Effect of Probiotic Lactobacillus Salivarius and Cranberry on Oral Health of Children
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Changing the titre of the carcinogenic bacteria Streptococcus mutans
研究概览
简要总结
The aim of the randomized, double-blind clinical trial with placebo is to answer the clinical question , or in children with diagnosed childhood early caries the use of L.salivarius and cranberry contained in NutroPharma lozenges will reduce new carious lesions and reduce the titre of the carcinogenic bacteria Streptococcus mutans, compared to the control group in which the placebo will be administered? The main end point will be to reduce the titre of cariogenic bacteria.
详细描述
Probiotic bacteria are used in the prevention and treatment of gastrointestinal diseases and infections, including the treatment of oral diseases. Probiotic bacteria can be found in saliva, plaque and adhering directly to the mucous membrane. They compete with cariogenic bacteria and pathogens of periodontal disease. Increased interest in probiotics means that attempts are being made to find new solutions regarding the methods of their administration. The use of probiotic bacteria brings beneficial health effects. Lactobacillus salivarius is a strain isolated from human milk. It is inactive (heat treatment) and therefore does not produce metabolites that can promote the formation of carious lesions in the mouth by lowering the mouth potential of hydrogen.
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
- Triple (Participant, Care Provider, 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
- •colony forming unit 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,
- •colony forming unit 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
Participants will receive two lozenges containing probiotic bacteria and cranberry.
干预措施: Probiotics (Dietary Supplement)
Placebo - No probiotics
Participants will receive a control two lozenges containing no probiotic bacteria.
干预措施: Placebo - No probiotics (Dietary Supplement)
结局指标
主要结局
Changing the titre of the carcinogenic bacteria Streptococcus mutans
时间窗: 8 weeks
During control tests saliva will be applied to the medium for identification and detailed quantification of S. 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.
次要结局
未报告次要终点