CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 562 enrolled
Drug / intervention
Xylitol gummy bears +4 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01901250
NCT01901250N/ACompleted

Xylitol for Caries Prevention in Inner-City Children

Case Western Reserve University·interventional·Posted Jul 17, 2013·Updated Aug 12, 2014

In Brief

A clinical study evaluating Xylitol gummy bears, Sugar free fiber gummy bears, and 3 other interventions for Dental Caries. Completed, enrolled 562 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Caries
CountriesUnited States

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 17, 2013
Enrollment StartAug 1, 2007
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 13.0 years ago

Interventions

Xylitol gummy bearsdietary

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

Sugar free fiber gummy bearsdietary

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

Oral health educationbehavioral

Oral health education, toothbrush, and fluoride toothpaste

Fluoride varnishdevice

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 sealantdevice

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