Clinical and Cost-effectiveness of preventive measures in children- a community trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- • Reduction in the proportion of children developing new caries on any of the treated first permanent and deciduous molars in children aged 6-7 years over a period of 2 years
研究概览
简要总结
the aim of this community trial is to compare the clinical and cost effectiveness of sealants versus varnish in preventing dental caries in first permanent molars in 6–7-year-olds; and SMART versus conventional GIC in primary teeth of 6–7-year-old children. The trial design comprises a randomized four-arm, parallel groups in the required age group for the preventive caries techniques. Clinical procedures and assessments will be performed at two primary schools, in Trilokpuri, which is an outreach OPD of AIIMS New Delhi. In total, approximately 360 children will be recruited (90 per trial arm for 4 arms of the trial). Fluoride varnish will be applied at baseline and every 6 months through 2-year period (0, 6, 12, 18 and 24 months) and sealant will be applied at baseline and reapplication performed as required until 2 years after the initial application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 7.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged six to seven years attending public schools at Trilokpuri Children with parental consent Children with at least one fully-erupted caries-free first permanent molar determined at baseline examination.
排除标准
- •Children whose medical history or systemic illness precludes inclusion like asthma or severe allergies Children with known sensitivity to any ingredient in the dental product like methylacrylate in PFS Children with ulcerative gingivitis or stomatitis or oral infections which preclude dental procedure Children currently participating in another clinical trial involving a medicinal product.
结局指标
主要结局
• Reduction in the proportion of children developing new caries on any of the treated first permanent and deciduous molars in children aged 6-7 years over a period of 2 years
时间窗: • Reduction in the proportion of children developing new caries on any of the treated first permanent and deciduous molars in children aged 6-7 years over a period of 2 years
次要结局
未报告次要终点
研究者
BHARATHI M PUROHIT
AIIMS NEW DELHI