Maternal Consumption of Xylitol to Reduce Early Childhood Decay (MaXED Study)
试验速览
- 阶段
- 不适用
- 发起方
- NHS Fife
- 入组人数
- 1,064
- 试验地点
- 2
- 主要终点
- Caries occurrence at the age 3 and 5 yrs;
研究概览
简要总结
The purpose of this study is to determine if the Childsmile programme (www.child-smile.org) with the additional maternal use of xylitol is more effective at reducing dental decay in children than a Childsmile program alone.
The children will be compared in the two groups at age two, to determine how the interventions affected the early colonization of mutans streptococci, an important risk factor of tooth decay.
At three and at five years the investigators will also examine the amount of tooth decay in these children.
Using MIDAS (Scotland's national health service dental data) records, the investigators will follow the oral health of the children until the age of 5 years.
Main hypothesis:
The maternal consumption of xylitol reduces early childhood caries
详细描述
Xylitol has been shown to decrease mutans streptococci transmission between mother and child. Such maternal consumption of xylitol studies have, however not been tested in a Scottish population.
Sign 83, (www.sign.ac.uk/pdf/sign83.pdf) a Scottish government publication states that carrying out research in this area is needed.
Childsmile (www.child-smile.org) is a Scottish government programme that promotes oral health from birth, particularly amongst people living in priority areas.
Parents of newborn children who are assessed to be at risk of developing tooth decay are referred to the programme by their Health Visitor. Parents are visited at home by a Dental Health Support Worker. The dental health support worker will give more information, advice and arrange regular visits for participants to their local Dental Practice.
This research study will compare two groups; one group randomised into the childsmile preventative programme, the other group randomised into the childsmile preventative programme plus consuming 5 grams of xylitol per day.
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
- Single (Investigator)
入排标准
- 年龄范围
- 2 Weeks 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mother with high counts of MS (MS equal or higher than log 5)
- •Child less than 3 months of age
- •Has a close relationship with Fife (e.g. lives or works in Fife)
- •Child seen by health visitor
- •Mother who is the main carer of her children
排除标准
- •Mother with low or no MS
- •Child older than 3 months of age
- •Child not seen by health visitor
- •No close relationship with Fife (e.g. doesn't live or work in Fife)
- •Mother who is not the main carer of her children
结局指标
主要结局
Caries occurrence at the age 3 and 5 yrs;
时间窗: 5 years
Oral microbial colonization at 2 yrs
时间窗: 2 years
次要结局
- To determine the compliance and acceptability of xylitol consumption by the mother • Acceptability by the mother (as measured qualitatively using periodic questionnaires)(2 years)