A Tele-detection and Referral pAthways Model for Early Childhood cariEs Control- a Randomized Factorial Study: The TRACE Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- The percentage of teeth receiving care
研究概览
简要总结
The aim of the study is to assess the effectiveness of ECC tele-detection methods combined with referral pathways, with and without user fee removal, in controlling ECC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age <6 years old with primary dentition only.
- •Written consent from the legal guardian
排除标准
- •Children above 6 years old.
- •Children with mixed or permanent dentitions.
- •Children with physical disabilities or psychiatric disorders.
- •Children with intellectual disabilities.
- •Children indicated for dental treatment under general anesthesia
结局指标
主要结局
The percentage of teeth receiving care
时间窗: up to 12 months
This will be assessed using the Caries Assessment Spectrum and Treatment (CAST) index. The CAST index hierarchically describes the full spectrum of caries from the absence of caries, passing through prevention (sealants) and treatment (restoration), to the presence of carious lesions with their complications (pulp exposure, abscess/fistula, and tooth loss). As for the condition severity, Codes 0-2 represent "healthy", 3 indicates "pre-morbidity", while 4-5 indicate "morbidity", 6-7 indicate "serious morbidity", and 8 indicates "mortality".
次要结局
- The child's behavior during dental photography(throughout the procedure completion)
- Oral health-related quality of life(up to 12 months)
- Procedure time(throughout the procedure completion)
- The child's mood during dental photography(throughout the procedure completion)
- Percentage of preventive visits completed per child(up to 12 months)
- Rate of treatment completion(up to 12 months)
研究者
Nourhan M.Aly
Assistant Lecturer of Dental Public Health
University of Alexandria