The Effect of the Frequent Xylitol Chewing Gum Use on the Oral Microbiota in Children With High MS Counts
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- MS Counts of Stimulated Saliva
研究概览
简要总结
- The present controlled, randomized, doubleblind study aims to answer the following questions:
- How will the "normal flora" be affected by the xylitol consumption?
- Will daily consumption of xylitol change the plaque-saliva distribution of the mutans streptococci?
- The association of the test results will also be compared with the caries status at the baseline.
- About eighty subjects with MS counts of log CFU 5 or more will be identified and invited to the study. They will be randomly divided into a Xylitol and Sorbitol group.
- Xylitol/Sorbitol gum (6g polyol/day) will be used for 5 weeks. Saliva samples will be collected before and after gum use.
- Studying and quantifying of 16 bacterial species belonging to the normal flora by DNA-DNA hybridizations and Real-time PCR will show how xylitol influenced the oral flora in general.
详细描述
Xylitol, a 5-carbon polyol, has in clinical studies prevented caries occurrence in children and decreased counts of mutans streptococci (MS) and the amount of plaque when used on daily basis. How xylitol influences mutans streptococci is far from clear. Also the effects of xylitol on the normal flora are poorly understood.
The present controlled, randomized, doubleblind study aims to answer the following questions:
- How will the "normal flora" be affected by the xylitol consumption?
- Will daily consumption of xylitol change the plaque-saliva distribution of the mutans streptococci?
- The association of the test results will also be compared with the caries status at the baseline.
After collecting informed consent forms from the parents, about 177 children will be screened for the presence of salivary mutans streptococci (SM) with chairside test, Dentocult SM® Strip mutans (Orion Diagnostica, Finland).
Sorbitol is regarded as an inert polyol. Xylitol/Sorbitol gum (6g polyol/day) will be used for 5 weeks. Saliva samples will be collected before and after gum use. Studying and quantifying of 16 bacterial species belonging to the normal flora by DNA-DNA hybridizations and Real-time PCR will show how xylitol influenced the oral flora in general. Comparison of MS counts in unstimulated vs. stimulated saliva will show how xylitol affected the adhesivity of the MS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 11 Years 至 14 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •high SM count
排除标准
- •low SM count,
- •ongoing medication
结局指标
主要结局
MS Counts of Stimulated Saliva
时间窗: 5 weeks
The MS counts were measured at the beginning and in the end of the 5 weeks intervention
次要结局
- The Changes in the Counts of the 14 Other Bacterial Species(5 weeks)