CTRI/2025/11/096961尚未招募4 期
Plasma and Salivary Assessment for Silver Levels Post-Silver Diamine Fluoride (SDF) Application in Children Aged 2-6 Years: A Prospective Cohort Study
Unit of Pedodontics and Preventive dentistry Oral Health Sciences Centre PGIMER1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年11月26日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To estimate the levels of silver in plasma serum and saliva at baseline before SDF application at 4 hours and 1 month of SDF application using Inductively coupled plasma mass spectrometry ICPMS
研究概览
简要总结
A prospective cohort study to evaluate silver levels in plasma and saliva of children aged 2 to 6 years following application of 38 percent Silver Diamine Fluoride SDF on carious teeth and blood and saliva samples will be collected at baseline 4 hours of application and 1 month post SDF application to assess pharmacokinetic changes of silver ions
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •Children reporting to the Unit of Pedodontics and Preventive Dentistry Oral Health Sciences Centre to receive dental treatment Multiple carious teeth requiring SDF application Parental consent obtained to be part of the study.
排除标准
- •Presence of any known systemic diseases or syndromic cases Patients with a history of allergic reactions to silver or products History of any fluoride treatment in the past 3 months.
结局指标
主要结局
To estimate the levels of silver in plasma serum and saliva at baseline before SDF application at 4 hours and 1 month of SDF application using Inductively coupled plasma mass spectrometry ICPMS
时间窗: Baseline before SDF application | 4 hours after SDF application | 1 month after SDF application
次要结局
- To evaluate arrest of caries post-SDF application using ICDAS-II Criteria and to assess any localized adverse effect of SDF application(Baseline before SDF application)
研究者
Dr Sadia Iqbal
PGIMER
研究点 (1)
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