NCT05255913已完成不适用
Effectiveness of Nano-silver Fluoride and Silver Diamine Fluoride for Arresting Early Childhood Caries (a Randomized Clinical Trial)
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
- 360
- 试验地点
- 1
- 主要终点
- caries arrest
研究概览
简要总结
Aim of the study: To evaluate and compare the clinical cariostatic efficacy of NSF with 38% SDF solution after sex and twelve months in arresting ECC lesions.
The Null hypothesis will be that no statistically significant difference will be detected between the two groups in the arrest of carious lesions in children with ECC.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children younger than 4 years old.
- •The presence of at least one active carious lesion on a primary tooth, with scores 3 and higher (according to the International Detection and Assessment System- ICDAS II)
- •Completion of an informed consent to participate in the study.
排除标准
- •Children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling and/or abscess, obvious discoloration of the tooth and premature hypermobility.
- •Parental refusal to participate in the study.
- •Allergy or sensitivity to silver or any of the materials included in the study.
研究组 & 干预措施
group 1
Experimental
干预措施: Nanosilver (Drug)
group 2
Active Comparator
干预措施: Silver diamine fluoride (Drug)
结局指标
主要结局
caries arrest
时间窗: 6 months and 1 year
percentage of arresting caries in primary teeth
次要结局
- Comparing parental satisfaction and adverse effects with interventions(6 months)
- Evaluating oral health related quality of life of children and their families.(6 months and 1 year)
- Assessing caries increment on remaining teeth in the oral cavity other than the tooth/ teeth receiving the preventive agent(6 months and 1 year)
研究者
Maryam Quritum
dentist
Alexandria University
研究点 (1)
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