MedTrace Logo

Xylitol for Caries Prevention in Inner-City Children

NCT01901250 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 562

Last updated 2014-08-12

Study results available
· View outcomes & findings →

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.

Conditions

  • Dental Caries

Interventions

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.

Sponsors & Collaborators

  • Health Resources and Services Administration (HRSA)

    collaborator FED

  • University of Washington

    collaborator OTHER

  • Case Western Reserve University

    lead OTHER

Principal Investigators

  • Suchitra Nelson, PhD · Case Western Reserve University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01901250 on ClinicalTrials.gov