NCT03429829

Fluoride Varnish Community Trial

Fluoride Varnish for Caries Prevention in South African Children: A Cluster-randomized Controlled Community Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 513 (actual)
• Sponsor: DMG Dental Material Gesellschaft mbH · Industry
• Sex: All
• Age: 4 Years – 8 Years
• Healthy volunteers: Accepted

Summary

This cluster-randomized controlled community trial aimed to assess the efficacy and costs of fluoride varnish application for caries prevention in a high-risk population in South Africa.

Detailed 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 (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.

Conditions

• Dental Caries
• Oral Disease
• Costs

Interventions

Type	Name	Description
DEVICE	Flairesse varnish	Flairesse is applied to enamel and dentine as protective varnish to prevent caries formation and to promote remineralization of initial caries. It is also used in the treatment of hypersensitive teeth by sealing dentin tubules and hypersensitive areas at the neck of the tooth and exposed root dentine. Flairesse varnish contains xylitol and fluoride (22,600 ppm). Both components have been well established for oral health by reducing caries prevalence and incidences. During the application, children sat upright; their teeth were first cleaned and dried with cotton wool rolls. After mixing the fluoride varnish, it was applied as a thin layer to all surfaces of the lower and upper dentition, including proximal surfaces (using floss in case of tight contact points) as well as pits and fissures (using a small brush that was provided together with the varnish by the manufacturer). Children were advised not to drink or eat directly after the application, while this could not be controlled.

Timeline

• Start date: 2018-02-12
• Primary completion: 2020-02-19
• Completion: 2020-02-19
• First posted: 2018-02-12
• Last updated: 2022-04-20

Locations

2 sites across 1 country: South Africa