Effect of 12 Months Supplementation With a Symbiotic Lozenge on Caries Increment in Healthy Children: A Randomized, Parallel-grouped, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 343
- 试验地点
- 1
- 主要终点
- Increase in caries incidence
研究概览
简要总结
The primary objective of this trial is to investigate the effect of a symbiotic lozenge on dental caries in young children.
详细描述
The study is a multicentre, randomized, double-blind, placebo-controlled, parallel-group study in healthy children aged 5-8 years. The objective is to investigate the effect of a symbiotic lozenge on caries increment in primary molar teeth, primary canines and erupted occlusal surfaces at the first permanent molar teeth.The study will take place in Helsingør and Fredensborg municipality.
The study consists of a baseline visit prior to a 12 months intervention period, followed by a visit after completion. During the intervention period, two to four months after the baseline visit, a saliva sample will be collected.
All guardians to the subjects are encouraged to 1) brush their children's teeth twice daily with the fluoride toothpaste provided, 2) avoid the food provided in appendix D and 3) to continue the subject's dental appointments at local Public Dental Health Service (PDHS). No further specific oral hygiene or dietary instructions/restrictions are provided.
Assuming a dropout rate of 12.5%, 175 children will be included in each treatment group.
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)
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children with absence of severe chronic disease
- •Age 5-8 years, both inclusive, at inclusion
- •Ability to cooperate at dental examination
- •Ability to cooperate to a daily intake of a lozenge
- •Parents/legal guarding provided voluntary written informed consent
排除标准
- •Children with severe medical conditions
- •Mentally or physically disabled children
- •Children of parents with language barriers and not able to give written informed consent
研究组 & 干预措施
Active
A lozenge containing 2 billion CFU in total of the two strains Lactobacillus paracasei subsp. paracasei and Lactobacillus rhamnosus and arginine 2% to be taken once daily
干预措施: 2 billion CFU in total of the two strains Lactobacillus paracasei subsp. paracasei and Lactobacillus rhamnosus and arginine. (Dietary Supplement)
Placebo
An identical lozenge except for the absence of probiotics and arginine to be taken once daily.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Increase in caries incidence
时间窗: 12 months
Caries increment in primary molar teeth, primary canines and erupted occlusal surfaces at the first permanent molar teeth in children aged 5-8 years, using a modified dmf-s scale, including the occlusal surfaces of the first permanent teeth where d is defined by ICDAS scale and assessed both clinically and by dental x-ray.
次要结局
未报告次要终点