Xylitol for Caries Prevention in Inner-City Children
关键词
抽象
描述
This is a two group, 30 month randomized controlled clinical trial to assess, in conjunction with other primary preventive modalities, the use of xylitol gummy bears as snack food during school hours to reduce dental caries among children attending Kindergarten at the time of recruitment.
Classrooms in five elementary schools were randomized to receive xylitol gummy bears or the control sugar-free (fiber) gummy bears. All gummy bears were formulated to be similar in size, consistency, color, and sweetness. They were in six bright colors attractive to children, and in strawberry and cherry flavors which are popular among children. Children were encouraged to chew the gummy bears slowly to maximize the xylitol exposure time in the mouth. The children received xylitol or placebo gummy bears throughout the 9 month kindergarten year, 3 times/day within the supervised school environment.
In addition to gummy bears, all participating children received oral health education, tooth brushing and fluoridated toothpaste, topical fluoride varnish treatment, and dental sealants when the first permanent molars have completely erupted. This design allows for the comparison between the current best recommended public heath practices and the addition of the new strategy, xylitol gummy bear snacks. Children were enrolled in kindergarten and followed until the middle of 2nd grade.
日期
最后验证: | 06/30/2014 |
首次提交: | 07/11/2013 |
提交的预估入学人数: | 07/14/2013 |
首次发布: | 07/16/2013 |
上次提交的更新: | 07/21/2014 |
最近更新发布: | 08/11/2014 |
首次提交结果的日期: | 07/21/2014 |
首次提交质量检查结果的日期: | 07/21/2014 |
首次发布结果的日期: | 08/11/2014 |
实际学习开始日期: | 07/31/2007 |
预计主要完成日期: | 11/30/2011 |
预计完成日期: | 11/30/2011 |
状况或疾病
干预/治疗
Dietary Supplement: Xylitol GB
Dietary Supplement: Fiber GB
Behavioral: Oral health education
Device: Fluoride varnish
Device: Dental sealant
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: Xylitol GB Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant | Dietary Supplement: Xylitol GB The children receive xylitol gummy bears 3 times/day within the supervised school environment. |
Placebo Comparator: Fiber GB Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant | Dietary Supplement: Fiber GB The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment. |
资格标准
有资格学习的年龄 | 5 Years 至 5 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - attending kindergarten in one of the participating schools - must have parental permission Exclusion Criteria: - children with severe stomach illness (ex. Crohn's disease, ulcerative colitis, Celiac disease, irritable bowel syndrome, etc.) - children with strict dietary restriction (ex. Diabetes) |
结果
主要结果指标
1. Change in the Number of Decayed or Filled Permanent Teeth (DFT) From Baseline (Beginning of Kindergarten) to the Middle of 2nd Grade [baseline and middle of 2nd grade]