Clinical and Laboratory Assessments of Effectiveness of Silver Diamine Fluoride (SDF) in Arresting Caries Among Children and Parental Satisfaction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Effectiveness of the Silver Diamine Fluoride (SDF) in arresting caries.
研究概览
简要总结
Globally, it is estimated that 2.4 billion people suffer from caries of permanent teeth and 486 million children suffer from caries of primary teeth . The highest estimate of dental caries prevalence in Saudi Arabia was 95% with maximum DMFT of 7.34 among 3-7 years old children . Also, it was found that 78% of 6-9 years old children in Dammam had caries with an average of 3.66±3.13 DMFT.
The objectives of this study are:
- To assess the effectiveness of the Silver Diamine Fluoride (SDF) in arresting caries.
- To assess the antibacterial effect of the Silver Diamine Fluoride (SDF).
- To assess parents' and children's satisfaction and acceptance.
The aims of our study are to assess the effectiveness of SDF in arresting caries in primary dentition among children visiting Imam Abdulrahman bin Faisal University in Dammam, Saudi Arabia and to assess parental acceptance and satisfaction.
The expected outcome the results of this study will help in understanding the effectiveness SDF in arresting dental caries in this target population especially that it was recently approved for clinical use in Saudi Arabia.
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
- None
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children between four and six years of age.
- •Have at least two active dentin carious lesions on the primary teeth meeting the International Caries Detection and Assessment System (ICDAS) score 5 or
- •Should not have periapical infection, root resorption or widening in the periodontal ligament space.
排除标准
- •Participants who have systemic or neurological diseases.
- •Tooth abscess, pain on percussion, symptoms of pulpal involvement or mobility,
- •Allergic to silver or any dental material to be used.
- •Unable to attend follow-up visits.
结局指标
主要结局
Effectiveness of the Silver Diamine Fluoride (SDF) in arresting caries.
时间窗: 2 years
Caries arresting rate: total number of arrested teeth/ total number of treated teeth.
次要结局
- Clinical changes of dentinal lesion: in the hardness and softness.(2 years)
- Parents satisfaction(2 years)
- The antibacterial effect of the Silver Diamine Fluoride (SDF).(2 years)
研究者
Khalood Saeed Bahammam
Intern at Imam Abdulrahman Bin Faisal University
Imam Abdulrahman Bin Faisal University