N/A
N=525
Xylitol for Caries Prevention in Inner-City Children
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT01901250 ↗Enrolled (actual)
525
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Change in the Number of Decayed or Filled Permanent Teeth (DFT) From Baseline (Beginning of Kindergarten) to the Middle of 2nd Grade — 0.38; 0.48 Number of surfaces — p=0.25
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Xylitol gummy bears (Dietary_supplement); Sugar free fiber gummy bears (Dietary_supplement); Oral health education (Behavioral); Fluoride varnish (Device); Dental sealant (Device)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Case Western Reserve University
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Number of Decayed or Filled Permanent Teeth (DFT) From Baseline (Beginning of Kindergarten) to the Middle of 2nd Grade |
0.38; 0.48 | 0.25 |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01901250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.