Xylitol for Caries Prevention in Inner-City Children
2 other identifiers
interventional
562
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 12, 2013
CompletedFirst Posted
Study publicly available on registry
July 17, 2013
CompletedResults Posted
Study results publicly available
August 12, 2014
CompletedAugust 12, 2014
July 1, 2014
4.3 years
July 12, 2013
July 22, 2014
July 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Xylitol GB
EXPERIMENTALXylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant
Fiber GB
PLACEBO COMPARATORSugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant
Interventions
The children receive xylitol gummy bears 3 times/day within the supervised school environment.
The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.
Oral health education, toothbrush, and fluoride toothpaste
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.
The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted.
Eligibility Criteria
You may qualify if:
- attending kindergarten in one of the participating schools
- must have parental permission
You may not qualify if:
- children with severe stomach illness (ex. Crohn's disease, ulcerative colitis, Celiac disease, irritable bowel syndrome, etc.)
- children with strict dietary restriction (ex. Diabetes)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Case Western Reserve Universitylead
- Health Resources and Services Administration (HRSA)collaborator
- University of Washingtoncollaborator
Study Sites (1)
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Related 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.
PMID: 21916361BACKGROUNDNelson 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.
PMID: 21986390BACKGROUNDNelson 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.
PMID: 22316214BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Nearly half the children moved out of the school district by the time of the exit examination, which made the power of the analysis insufficient to detect the difference between two groups.
Results Point of Contact
- Title
- Dr. Suchitra Nelson
- Organization
- Case Western Reserve University
Study Officials
- PRINCIPAL INVESTIGATOR
Suchitra Nelson, PhD
Case Western Reserve University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 12, 2013
First Posted
July 17, 2013
Study Start
August 1, 2007
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
August 12, 2014
Results First Posted
August 12, 2014
Record last verified: 2014-07