Klinische Bewährung Zweier Fissurenversiegler
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Retention of the Sealant
研究概览
简要总结
Comparison of the retention of a new fissure sealant (Helioseal F Plus) and a fissure sealant that has been on the market for years in children
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •participants
- •ASA Status 1
- •all dentinal lesions are restored
- •consent of parents and patient
- •instruction and demonstration of oral hygiene
- •first and second molars of the permanent dentition
- •healthy teeth without caries
- •molars with primary lesions
排除标准
- •participants
- •no consent
- •allergies to methacrylates or other ingredients of dental products
- •molars with occlusal cavities (UniViSS score occlusal > M)
- •Molars with untreated dentinal lesions
- •premolars, incisors, deciduous teeth
- •teeth with huge occlusal restorations
- •hypomineralized teeth or other defects
研究组 & 干预措施
Helioseal F
fissure sealing with the conventional product
干预措施: fissure sealing (Device)
Helioseal F Plus
fissure sealing with the new product
干预措施: fissure sealing (Device)
结局指标
主要结局
Retention of the Sealant
时间窗: 7-28 days
grade of retention is evaluated as 0 - no fissure sealant left/present 1 complete retention 2 minimal loss of sealant (max one third) 3: central retention of the sealant, 4: almost complete loss of the sealant - less than one third is left
Retention of Sealant
时间窗: 36 months
grade of retention is evaluated as 0 - no fissure sealant left/present 1 complete retention 2 minimal loss of sealant (max one third) 3: central retention of the sealant, 4: almost complete loss of the sealant - less than one third is left
Retention of Sealant
时间窗: 12 months
grade of retention is evaluated as 0 - no fissure sealant left/present 1 complete retention 2 minimal loss of sealant (max one third) 3: central retention of the sealant, 4: almost complete loss of the sealant - less than one third is left
Retention of Sealant
时间窗: 24 months
grade of retention is evaluated as 0 - no fissure sealant left/present 1 complete retention 2 minimal loss of sealant (max one third) 3: central retention of the sealant, 4: almost complete loss of the sealant - less than one third is left
次要结局
- Caries(36 months)
- Caries(7-28 days)
- Caries(12 months)
- Caries(24 months)