NCT01901250

Xylitol for Caries Prevention in Inner-City Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 562 (actual)
• Sponsor: Case Western Reserve University · Academic / Other
• Sex: All
• Age: 5 Years – 6 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Dental Caries

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Xylitol gummy bears	The children receive xylitol gummy bears 3 times/day within the supervised school environment.
DIETARY_SUPPLEMENT	Sugar free fiber gummy bears	The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.
BEHAVIORAL	Oral health education	Oral health education, toothbrush, and fluoride toothpaste
DEVICE	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.
DEVICE	Dental sealant	The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted.

Timeline

• Start date: 2007-08-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2013-07-17
• Last updated: 2014-08-12
• Results posted: 2014-08-12

Locations

1 site across 1 country: United States