Fluoride Varnish Community Trial

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03429829
• Other study ID #: Wellflair
• Status: Completed
• Phase: N/A
• Start date: February 12, 2018
• Est. completion date: February 19, 2020

Study information

• Verified date: April 2022
• Source: DMG Dental Material Gesellschaft mbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 513
• Est. completion date: February 19, 2020
• Est. primary completion date: February 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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)

Related Conditions & MeSH terms

• Costs
• Dental Caries
• Mouth Diseases
• Oral Disease

Intervention

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.

Locations

Country	Name	City	State
South Africa	Itsitsa Primary School	Mfuleni	Western Cape
South Africa	Nyameko Primary School	Mfuleni	Western Cape

Sponsors (3)

Lead Sponsor	Collaborator
DMG Dental Material Gesellschaft mbH	Dental Wellness Trust (DWT), University of Western Cape (UWC)

Country where clinical trial is conducted

South Africa, 

Outcome

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