Evaluation of Streptococcus Mutans Reduction by Silver Diamine Fluoride vs. Fluoride Varnish: A Split-Mouth Study in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in Streptococcus mutans levels measured by Dentocult SM Strip Mutans test at baseline, 1 week, 1 month, and 3 months
研究概览
简要总结
This randomized split-mouth clinical trial will compare the effectiveness of 38% silver diamine fluoride (SDF) versus 5% sodium fluoride varnish (FV) in reducing salivary Streptococcus mutans levels in children with bilateral caries. Each participant will receive SDF on one side of the mouth and FV on the contralateral side. The primary outcome is change in Dentocult SM Strip Mutans scores in plaque over 3 months. Secondary outcomes include plaque index, bleeding on probing, and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The operator and participants could not be blinded because 38% silver diamine fluoride (SDF) produces visible black staining of carious lesions. The outcome assessor for Streptococcus mutans (Dentocult SM test) was blinded; plaque samples were coded, and the assessor had no knowledge of treatment allocation.
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 3-8 years; cooperative (Frankl ≥2).
- •≥2 contralateral primary molars with active dentin caries (ICDAS 3-5) of comparable severity.
- •Parent/guardian consent; child assent when appropriate.
排除标准
- •Silver allergy; ulcerative gingivitis/stomatitis.
- •Systemic antibiotics within 4 weeks.
- •Fixed appliances interfering with plaque assessment.
- •Conditions precluding safe participation per clinician judgment.
研究组 & 干预措施
Silver Diamine Fluoride (SDF)
Application of 38% silver diamine fluoride (44,800 ppm F) to all eligible dentin caries lesions on the assigned side of the mouth. Single application per manufacturer's instructions.
干预措施: Silver Diamine Fluoride (38%) (Drug)
Fluoride Varnish (FV)
Application of 5% sodium fluoride varnish (22,600 ppm F) to all eligible dentin caries lesions on the contralateral side of the mouth. Single application per manufacturer's instructions.
干预措施: Sodium Fluoride Varnish (5%) (Drug)
结局指标
主要结局
Change in Streptococcus mutans levels measured by Dentocult SM Strip Mutans test at baseline, 1 week, 1 month, and 3 months
时间窗: 3 month
Streptococcus mutans levels will be assessed using the Dentocult SM Strip Mutans test (Orion Diagnostica/Aidian). The test provides a semi-quantitative estimate of salivary S. mutans based on colony density on a selective culture strip.
次要结局
未报告次要终点
研究者
ِAhmed kamel Abdel Naser soliman
Assistant Lecturer
Assiut University