Effectiveness of Adhesive Containing MDPB: a Practice-based Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,102
- 主要终点
- Restoration survival
研究概览
简要总结
9 general practices in the Netherlands were provided with two composite resin adhesives, each for a period of 9 months. One contained MDPB (Adhesive P), and the other one was used as a control (Adhesive S). Patient's age, SES, and caries risk, as well as tooth type/number, reason for restoration placement, used restorative material and bonding agent, and affected surfaces were recorded. All interventions carried out on these teeth in the next 6 years were extracted from the electronic patient records, along with their date, type, reason, and surfaces. Two dependent variables were defined: general failure, and failure due to secondary caries. All data handling and statistical analyses were carried out in R 4.0.5.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Needing at least one dental restoration
排除标准
- •Opted out of data collection
研究组 & 干预措施
Protect Bond
Restoration placed using Clearfil Protect Bond adhesive (Kuraray Noritake, Osaka, Japan) , which contains the antibacterial monomer MDPB (12-Methacryloyloxydodecylpyridiniumbromide)
干预措施: Clearfil Protect Bond (Drug)
SE Bond
Restoration placed using Clearfil SEBond adhesive (Kuraray Noritake, Osaka, Japan)
干预措施: Clearfil SE Bond (Drug)
结局指标
主要结局
Restoration survival
时间窗: up to 5 years
Time in years restoration has survived without needing dental re-intervention
次要结局
- Failure through caries(up to 5 years)
