Fluoride Varnish Community Trial

Not Applicable

Completed

• Conditions: Dental Caries; Costs; Oral Disease
• Interventions: Device: Flairesse varnish

• Registration Number: NCT03429829
• Lead Sponsor: DMG Dental Material Gesellschaft mbH

Brief 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.

Study Timeline

• Study First Submitted: 2018-01-29
• Study First Submitted QC: 2018-02-05
• Study Start: 2018-02-12
• Study First Posted: 2018-02-12
• Primary Completion: 2020-02-19
• Study Completion: 2020-02-19
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 513

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flairesse varnish	Flairesse varnish	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.

Primary Outcome Measures

Name	Time	Method
Increment of teeth with cavitated lesions, restorations or extraction.	2 years	The primary outcome was the increment of teeth with cavitated lesions (i.e. newly developed ones or progressed, formerly non-cavitated lesions), requiring restorations or extraction.

Secondary Outcome Measures

Name	Time	Method
Increment of teeth with cavitated lesions or restorations.	2 years	The increment of teeth with cavitated caries lesions, receiving or requiring a restoration.
Increment of extracted teeth.	2 years	The increment of teeth which were extracted due to caries.
Cost	2 years	Initial costs of fluoride varnish application and re-treatment costs.

Trial Locations

Locations (2)

Nyameko Primary School; 🇿🇦 Mfuleni, Western Cape, South Africa

Itsitsa Primary School; 🇿🇦 Mfuleni, Western Cape, South Africa