CARies DEtection in Children-Pelotas (CARDEC-PEL): Comparison of Two Methods of Caries Risk Assessment in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- New caries lesions
研究概览
简要总结
The aim of the study was to compare dental caries treatment and follow-up based on an elaborate and individualized assessment of caries risk in children, to a simpler risk assessment strategy by means of a double-blind randomized clinical trial of two years monitoring. Participants will be children from 7 to 11 years old, who pass through the screening of the Children's Clinic of the Faculty of Dentistry of the Federal University of Pelotas and fulfill the inclusion criteria. A randomized, stratified sample of approximately 250 children will be included in the study, one group will be composed of children undergoing dental caries-related treatment and maintenance, guided by an individualized and multivariate risk assessment, and another group of children treated based on dental caries experience alone in the deciduous and / or permanent dentition. Recruitment will begin at the beginning of 2019, and participants will be followed up for 24 months. Parents will respond to an anamnesis, 24-hour dietary recall, food frequency questionnaire, and oral and general health-related quality of life questionnaire, children will undergo a clinical examination to assess caries, according to the International Caries Detection and Assessment System (ICDAS) in its simplified form and evaluation of caries activity. Dental treatments and return intervals will be designated according to the individual risk of the patient detected in the initial approach according to the group. The study evaluations consist of baseline, 12 months and 24 months, data will be transferred to spreadsheets after the different phases of the study. Primary outcomes (number of dental surfaces requiring operative intervention) and secondary outcomes will be analyzed by Student's t test, quality of life and quality of life related to oral health, will be assessed at the beginning of the study and at the end of treatment, and compared between the groups.
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)
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 7 years months to 11 years;
- •Children seeking dental treatment at the Pediatric dentistry university clinic in Pelotas (UFPel)
排除标准
- •Medical and/or behavioral conditions that requires special considerations regarding management/treatment of the child
结局指标
主要结局
New caries lesions
时间窗: from baseline (first measurement) to 24months
Incremental number of dental surfaces with operative treatment needs. 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 treatment plan.
次要结局
- Quality of life score(from baseline (first measurement) to 24months)
研究者
Maximiliano Sergio Cenci
Principal Investigator
Federal University of Pelotas