Overview

Fluoride Varnish in the Prevention of Dental Caries in Aboriginal and Non-aboriginal Children

Status:
Unknown status
Trial end date:
2006-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Toronto
Collaborators:
Canadian Institutes of Health Research (CIHR)
The Hospital for Sick Children
Treatments:
Fluorides
Fluorides, Topical
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.