Fluoride Varnish in the Prevention of Dental Caries in Aboriginal and Non-aboriginal Children (NCT00435500) | Clinical Trial Compass
UnknownPhase 3
Fluoride Varnish in the Prevention of Dental Caries in Aboriginal and Non-aboriginal Children
Canada1,320 participantsStarted 2003-06
Plain-language 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.
Who can participate
Age range6 Months – 71 Months
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Reduction in the 2-year caries increment (dmfs/DMFS index); final follow-up at 24 months.