Fluoride Varnish Community Trial

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries; Oral Disease; Costs
• Intervention / Treatment: Device: Flairesse varnish

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 Type: Interventional
• Enrollment (Actual): 513
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Western Cape
    • Mfuleni, Western Cape, South Africa, 7100
      • Itsitsa Primary School
    • Mfuleni, Western Cape, South Africa, 7100
      • Nyameko Primary School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increment of teeth with cavitated lesions, restorations or extraction.	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.	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: DMG Dental Material Gesellschaft mbH
• Collaborators: Dental Wellness Trust (DWT); University of Western Cape (UWC)

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2018
• Primary Completion (Actual): February 19, 2020
• Study Completion (Actual): February 19, 2020

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Costs; Caries; Fluoride Varnish; Dental Health
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Mouth Diseases
• Other Study ID Numbers: Wellflair

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No