Effectiveness of the International Caries Classification and Management System (ICCMS) in Reducing the Incidence of Dental Caries in Children Attending to the CURUMIM Social Project, Sesc/São Paulo(SP)
试验速览
- 阶段
- 不适用
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Incidence of caries
研究概览
简要总结
The aim of the present study is to evaluate the effectiveness of using the ICCMS (International Caries Classification And Management System)in reducing caries lesions incidence compared to a control group that use different criteria as a not systematic and standardized prevention strategy. The study will be performed among children attending to the social project of Social Service of Commerce (SESC), Sao Paulo. The sample will be composed of 460 children aging between 7 to 12 years old registered in CURUMIM Program from eight dental centers of SESC. A randomized controlled study with parallel group will be conducted. The centers will be randomized between the 2 strategies, defining 2 groups with 4 centers each. The experimental group that will follow the criteria defined by the ICCMS will evaluate clinical and behavioral variables, it will define: evaluation of the caries risk of the patient, evaluation of the intraoral risk, diagnosis of the caries lesion and its respective activity, plan decision individualized treatment for the patient and indication of recall interval according to the risk of caries. In the control group, children need will be solved according to rthe routinely dental practices in the center, but the determination of the child's general and intraoral risk of developing new caries lesions will not be performed nor the scheduling of specific recall intervals according to the risk.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The division of the control and experimental groups was done by center and for neither group are revealed to the patient nor responsible for the type of intervention they are undergoing.
After a certain time of the study, a blind investor will examine the children's centers and evaluate the outcome of the study. This researcher will not know which center is a control or experimental group.
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children who participate in the CURUMIM Program
- •Children whose parents sign the term of informed consent confirming their participation.
排除标准
- •Children with cognitive impairment, motor impairment and feeding tube.
研究组 & 干预措施
Test - ICCMS
The dentists will perform clinical examination on children following the ICCMS sequence:
The patient's caries risk assessment, Diagnosis of caries lesion and activity assessment Intraoral risk assessment, Decide on a personalized care plan for patient and clinical interventions.After asses all the factors and defining the patient's individual risk, the system presents a personalized treatment plan, indicating the appropriate home care instructions, clinical interventions and specific treatment for each caries lesion categories.
The return intervals will be scheduled according to the risk: low risk (return of 1 year), moderate risk (6 months) and high risk (3 months)
干预措施: ICCMS (Other)
Control - Standard care SESC
The clinical sequence in this group will be:
Caries Diagnosis Operative and non-operative treatments Indication of recall interval according to the dentist However, dentists will do that without a schematic guide to follow. They will do as they usually do in their practices.
干预措施: SESC standard care (Other)
结局指标
主要结局
Incidence of caries
时间窗: 2 years
New cavitated caries lesions
Cost-effectiveness
时间窗: 2 years
Ratio between the difference in costs and in effects regarding the programs
次要结局
- New initial caries lesions(2 years)
- Qualitative measurement of difficulties and issues during the programs implementation(2 years)
- Oral Health-Related Quality of Life (OHRQoL)(2 years)
研究者
Mariana Minatel Braga
Professor
University of Sao Paulo