Prevention of Recurrent Childhood Caries With Probiotic Supplement, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 70
- 试验地点
- 6
- 主要终点
- dental caries
研究概览
简要总结
The aim of this study was to compare the effect of drops containing probiotic bacteria (Lactobacillus reuteri 17938, Lactobacillus reuteri PTA 5289, Biogaia AB, Sweden) on the incidence of dental caries with placebo drops in preschool children undergoing comprehensive restorative treatment under general anesthesia or conscious sedation. The project will be conducted at three specialist centers (Umeå University, Umeå, Sweden, Maxillo-facial unit, Halmstad Hospital, Sweden; Eastman Institute, Stockholm, Sweden) and employ a randomized placebo-controlled design with two parallel arms. The study will be performed double-blind and neither the parents nor the clinicians will be aware of the content of the drops. The follow-up period is one year.
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
yellow / blue dots on the bottles indicates different groups
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preschool children, 2-5 year of age
- •with Early childhood caries (ECC) or
- •severe Early childhood caries (S-ECC)
- •scheduled for restorations and extractions under general anesthesia or any form of sedation
- •The obligate requirement is that the child should be fully treated and managed with aspect to caries within a period of not more than two months.
排除标准
- •medically comprised children
- •children with severe cognitive problems or dysfunctional families
- •families planning to relocate within the next year
结局指标
主要结局
dental caries
时间窗: 12 months
dental caries (International Caries Detection and Assesment System, ICDAS level)
次要结局
- visible supra-gingival plaque(12 months)
研究者
Pamela Hasselof
Principal Investigator, senior consultant dentist
Umeå University