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Xylitol for Caries Prevention in Inner-City Children

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赞助商
Case Western Reserve University
合作者
Health Resources and Services Administration (HRSA)
University of Washington

关键词

抽象

The purposes of this study is to determine whether xylitol use in kindergarten school children in addition to oral health education, provision of tooth brush and fluoride paste, fluoride varnish and sealant treatment will reduce decay in the first permanent molars and other permanent teeth.

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

Dental Caries

干预/治疗

Dietary Supplement: Xylitol GB

Dietary Supplement: Fiber GB

Behavioral: Oral health education

Device: Fluoride varnish

Device: Dental sealant

-

手臂组

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
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]

The primary outcome measure was change in the number of decayed or filled permanent teeth (DFT). Caries was assessed in accordance to the International Caries Detection and Assessment System (ICDAS). The ICDAS criteria record both the severity and activity of the lesion on occlusal surfaces, in pit and fissure sites on the buccal and lingual surfaces, and on other smooth surfaces. For the purposes of this study, an ICDAS severity score of 3 to 6 and the presence of fillings constituted the "D" and "F" portions of DFT, respectively.

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