CARies DEtection in Children - Cost-efficacy, Applicability and Impact on Quality of Life of Detecting Active Initial Caries Lesions in Primary Teeth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Incremental number of dental surfaces with operative treatment needs
研究概览
简要总结
The present study aims to evaluate the impact of detecting active initial caries lesions in primary teeth regarding effectiveness, cost-effectiveness, applicability (acceptability and satisfaction) and quality of life. For this, 248 children 3-6 years with complete primary dentition will be examined and treated in a mobile dental unit, which will temporarily be parked in public schools of Sao Paulo. The caries detection will be conducted using the International Caries Detection and Assessment System (ICDAS) and, depending on allocation, an adjunct criterion for caries activity assessment. Children will be randomized in two groups according to the caries threshold to be detected: Group A (only advanced lesions will be detected and treated, independently of their activity status) and Group B (all caries lesions, including initial ones, will be detected and all active lesions will be treated). After this, the treatment plan for each child will be made according to strategies mentioned above. Data concerning the cost-effectiveness of the procedures, acceptability / satisfaction of children and quality of life will be collected after diagnosis, after the end of treatment and 12 and 24 months from the initial examination. For comparison between groups, multilevel regression analyses will be performed. The primary outcome will be sites which need of operative treatment during the follow-up periods and the secondary outcomes will be the cost-effectiveness of each strategy, the acceptability / satisfaction of the child and the impact on quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 36 Months 至 83 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 36 months to 83 months;
- •Should have complete primary dentition;
- •Children must assent to participate and their parents must consent to their participation by signing the consent form.
排除标准
- •Medical and/or behavioral conditions that requires special considerations regarding management/treatment of the child;
- •Children involved in other research that may impact on this study;
- •Families who are expected to move out of the coverage area of study during the first year of enrollment.
研究组 & 干预措施
Control Caries Detection Strategy
Detection and treatment based on more advanced lesions, despite activity status - Advanced caries lesions detection (no activity assessment)
干预措施: Advanced caries lesions detection (no activity assessment) (Other)
Test Caries Detection Strategy
Detection and treatment based on all detected caries lesions, considering their activity status as a differential in clinical decision-making - All caries lesions detection (+activity assessment)
干预措施: All caries lesions detection (+activity assessment) (Other)
结局指标
主要结局
Incremental number of dental surfaces with operative treatment needs
时间窗: After 12 and 24 months from allocation
This outcome will be assessed by the new caries lesions and / or progression of lesions previously diagnosed / treated and number of treated surfaces which will need restoration replacement, endodontic treatment or extraction after the initial treatment.
次要结局
- Cost-efficacy(After 12 and 24 months from the allocation)
- Discomfort(immediately after the allocation and after 12 and 24 months)
- Impact of oral health on quality of life(12 and 24 months after the allocation)
研究者
Mariana Minatel Braga
PhD, Senior Lecturer
University of Sao Paulo