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

Primary Purpose

Dental Caries

Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Fluoride varnish
Sponsored by
University of Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring Dental caries, topical fluorides

Eligibility Criteria

6 Months - 71 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sioux Lookout Zone Dental Program

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

(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

Full Information

First Posted
February 14, 2007
Last Updated
August 21, 2009
Sponsor
University of Toronto
Collaborators
Canadian Institutes of Health Research (CIHR), The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT00435500
Brief Title
Fluoride Varnish in the Prevention of Dental Caries in Aboriginal and Non-aboriginal Children
Official Title
Fluoride Varnish in the Prevention of Dental Caries in Aboriginal and Non-aboriginal Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Toronto
Collaborators
Canadian Institutes of Health Research (CIHR), The Hospital for Sick Children

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Dental caries, topical fluorides

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
1320 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fluoride varnish
Primary Outcome Measure Information:
Title
Reduction in the 2-year caries increment (dmfs/DMFS index); final follow-up at 24 months.
Secondary Outcome Measure Information:
Title
(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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
71 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herenia P. Lawrence, DDS, PhD
Organizational Affiliation
University of Toronto, Faculty of Dentistry, Toronto, Ontario, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sioux Lookout Zone Dental Program
City
Sioux Lookout
State/Province
Ontario
ZIP/Postal Code
P8T 1C2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
18422711
Citation
Lawrence HP, Binguis D, Douglas J, McKeown L, Switzer B, Figueiredo R, Laporte A. A 2-year community-randomized controlled trial of fluoride varnish to prevent early childhood caries in Aboriginal children. Community Dent Oral Epidemiol. 2008 Dec;36(6):503-16. doi: 10.1111/j.1600-0528.2008.00427.x. Epub 2008 Apr 14.
Results Reference
derived
Links:
URL
http://www.caphd-acsdp.org/PDF/Aboriginal%20Preschool.pdf
Description
Click here for more information about this study: A 2-year Community Trial of Fluoride Varnish for the Prevention of Early Childhood Caries in Aboriginal Children
URL
http://www.ncbi.nlm.nih.gov/pubmed/18422711?ordinalpos=9&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum
Description
Results of A Fluoride Varnish Trial to Prevent and Reduce Caries in Aboriginal Children

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

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