Status:
UNKNOWN
Fluoride Varnish in the Prevention of Dental Caries in Aboriginal and Non-aboriginal Children
Lead Sponsor:
University of Toronto
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
The Hospital for Sick Children
Conditions:
Dental Caries
Eligibility:
All Genders
6-71 years
Phase:
PHASE3
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, k...
Detailed Description
Early childhood caries (ECC) is by far the most common chronic disease among Canadian Aboriginal children, affecting nearly 90% of First Nations preschoolers in Ontario. It is the number one cause of ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
1320 Patients enrolled
Trial Details
Trial ID
NCT00435500
Start Date
June 1 2003
End Date
January 1 2006
Last Update
August 25 2009
Active Locations (1)
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1
Sioux Lookout Zone Dental Program
Sioux Lookout, Ontario, Canada, P8T 1C2