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Fluoride Varnish in Aboriginal and Non-aboriginal Children
NCT00435500Phase 3
Key facts
- Status
- Unknown
- Start
- Jun 2003
- Countries
- 1
- Sponsor
- University of Toronto
- Modality
- DNA Intercalators/Alkylators
- Drugs
- sodium fluoride
- Conditions
- dental caries
01
Overview
Phase 3, randomised, open-label trial of sodium fluoride in dental caries (2 arms), sponsored by University of Toronto. Primary endpoint: Reduction in the 2-year caries increment (dmfs/DMFS index). Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
Fluoride Varnish
Fluoride varnish (Duraflor, 5% NaF) applied 2-3 times per year + Caregiver Counseling.
No Fluoride Varnish
No fluoride varnish application + Caregiver Counseling.
03
Who it enrols
Children aged 6 months to <6 years with at least one primary tooth, residing in First Nations Communities in Sioux Lookout Zone or Thunder Bay District Area. Excludes children with ulcerative gingivitis, stomatitis, or allergy to colophony.
04
Endpoints
Primary
Reduction in the 2-year caries increment (dmfs/DMFS index)
Secondary
Need for dental treatment under general anaesthesia
Score on an oral-health-related quality of life scale
Annualized cost of fluoride varnish treatment per child
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