Xylitol for Caries Prevention in Inner-City Children

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

562 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Xylitol GB

Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant

Group Type EXPERIMENTAL

Xylitol gummy bears

Intervention Type DIETARY_SUPPLEMENT

The children receive xylitol gummy bears 3 times/day within the supervised school environment.

Oral health education

Intervention Type BEHAVIORAL

Oral health education, toothbrush, and fluoride toothpaste

Fluoride varnish

Intervention Type DEVICE

The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.

Dental sealant

Intervention Type DEVICE

The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted.

Fiber GB

Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant

Group Type PLACEBO_COMPARATOR

Sugar free fiber gummy bears

Intervention Type DIETARY_SUPPLEMENT

The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.

Oral health education

Intervention Type BEHAVIORAL

Oral health education, toothbrush, and fluoride toothpaste

Fluoride varnish

Intervention Type DEVICE

The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.

Dental sealant

Intervention Type DEVICE

The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted.

Interventions

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Xylitol gummy bears

The children receive xylitol gummy bears 3 times/day within the supervised school environment.

Intervention Type DIETARY_SUPPLEMENT

Sugar free fiber gummy bears

The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.

Intervention Type DIETARY_SUPPLEMENT

Oral health education

Oral health education, toothbrush, and fluoride toothpaste

Intervention Type BEHAVIORAL

Fluoride varnish

The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.

Intervention Type DEVICE

Dental sealant

The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted.

Intervention Type DEVICE

Other Intervention Names

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Cavity Shield UltraSeal XT plus

Eligibility Criteria

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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)

Minimum Eligible Age

5 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No