Fluoride Varnish Community Trial

Dental Material Gesellschaft

Status: Completed

Conditions: Dental Caries; Costs; Oral Disease

Treatments: Device: Flairesse varnish

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03429829

Wellflair

Details and patient eligibility

About

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.

Full 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.

Enrollment: 513 patients

Sex: All

Ages: 4 to 8 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Reception grad or grade 1 (age 4-8)
• Signed consent form
• Good general health

Exclusion criteria

• Any allergies (especially sticking plaster)
• History of asthma
• Chronic Ulcerated gums
• Chronic Stomatis
• Participation in other study (except LifeSmart)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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513 participants in 2 patient groups

Flairesse varnish

Experimental group

Description:

Children were part of the LiveSmart tooth brushing program. They all received a new toothbrush at baseline and at every follow-up visit as well as fluoridated toothpaste. Their daily toothbrushing was supervised by the local trained non-professional assistant. In addition, fluoride varnish (22.600 ppm, DMG, Hamburg, Germany) was applied in 3-monthly intervals by the local non-professional assistants who had been trained beforehand and supervised at the first application.

Treatment:

Device: Flairesse varnish

Control

No Intervention group

Description:

Children were part of the LiveSmart tooth brushing program. They all received a new toothbrush at baseline and at every follow-up visit as well as toothpaste. Their daily toothbrushing was supervised by the local trained non-professional assistant. Beyond that, the children in this arm were left untreated.