Cost-efficacy of Silver Diammine Fluoride to Control Caries Lesions in Erupting Permanent First Molars - Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Caries progression
研究概览
简要总结
This study aims to evaluate the cost-effectiveness of 30% silver diammine fluoride in the treatment of clinically caries lesions in enamel, on occlusal surfaces in first permanent molars compared to a control group that performs only the cross-toothbrushing technique and evaluate the acceptability and satisfaction of patients and responsible for the application of the solution cariostatic.
详细描述
The sample will be comprised of 183 patients between 4 to 7 year-old, who present at least occlusal surface with initial caries lesion (ICDAS 1, 2, 3). Patients will be randomly allocated to treatments, according to the technique to be employed: (I) 30% diamine silver fluoride, (II) cross-toothbrushing technique. Will also be guided and motivated individual, where these children will be taught the technique of brushing conventional. It will be given to all patients a toothbrush. In times of reassessment, the degree of wear of the bristles of these brushes will be evaluated in order to infer the use of the same. The teeth will be evaluated by clinical and exams at baseline and after 3, 6, 12, 18 and 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •erupting permanent molars (that are not in full occlusion)
- •not special children
- •children who present at least occlusal surface with initial caries lesion (ICDAS 1, 2, 3)
排除标准
- •presence of cavitated caries lesions
- •presence of enamel defects (hypoplasias)
结局指标
主要结局
Caries progression
时间窗: 12 months
次要结局
- duration(24 months)
- cost(24 months)
- patient's satisfaction(24 months)
- patient's discomfort(24 months)
研究者
Mariana Minatel Braga
PhD, Associate Professor
University of Sao Paulo