Prevention of Dental Caries in Primary Molars on Sealants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- decayed tooth surfaces
研究概览
简要总结
Currently, the real scope of sealants (AS) is poorly documented in temporary dentition and its effectiveness has not been demonstrated. Yet it seems reasonable that the AS in temporary dentition could slow the specific development of carious lesions in early childhood. In addition, this non-invasive approach could delay the conventional food and thus save financial costs for more complex treatments. Finally, the installation of AS could afford, as demonstrated in adult teeth, lowering the cariogenic bacteria prevalence engaged in the caries process.
详细描述
Currently, the real scope of sealants (AS) is poorly documented in temporary dentition and its effectiveness has not been demonstrated. Yet it seems reasonable that the AS in temporary dentition could slow the specific development of carious lesions in early childhood. In addition, this non-invasive approach could delay the conventional food and thus save financial costs for more complex treatments. Finally, the installation of AS could afford, as demonstrated in adult teeth, lowering the cariogenic bacteria prevalence engaged in the caries process.
Main objective: To evaluate the effect of AS on caries incidence in the deciduous dentition obtained over a period of three years, taking into account the risk of caries established initially.
Secondary objectives:
- To assess the prevalence and caries attack sites at the end of each year
- Estimate the retention rate (partial or complete) of the AS during the study
- Determine the cost savings of treatment during the trial period
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
test and control tooth groups. Each patient is therefore his own witness
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who have at least two pairs (test / control) of healthy molars with occlusal surface or non cavitary initial injury.
- •Children available for a follow-up 3 years
- •Children being affiliated or beneficiary in a health insurance plan
排除标准
- •Children involved in other research in the same field
- •Child is exclusion period determined by previous research
- •Children participating in research in the last three months its inclusion
- •Parents do not understand French.
- •Children deprived of liberty.
- •Child participation Refusal
- •Refusal to participate in either of the parents or legal representative
结局指标
主要结局
decayed tooth surfaces
时间窗: 1 year
The main variable is the number of new decayed tooth surfaces between the end and the beginning of the research. The caries experience will also be evaluated and expressed by the index 'dmfs' (accumulation of decayed tooth surfaces over those missing or filled due to caries). The secondary variable will be the expression of the retention of AS. The comparison of caries incidence between the two groups of teeth (with and without AS) will take into account the membership of the teeth to the same subject by means of the statistical test Chi-McNemar two. Regression models logistics and Poisson regression will be used to test the effect of independent variables on the appearance of new cavities. The Stata statistical software will be used.
次要结局
- decayed tooth surfaces(3years)