CClinicalTrials.gg
Status unknownNCT00435500Updated Aug 25, 2009

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

A Phase 3 interventional study of Fluoride varnish in Dental Caries, sponsored by University of Toronto. Status unknown at 1 site in Canada. Open to participants aged 6 Months to 71 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-08-25.

Sponsored by University of Toronto · Phase 3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2009), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
1,320
Allocation
Randomized
Ages
6 Months to 71 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dental Caries

Browse trials for

Keywords

  • Dental caries, topical fluorides
03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's enrollment of 1,320 is above the median of 60 across 915 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

University of Toronto is the lead sponsor of 397 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 71 Months
Sexes eligible
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

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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
1,320 participants

Interventions

  • DrugFluoride varnish
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  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

07

Study locations

1 site
  • Sioux Lookout Zone Dental Program
    Sioux Lookout, Ontario P8T 1C2, Canada
08

References and documents

Publications

  • 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. PubMed 18422711 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00435500
Lead sponsor
University of Toronto
Collaborators
Canadian Institutes of Health Research (CIHR), The Hospital for Sick Children
First posted
Feb 15, 2007
Start date
Jun 2003
Completion
Jan 2006
Last update
Aug 25, 2009

Study contacts

Herenia P. Lawrence, DDS, PhD
principal investigator · University of Toronto, Faculty of Dentistry, Toronto, Ontario, Canada
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion