Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00435500
Status:
UNKNOWN
Last Update Posted:
2009-08-25
First Post:
2007-02-14
Brief Title:
Fluoride Varnish in the Prevention of Dental Caries in Aboriginal and Non-aboriginal Children
Sponsor:
University of Toronto
Organization:
University of Toronto
Study Overview
Official Title:
Fluoride Varnish in the Prevention of Dental Caries in Aboriginal and Non-aboriginal Children
Status:
UNKNOWN
Status Verified Date:
2009-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 2-3yr The same subjects were examined for the dmfts 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 childrens 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 Units dental hygienists and recorders Results will assist decision makers in developing programs for addressing the problem of ECC in high-caries-risk populations
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 2-3yr The same subjects were examined for the dmfts 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 childrens 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 Units dental hygienists and recorders Results will assist decision makers in developing programs for addressing the problem of ECC in high-caries-risk populations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None