Fluoride Varnish in the Prevention of Dental Caries in Aboriginal and Non-aboriginal Children
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|ClinicalTrials.gov Identifier: NCT00435500|
Recruitment Status : Unknown
Verified August 2009 by University of Toronto.
Recruitment status was: Active, not recruiting
First Posted : February 15, 2007
Last Update Posted : August 25, 2009
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries||Drug: Fluoride varnish||Phase 3|
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 oral health disparities between native and non-native children. ECC negatively impacts on the quality of life of children suffering from the disease and the caregivers and family members who care for them. To address the problem of ECC, a range of health promotion campaigns, including parent education aimed at balancing the knowledge and values of First Nations communities with the recommendations of the scientific community, have been implemented but these initiatives have had limited success in reducing the impact of ECC and its treatment.
While oral health promotion campaigns have raised awareness of the severity of ECC among these communities, the literature shows that for this age cohort, increasing host resistance through professionally applied topical fluoride (PATF) applications at regular intervals may achieve better results. Of all the PATF methods, slow-release fluoride varnish may be the most practical alternative to the use of gels, foams and rinses, as it decreases the risk of fluoride ingestion and is associated with greater patient acceptability. Fluoride varnish has shown promise as a caries reduction agent but more evidence for the effectiveness of this intervention is needed, particularly for high-caries-risk populations like those in Aboriginal communities.
The aim of this study is to determine the effectiveness of fluoride varnish (Duraflor, 5% NaF, Pharmascience) combined with caregiver counseling in preventing and reducing ECC in Aboriginal communities, in a 2-year randomized controlled trial. Methods: The trial enrolled 1226 children aged 6 months to 5 years from the Sioux Lookout Zone (SLZ) First Nations reserves and 149 from Thunder Bay (NW Ontario). Twenty First Nations communities were randomized to 2 study groups; families in both groups received oral health counseling and restorative dental care provided by the SLZ Dental Program - one group received no fluoride varnish (FV0) and the other received FV 2-3×/yr. The same subjects were examined for the dmft/s indices by trained and calibrated dental hygienists in 2003, 2004 and 2005. A caregiver questionnaire assessed the impact of ECC on the quality of life of the child and the family. The SLZ Hospital provided data on children's dental general anesthetic (GA) procedures. Comparative cross-sectional oral health data for 416 (2003), 687 (2004) and 544 (2005) 3-5 yr-olds attending Junior Kindergarten in Thunder Bay, not receiving fluoride treatments, were collected by the Thunder Bay District Health Unit's dental hygienists and recorders. Results will assist decision makers in developing programs for addressing the problem of ECC in high-caries-risk populations.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1320 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Fluoride Varnish in the Prevention of Dental Caries in Aboriginal and Non-aboriginal Children|
|Study Start Date :||June 2003|
|Study Completion Date :||January 2006|
- Reduction in the 2-year caries increment (dmfs/DMFS index); final follow-up at 24 months.
- (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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00435500
|Sioux Lookout Zone Dental Program|
|Sioux Lookout, Ontario, Canada, P8T 1C2|
|Principal Investigator:||Herenia P. Lawrence, DDS, PhD||University of Toronto, Faculty of Dentistry, Toronto, Ontario, Canada|