Fluoride Concentration in Inter-proximal Fluid From Dental Sealants.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,776
- 试验地点
- 4
- 主要终点
- Inter-proximal fluid fluoride concentration
研究概览
简要总结
The hypothesis of this study is that the concentration of fluoride in oral interproximal fluids would increase more after using high-viscosity GIC as pit and fissure sealant, compared to Resin-Based sealants containing fluoride and RB sealants without fluoride content. To validate this hypothesis a randomized clinical trial was designed and performed in schoolchildren in order to evaluate fluoride release in inter-proximal fluid in vivo after the placement of three types of sealants: high-viscosity GIC, Resin-Based sealants containing fluoride and RB sealants without fluoride content.
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
- 6 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria are: year of birth between 2000 and 2002, informed consent signed by parents/guardians, presence of at least two permanent first molars completely erupted.
排除标准
- •The exclusion criteria are: demineralized lesions and hypomineralized permanent molar, carious lesions or presence of filling on the occlusal surface of the first permanent molar, fixed orthodontic treatment.
结局指标
主要结局
Inter-proximal fluid fluoride concentration
时间窗: 21 days after application
Inter-proximal fluid was collected with a paper point in the mesial inter-proximal space of the sealed tooth for 15 seconds. Each sample was prepared for the analysis as follow: added of 0.5 ml TISAB III to reach a pH 5 and shaken with magnetic stirrer thermostated at 25°C for 15 seconds. 100 ml of the solution was then placed on a Petri dish for the analysis. Fluoride concentration was carried out with an Orion model 96.09 fluoride ion selective electrode and an Orion model 900200 double junction plastic body Ag/AgCl reference electrode with an Orion model 290 mV digital meter.
次要结局
- caries incidence(24 months)
研究者
Guglielmo Campus
Associate professor of Community Dentistry
Università degli Studi di Sassari