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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Canadian Institutes of Health Research (CIHR)
The Hospital for Sick Children
Information provided by:
University of Toronto

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, known as early childhood caries, in native and non-native children aged 6 months to 5 years.

Condition or disease Intervention/treatment Phase
Dental Caries Drug: Fluoride varnish Phase 3

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 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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Primary Outcome Measures :
  1. Reduction in the 2-year caries increment (dmfs/DMFS index); final follow-up at 24 months.

Secondary Outcome Measures :
  1. (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Months to 71 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00435500

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Canada, Ontario
Sioux Lookout Zone Dental Program
Sioux Lookout, Ontario, Canada, P8T 1C2
Sponsors and Collaborators
University of Toronto
Canadian Institutes of Health Research (CIHR)
The Hospital for Sick Children
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Principal Investigator: Herenia P. Lawrence, DDS, PhD University of Toronto, Faculty of Dentistry, Toronto, Ontario, Canada
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00435500    
Other Study ID Numbers: MOP-64215
First Posted: February 15, 2007    Key Record Dates
Last Update Posted: August 25, 2009
Last Verified: August 2009
Keywords provided by University of Toronto:
Dental caries, topical fluorides
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs