Xylitol for Caries Prevention in Inner-City Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Xylitol for Caries Prevention in Inner-City Children

Conditions
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Dental Caries

Intervention / Treatment
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* Dietary Supplement: Xylitol gummy bears
* Dietary Supplement: Sugar free fiber gummy bears
* Behavioral: Oral health education
* Device: Fluoride varnish
* Device: Dental sealant


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xylitol GB<br>Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant | Dietary Supplement: Xylitol gummy bears<br>* The children receive xylitol gummy bears 3 times/day within the supervised school environment.<br>Behavioral: Oral health education<br>* Oral health education, toothbrush, and fluoride toothpaste<br>Device: Fluoride varnish<br>* 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.<br>* Other names: Cavity Shield;Device: Dental sealant<br>* The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted.<br>* Other names: UltraSeal XT plus;|
| Placebo Comparator: Fiber GB<br>Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant | Dietary Supplement: Sugar free fiber gummy bears<br>* The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.<br>Behavioral: Oral health education<br>* Oral health education, toothbrush, and fluoride toothpaste<br>Device: Fluoride varnish<br>* 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.<br>* Other names: Cavity Shield;Device: Dental sealant<br>* The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted.<br>* Other names: UltraSeal XT plus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental Caries, Xylitol, Prevention