Xylitol for Caries Prevention in Inner-City Children

Dental Caries Clinical Trial

Official title:

Xylitol for Caries Prevention in Inner-City Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901250
• Other study ID #: 11-06-18
• Secondary ID: R40MC07838
• Status: Completed
• Phase: N/A
• First received: July 12, 2013
• Last updated: July 22, 2014
• Start date: August 2007
• Est. completion date: December 2011

Study information

• Verified date: July 2014
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 562
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 6 Years

Eligibility

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)

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

Intervention

Dietary Supplement:
• Xylitol gummy bears
The children receive xylitol gummy bears 3 times/day within the supervised school environment.
• 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.
• Dental sealant
The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted.

Locations

Country	Name	City	State
United States	Case Western Reserve University	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Case Western Reserve University	Health Resources and Services Administration (HRSA), University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (3)

Nelson S, Eggertsson H, Powell B, Mandelaris J, Ntragatakis M, Richardson T, Ferretti G. Dental examiners consistency in applying the ICDAS criteria for a caries prevention community trial. Community Dent Health. 2011 Sep;28(3):238-42. — View Citation

Nelson S, Mandelaris J, Ferretti G, Heima M, Spiekerman C, Milgrom P. School screening and parental reminders in increasing dental care for children in need: a retrospective cohort study. J Public Health Dent. 2012 Winter;72(1):45-52. doi: 10.1111/j.1752-7325.2011.00282.x. Epub 2011 Oct 10. — View Citation

Nelson S, Milgrom P. Minority participation in a school-based randomized clinical trial of tooth decay prevention in the United States. Contemp Clin Trials. 2012 Jan;33(1):60-6. doi: 10.1016/j.cct.2011.09.012. Epub 2011 Oct 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Number of Decayed or Filled Permanent Teeth (DFT) From Baseline (Beginning of Kindergarten) to the Middle of 2nd Grade	The primary outcome measure was change in the number of decayed or filled permanent teeth (DFT). Caries was assessed in accordance to the International Caries Detection and Assessment System (ICDAS). The ICDAS criteria record both the severity and activity of the lesion on occlusal surfaces, in pit and fissure sites on the buccal and lingual surfaces, and on other smooth surfaces.; For the purposes of this study, an ICDAS severity score of 3 to 6 and the presence of fillings constituted the "D" and "F" portions of DFT, respectively.	baseline and middle of 2nd grade	No