Fluoride Varnish Community Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 640
Summary
- Conditions
- Costs
- Dental Caries
- Oral Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Children in the reception grade and grade 1 of two schools in a township in South Africa are class-wise cluster-randomized to the fluoride varnish or control groups.Masking: Single (Outcomes Assessor)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 4 years and 8 years
- Gender
- Both males and females
Description
Despite advances in oral health, dental caries remains a significant problem - particularly in disadvantaged communities in low- and middle-income countries. A study in the Western Cape Region, which was conducted between 2001 and 2015, reported for example a caries prevalence of 84% for 6-years-old...
Despite advances in oral health, dental caries remains a significant problem - particularly in disadvantaged communities in low- and middle-income countries. A study in the Western Cape Region, which was conducted between 2001 and 2015, reported for example a caries prevalence of 84% for 6-years-old (Smit 2017), highlighting the need for oral health programs and cost-effective interventions. Fluoride varnish offers hereby a feasible possibility to supplement toothbrushing programs in order to improve fluoride delivery and consequently caries prevention. However, many studies failed to confirm the benefits of fluoride varnish for caries prevention, which may partially be explained by the fact that many of these studies were conducted in high-income countries, in which the caries increment is low due to a wide access to fluoride. This study, thus aimed to further validate the benefits of fluoride varnish application specifically in a primary school setting within a peri-urban, low socio-economic, high-caries risk community in South Africa.
Tracking Information
- NCT #
- NCT03429829
- Collaborators
- Dental Wellness Trust (DWT)
- University of Western Cape (UWC)
- Investigators
- Not Provided
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