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临床试验/NCT05118100
NCT05118100已完成不适用

Effectiveness of Adhesive Containing MDPB: a Practice-based Clinical Trial

Radboud University Medical Center0 个研究点目标入组 5,102 人开始时间: 2015年1月1日最近更新:
适应症
干预措施
相关药物

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

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)

研究者

申办方类型
Other
责任方
Sponsor

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