapeutical radiation
- •participation in other clinical studies
- •cognitive impairment (patient unable to understand aim and conduction of the study
研究组 & 干预措施
test treatment
Experimental
Test treatment:
- 1 min mouthwash with 10% PVP-iodine
- 1 min subgingival rinsing with 10% PVP-iodine
- 1 min ultrasonic debridement with 10% PVP-iodine as cooling liquid
- blood sampling from the V.mediana cupidi
干预措施: Supra- and subgingival rinsing with 10% PVP-iodine (Drug)
Control group
Placebo Comparator
Control:
- 1 min mouthwash with water
- 1 min subgingival rinsing with water
- 1 min ultrasonic debridement with water as cooling liquid
- blood sampling from the V.mediana cupidi
干预措施: Water (Other)
结局指标
主要结局
quantity of bacteraemia in central blood stream
时间窗: three minutes after starting debridement
In how many samples a bacterial contamination is found?
quality of bacteraemia in central blood stream
时间窗: three minutes after starting debridement
How many CFU are found in each blood sample?
次要结局
未报告次要终点
研究者
研究点 (1)
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