Xylitol for Caries Prevention in Inner-City Children

Case Western Reserve University

Status: Completed

Conditions: Dental Caries

Treatments: Device: Dental sealant; Dietary Supplement: Xylitol gummy bears; Behavioral: Oral health education; Device: Fluoride varnish; Dietary Supplement: Sugar free fiber gummy bears

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01901250

11-06-18

R40MC07838 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 562 patients

Sex: All

Ages: 5 to 6 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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562 participants in 2 patient groups, including a placebo group

Xylitol GB

Experimental group

Description:

Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant

Treatment:

Dietary Supplement: Xylitol gummy bears

Device: Fluoride varnish

Behavioral: Oral health education

Device: Dental sealant

Fiber GB

Placebo Comparator group

Description:

Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant

Treatment:

Dietary Supplement: Sugar free fiber gummy bears

Device: Fluoride varnish

Behavioral: Oral health education

Device: Dental sealant