Evaluation of Caries Prevention Based on Genetic Etiology and Risk: Protocol for a Multicenter Randomized Controlled and Adaptive Trial for Oral Personalized Care (PRECARIES)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 520
- 试验地点
- 2
- 主要终点
- % change in increment DeFS (decayed, enamel included and filled tooth surfaces)
研究概览
简要总结
Dental caries affects billions of people worldwide and involves saliva immunodeficiency, commensal pathogen and exposure (lifestyle) causal subtypes of the disease. Up to 85% of adolescents in Swedish and other low prevalence populations are caries-free while the remaining 15% show high, recurrent caries activity. Accordingly, there is a lack of cost-effective risk assessment and prevention tools for personalized oral care. This randomized adaptive clinical trial (RCT) evaluates both caries prevention based on genetic etiology and risk, as a consequence of saliva immunodeficiency genes specifying individuals as susceptible or resistant to caries, and the effect of intensified versus selfcare traditional prevention on the two groups.
详细描述
This is a protocol for a multicenter risk assessment and intervention study (PRECARIES) with an adaptive component. The study design comprises a prescreen of 2000 adolescents of which 520 will be included in the RCT study part with adolescents undergoing ordinary orthodontic treatment with multibrackets at the Public Dental Service. The orthodontic treatment allows for rapid caries development and improved discrimination between susceptible versus resistant individuals. The children are genotyped into two risk groups; genetic susceptible and non-susceptible children that are assigned to intensive or traditional standard prevention. The clinical outcomes will adaptively be measured at different time points (0, 6, 12 and months) as caries lesions at different teeth and surfaces using tactile, visual and X-ray bitewing, clinical photos and quantitative laser fluorescence (QLF). Secondary outcomes will be inflammation at the gingival margins and pocket depth at debonding of the orthodontic appliances. Questionaires are collected as well as biological samples; swab-dna, whole and parotid saliva and microbiota. Human and microbiota geno-and protein typing involves in and ex house platforms adaptively.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participant is not informed about if they are in the control or intervention group Outcome assessor are not aware of group allocation Both dentist/nurse and patient do not know the genotype or risk group. Caries registration at start and end will be performed by a dentist not involved in giving the orthodontic treatment or prevention to each patient
入排标准
- 年龄范围
- 13 Years 至 23 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing orthodontic treatment with fixed multibrackets appliance in the upper and lower arch
排除标准
- •impacted canines
- •agenesis in the frontal region
- •maxillofacial surgery
结局指标
主要结局
% change in increment DeFS (decayed, enamel included and filled tooth surfaces)
时间窗: 24 months
The % change in ΔDeFS caries increment over a follow up period of 6 and 24 months related to prevention.
DFS (decayed and filled tooth surfaces) and DeFS (decayed, enamel included and filled tooth surfaces)
时间窗: 24 months
The baseline and prospective caries scores for incidence and progression of lesions related to risk group
次要结局
- Gingival inflammation(24 months)
- Mineralization disorders(24 months)