Fluoride Varnish in the Prevention of Dental Caries in Aboriginal and Non-aboriginal Children
1 other identifier
interventional
1,320
1 country
1
Brief Summary
The purpose of this study is to determine whether semi-annual fluoride varnish applications combined with caregiver counseling are effective in preventing and reducing a severe form of dental decay, known as early childhood caries, in native and non-native children aged 6 months to 5 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2003
Typical duration for phase_3
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
June 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 14, 2007
CompletedFirst Posted
Study publicly available on registry
February 15, 2007
CompletedAugust 25, 2009
August 1, 2009
February 14, 2007
August 21, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in the 2-year caries increment (dmfs/DMFS index); final follow-up at 24 months.
Secondary Outcomes (1)
(1) Need for dental treatment under general anaesthesia at 24 months; (2) score on an oral-health-related quality of life scale at 24 months; (3) the annualized cost of fluoride varnish treatment per child
Interventions
Eligibility Criteria
You may qualify if:
- Children with at least one primary tooth present.
- Age 6 months to \<6 years. Children under 6 months of age may be enrolled in the study if at least one primary tooth has erupted.
- Residing in one of the First Nations Communities in the Sioux Lookout Zone or in the Thunder Bay District Area, both located in Northwestern Ontario, Canada.
- Parental consent must be provided. If the parent is not the primary caregiver, a legal guardian or a family member who is the primary care provider must sign the consent form.
You may not qualify if:
- Children with ulcerative gingivitis and stomatitis. (These children will be referred for treatment.)
- Children with allergy to colophony (colophonium). Colophonium is found in some cosmetics, creams, sunscreens, pine-oil cleaners, chewing gum, and postage stamp glue. Parents will be asked if the child suffers from this particular allergy.
- No teeth present or stainless steel crowns only.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Torontolead
- Canadian Institutes of Health Research (CIHR)collaborator
- The Hospital for Sick Childrencollaborator
Study Sites (1)
Sioux Lookout Zone Dental Program
Sioux Lookout, Ontario, P8T 1C2, Canada
Related Publications (1)
Lawrence HP, Binguis D, Douglas J, McKeown L, Switzer B, Figueiredo R, Laporte A. A 2-year community-randomized controlled trial of fluoride varnish to prevent early childhood caries in Aboriginal children. Community Dent Oral Epidemiol. 2008 Dec;36(6):503-16. doi: 10.1111/j.1600-0528.2008.00427.x. Epub 2008 Apr 14.
PMID: 18422711DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Herenia P. Lawrence, DDS, PhD
University of Toronto, Faculty of Dentistry, Toronto, Ontario, Canada
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 14, 2007
First Posted
February 15, 2007
Study Start
June 1, 2003
Study Completion
January 1, 2006
Last Updated
August 25, 2009
Record last verified: 2009-08