Influence of Silver Diamine Fluoride Application on the Restorative Treatment for Root Caries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Clinical outcome
研究概览
简要总结
The goal of this clinical trial is to learn the influence of prior silver diamine fluoride (SDF) application on root caries fillings.
The main questions to answer
- Compare the success of fillings placed in dental root decay that have prior SDF application and those without prior SDF application;
- Compare patient-based subjective evaluations on the two approaches mentioned above in treating root caries.
Participants will be allocated into two group
- prior SDF application before receiving root caries fillings
- directly receiving root caries fillings without any SDF application
详细描述
The aim of the proposed study is to investigate the influence of prior SDF application on the restorative treatment of root caries.
The objectives of the study are to
- Compare the success rate of restorations placed in root caries lesions that have prior SDF application and that of restorations placed without prior SDF application;
- Compare patient-based subjective evaluations on the two different approaches mentioned-above in treating root caries lesions.
Hypotheses to be tested:
- Prior SDF application increases the success rate of restorations placed in root caries;
- Patient-based subjective evaluations of the treatment outcomes are better when SDF is applied to the root caries lesions prior to restoring the lesions.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Participants, operators and investigators will not be informed of the group allocation
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older adults (aged 60 or above)
- •At least one untreated decayed dental root
排除标准
- •No self-care ability for basic daily activities
- •Teeth with severe decay (cannot be filled)
- •Teeth indicated for extraction
研究组 & 干预措施
SDF group
Participants of SDF group will be applied with SDF before placement of root caries restoration
干预措施: SDF solution application (Other)
Control group
Participants of control group will be applied with placebo (tonic water) before placement of root caries restoration
干预措施: Tonic water (Other)
结局指标
主要结局
Clinical outcome
时间窗: 24 months follow-up
Compare the success rate of restorations placed in root caries lesions that have prior SDF application or that of restorations placed without prior SDF application
次要结局
- Patient-based subjective evaluation(24 months follow-up)