Influence of the Probiotic Streptococcus Salivarius K12 on Dental Health in Children With Early Childhood Caries
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changing the amount of carcinogenic bacteria Streptococcus mutans in intervention group based on bacterial test counting number of Colony Forming Units
研究概览
简要总结
The purpose of this study is to determine if probiotic lozenges taken once a day before bedtime for twelve weeks can decrease the numbers of Streptococcus mutans
详细描述
Streptococcus salivarius is one of the commensal bacteria of the mouth and the main component of biofilm. Research indicates that some microorganisms present in plaque, which until recently were considered not to cause caries, including Streptococcus salivarius, present in the supragingival microbiome, can also cause tooth decay.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •generally healthy children aged 3-6;
- •recognized caries of early childhood, dmf> 1,
- •lack of active caries and inflammation of the mouth
- •CFU> 105 / ml Streptococcus mutans
- •a minimum of one-month period from: the last antibiotic therapy, probiotic use, professional fluoride prophylaxis or supervised tooth brushing with fluoride preparations, the use of fluoride toothpaste, not using xylitol, written consent of parents / legal guardians for participation in research.
排除标准
- •chronic diseases and chronically taken medicines in the past,
- •planned change of residence during the year,
- •age below 3 and above 6 years,
- •healthy teeth, dmf = 0,
- •CFU <105 / ml Streptococcus mutans
- •Patient during antibiotic therapy, probiotic use, professional fluoride prophylaxis or supervised tooth brushing with fluoride preparations
- •no toothpaste with fluoride
- •using xylitol
- •lack of written consent of parents / legal guardians for participation in research.
研究组 & 干预措施
Probiotics
A half of the participants will be randomly allocated to the probiotics group. They will receive probiotic lozenge before falling asleep for12 weeks. They will receive hygienic and dietetic instructions. examination will be conducted before study and after 12 weeks.
干预措施: Experimental: Probiotics (Dietary Supplement)
CONTROL
no intervention
干预措施: No intervention (Other)
结局指标
主要结局
Changing the amount of carcinogenic bacteria Streptococcus mutans in intervention group based on bacterial test counting number of Colony Forming Units
时间窗: 12 weeks
During control test saliva will be applied to the medium for identification and detailed quantification of Streptococcus mutans bacteria. After the incubation, the number of bacteria will be expressed - taking into account the degree of saliva dilution - as the number of colony-forming unit (CFU) in 1 ml of saliva. colony forming unit CFU in intervention and control groups. Bacterial tests will be used to assess this outcome measure. We expect decrement of amount of cariogenic bacteria in intervention group
次要结局
未报告次要终点