Dental CariesPhase 3NCT00435500
Fluoride Varnish in the Prevention of Dental Caries in Aboriginal and Non-aboriginal Children
A Phase 3 study testing Fluoride varnish in people with Dental Caries, run by University of Toronto at 1 site in Canada.
Trial 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 more about this study
- Who is it for?
- Ages 6 to 71 monthsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Fluoride varnish
- How many people
- 1,320 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2003to Jan 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 71 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Dental Caries
- Being tested
- Fluoride varnish
- Keywords
- Dental caries, topical fluorides
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride varnishDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2007 (estimated)
- Study startJun 2003
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 1,320 participants
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Hospital for Sick Children
- Investigators
- Herenia P. Lawrence, DDS, PhD, Principal investigator, University of Toronto, Faculty of Dentistry, Toronto, Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435500
- Sponsor's protocol ID
- MOP-64215
- Status last verified
- Aug 2009
- First submitted
- 14 Feb 2007
- Last updated
- 25 Aug 2009
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoride Varnish in the Prevention of Dental Caries in Aboriginal and Non-aboriginal Children
- ClinicalTrials.gov ID
- NCT00435500
- Acronym / sponsor ID
- MOP-64215
- Conditions
- Dental Caries
- Keywords
- Dental caries, topical fluorides
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,320 participants
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Hospital for Sick Children
- Study start
- Jun 2003
- Study completion
- Jan 2006
- First posted
- 15 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 6 to 71 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoride varnish | Drug | – |
Primary outcome
Reduction in the 2-year caries increment (dmfs/DMFS index); final follow-up at 24 months.
1 secondary outcome
(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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2009.
- Derived from this study: PubMed 18422711Lawrence 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.
- 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 ChildrenLink provided by the sponsor.
- Results of A Fluoride Varnish Trial to Prevent and Reduce Caries in Aboriginal ChildrenLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herenia P. Lawrence, DDS, PhD principal investigator
University of Toronto, Faculty of Dentistry, Toronto, Ontario, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluoride varnish in people with Dental Caries, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the 2-year caries increment (dmfs/DMFS index); final follow-up at 24 months.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00435500, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2009.