Xylitol for Caries Prevention in Inner-City Children

Not Applicable

Completed

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

Brief 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.

Detailed 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 & Eligibility

Inclusion Criteria

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)

Arm && Interventions

Group	Intervention	Description
Xylitol GB	Dental sealant	Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant
Fiber GB	Sugar free fiber gummy bears	Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant
Fiber GB	Dental sealant	Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant
Xylitol GB	Oral health education	Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant
Fiber GB	Fluoride varnish	Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant
Xylitol GB	Fluoride varnish	Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant
Xylitol GB	Xylitol gummy bears	Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant
Fiber GB	Oral health education	Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant

Primary Outcome Measures

Name	Time	Method
Change in the Number of Decayed or Filled Permanent Teeth (DFT) From Baseline (Beginning of Kindergarten) to the Middle of 2nd Grade	baseline and 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.

Secondary Outcome Measures