A six month clinical evaluation of Silver Diamine Fluoride and Atraumatic Restorative Treatment for treating dental caries.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Intact restoration and no secondary caries
研究概览
简要总结
Silver Diamine Fluoride(SDF) has been popularised for its ability to stop dental caries formation and concurrently arrest caries progression.This approach does not require caries excavation using instruments, in addition silver has many antimicrobial properties and fluoride which helps in remineralisation. The Atraumatic Restorative Treatment (ART) is a pain free, minimal intervention approach where only hand instruments are used to remove carious tooth substance before the cavity is restored and any adjacent enamel fissures are sealed with conventional , self-hardening Glass Ionomer Cement(GIC).Thus WHO recommends ART as the treatment option for dental caries in areas with limited access to dental care.
Hence, this study is being conducted to evaluate if SDF can be used as an effective caries restoration option in school children as opposed to ART, as it removes the use of hand instruments used in ART for caries excavation. Therefore it can be used in children with anxiety for dental treatments and also be done by trained auxillaries instead of dentists in rural areas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •International Caries Detection and Assessment System (ICDAS) code V and VI not involving the pulp.
排除标准
- •Medically compromised patients.
- •dental caries involving pulp.
- •Pain and mobility in the tooth.
结局指标
主要结局
Intact restoration and no secondary caries
时间窗: 6 months
次要结局
- 1.Loss of restoration(2.Discoloration)
