Efficacy of the Addition of Silver Nanoparticles to a Fluor Varnish in the Remineralization of Temporary Teeth in Patients With Trisomy 21. Randomized Clinical Trial.
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Remineralization
研究概览
简要总结
Patients with trisomy 21 are in greater danger of developing caries. It has been hypothesized that adding silver nanoparticles to fluor varnishes could promote remineralization of the teeth. A split-plot randomized controlled trial will be performed to address this question.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with trisomy 21 diagnosed through caryotype
- •Age 1 to 6 years old
- •White spot present in both upper anterior teeth
- •Parental agreement to participate in the study
排除标准
- •Hypersensibility to any of the substances used
- •Non cooperating patients
- •Caries in enamel or dentine in the upper anterior teeth
- •Leukemia or diabetes
- •Dental fluorosis present
研究组 & 干预措施
Fluor varnish
Fluor dental varnish (Fluor Protector, Ivoclar Vivadent, Principality of Liechtenstein)
干预措施: Fluor varnish (Drug)
Fluor varnish with nanoparticles
Fluor dental varnish (Fluor Protector, Ivoclar Vivadent, Principality of Liechtenstein) plus 25% 50 nm silver nanoparticles.
干预措施: Fluor varnish with nanoparticles (Drug)
结局指标
主要结局
Remineralization
时间窗: 3 months
Remineralization status will be assessed through laser fluorescence of the tooth with a Diagnodent probe (Diagnodent, Kavo, Madrid, Spain)
次要结局
未报告次要终点
研究者
Claudia Butrón Téllez Girón
Claudia Butrón-TéllezGiron, Dent.
Universidad Autonoma de San Luis Potosí