A Randomized Clinical Trial on the Use of Sodium Fluoride Varnish and Silver Diamine Fluoride Solution for Arresting Active Dental Caries in Preschool Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 371
- 试验地点
- 1
- 主要终点
- change in hardness of dental caries lesion
研究概览
简要总结
This randomized clinical trial aims to compare the effectiveness of three topical fluoride application protocols, namely three applications of a 30% SDF solution at yearly or weekly interval and three applications of a 5% NaF varnish at weekly interval, in arresting dental caries in the primary teeth of preschool children over 30 months.
详细描述
This randomized clinical trial aims to compare the effectiveness of three topical fluoride application protocols, namely three applications of a 30% SDF solution at yearly or weekly interval and three applications of a 5% NaF varnish at weekly interval, in arresting dental caries in the primary teeth of preschool children over 30 months.
Preschool children attending the first year of the kindergartens will be invited to join this study. An invitation letter will be sent to the parents explaining the purpose and procedures of this study. Parental consent will be sought. Generally healthy children who have at least one tooth with untreated caries into dentine will be invited to participate and they will be followed for 30 months.
Dental clinical examination of the children will be conducted by a calibrated dentist in the kindergarten. Tooth and oral hygiene condition will be recorded. A parental questionnaire will be administered at baseline and at the 30-month follow-up visits regarding their children's socio-economic background and oral health related behaviours. The questionnaire will also assess parental satisfaction with their child's oral health and dental aesthetics.
All active dental caries lesions of the participant children will be treated if possible. The children will be categorized as having a high or a low caries rate. They will then be allocated by a stratified randomization method to one of the three study groups:
Group A - 3 applications of a 30% SDF solution at yearly interval Group B - 3 applications of a 30% SDF solution at weekly interval Group C - 3 applications of a 5% NaF varnish at weekly interval
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Generally healthy children who have at least one tooth with untreated caries into dentine
排除标准
- •Children who have major systemic diseases or on long-term medication, are uncooperative or refuse the treatment will be excluded.
研究组 & 干预措施
SDF regular
3 applications of a 30% SDF solution will be applied onto the surface of dental caries lesions by a small brush regularly once a year
干预措施: SDF solution (Device)
SDF intensive
3 applications of a 30% SDF solution will be applied onto the surface of dental caries lesions by a small brush at weekly interval at baseline
干预措施: SDF solution (Device)
NaF varnish
3 applications of a 5% NaF varnish will be applied onto the surface of dental caries lesions by a small brush at weekly interval at baseline
干预措施: NaF varnish (Device)
结局指标
主要结局
change in hardness of dental caries lesion
时间窗: baseline and 30 months
change from a soft active dental caries lesion at baseline to a hardened arrested caries lesion upon gentle probing with a dental explorer at the evaluation is regarded as a positive treatment outcome
次要结局
未报告次要终点
