The Effectiveness of Silver Diamine Fluoride Treatment With Different Post-treatment Protocols in Arresting Dental Caries in Primary Teeth of Preschool Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- Caries status
研究概览
简要总结
To compare the effectiveness of the semi-annual application of 38% SDF with two post-treatment protocols in arresting dental caries in preschool children
详细描述
Methods: The randomized clinical trial will recruit 254 healthy kindergarten children aged 3-4 years old with caries and with parental consent. All the tooth surfaces with carious lesions will receive the semi-annual application of 38% SDF solution. After the treatment, children will be allocated to two groups by an independent research assistant. Two post-treatment protocols are as follows.
Group A - Children are instructed to rinse their teeth with a cup of water containing about 50 ml immediately after SDF treatment. Afterwards, no post-treatment protocol is given to children.
Group B - Children are instructed not to eat and drink for at least 30 minutes. Clinical examinations after 6-months will be conducted to assess whether the caries is arrested. Information on confounding factors, such as oral hygiene habits and the use of other fluoride agents, will be collected through a parental questionnaire at the baseline and 12-months follow-up. The analysis will determine the significance of differences between the percentage of arrested caries at the various follow-ups.
Significance: This study will help determine the optimal post-op treatment in SDF treatment. The study provides an evidence-based protocol for the use of silver diamine fluoride to arrest tooth decay in primary teeth of young children.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •3-5 year old children attending the first to the third year of kindergarten;
- •free from any systemic conditions and generally healthy;
- •parents sign informed consent;
- •having at least 1 tooth with cavitated dentine carious lesion
排除标准
- •are uncooperative to accept oral examination or treatment;
- •have a significant systematic disease or long-term medications;
- •have abnormal dentition.
- •Teeth having signs or symptoms of irreversible pulpitis and non-vitality will be excluded.
研究组 & 干预措施
Group A- immediately rinse mouth
Children are instructed to rinse their teeth with a cup of water containing about 50 ml immediately after SDF treatment. Afterwards, no post-treatment protocol is given to children.
干预措施: 38% SDF treatment (Drug)
Group A- immediately rinse mouth
Children are instructed to rinse their teeth with a cup of water containing about 50 ml immediately after SDF treatment. Afterwards, no post-treatment protocol is given to children.
干预措施: rinse mouth immediately after SDF treatment (Behavioral)
Group B- not to rinse for at least 30 minutes
Children are instructed not to eat and drink for at least 30 minutes.
干预措施: 38% SDF treatment (Drug)
Group B- not to rinse for at least 30 minutes
Children are instructed not to eat and drink for at least 30 minutes.
干预措施: not to rinse for at least 30 minutes after SDF treatment (Behavioral)
结局指标
主要结局
Caries status
时间窗: at 12-month follow-up
The proportion of the soft (active) carious tooth lesion surfaces that harden (arrested) at 12 months of follow-up will be measured
次要结局
未报告次要终点
研究者
Chun Hung Chu
Professor
The University of Hong Kong