Xylitol for Caries Prevention in Inner-City Children

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Dental Caries

Clinical Trial Details

NCT number	NCT01901250
Study type	Interventional
Source	Case Western Reserve University
Contact
Status	Completed
Phase	N/A
Start date	August 2007
Completion date	December 2011

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04127929` - Investigation of Glass Carbomer Performance	N/A
Completed	`NCT04769882` - Er:YAG Laser Effects on Microbial Population in Conservative Dentistry	N/A
Completed	`NCT04971317` - The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages	N/A
Active, not recruiting	`NCT04475679` - Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy	N/A
Completed	`NCT05438381` - Comparison of Clinical and Radiographic Outcomes of SMART Technique vs ART in Primary Molars	N/A
Not yet recruiting	`NCT03037814` - Clinical Performance of Restorative Materials in Primary Teeth	N/A
Active, not recruiting	`NCT05202665` - Resin Infiltration and Fluoride Varnish Lesion Arresting Efficacy on Non-cavitated Proximal Lesion	N/A
Terminated	`NCT01147835` - Herbal Lollipops on Oral Bacterial Levels and DMFT/Dmft Scores of Children With Asthma Using Inhalers	N/A
Not yet recruiting	`NCT04033263` - Maintaining Oral Health With Bio-products	N/A
Enrolling by invitation	`NCT04438252` - Evaluation of Reliability of CarieScan PRO Compared With Digital Radiograph and ICDAS-II in Detection of Carious Lesions	N/A
Not yet recruiting	`NCT03609034` - Knowledge, Attitude and Practice of a Group of Egyptian Dental Interns Toward Caries Risk Assessment
Completed	`NCT02912000` - TEACH: Technology Evaluation to Address Child Health	N/A
Completed	`NCT02473107` - Impact of Detecting Initial and Active Caries Lesions in Primary Teeth	N/A
Active, not recruiting	`NCT02537184` - Impact of Two Recall Intervals on Dental Caries Incidence and Other Outcomes of Preschool Children	N/A
Completed	`NCT01950546` - Nanosilver Fluoride to Prevent Dental Biofilms Growth	Phase 1
Recruiting	`NCT02734420` - Effect of Photodynamic Therapy With Low-level Laser on Infected Dentin in Primary Teeth: A Controlled Clinical Trial	Phase 1
Completed	`NCT02020681` - Effect of Curodont Repair or Placebo on the Remineralisation in Patients With Class 5 Carious Lesions	N/A
Completed	`NCT02234609` - Effectiveness of Modified Class IV Atraumatic Restorative Treatment	N/A
Completed	`NCT02426619` - Arresting Active Dental Caries in Preschool Children by Topical Fluorides	Phase 2/Phase 3
Withdrawn	`NCT01224002` - A Comparative Feasibility Study to Assess the Prevalence and Severity of Dental Caries in Incarcerated People Who Abuse Methamphetamine	N/A