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Completed

NCT Number: NCT03429829

Fluoride Varnish 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.

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Key information

Conditions

Dental Caries Costs Mouth Diseases Oral Disease Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Itsitsa Primary School, Mfuleni, Western Cape, South Africa

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Flairesse varnish

Device

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.

Primary outcomes

  1. Increment of teeth with cavitated lesions, restorations or extraction.

    Time frame: 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 outcomes

  1. Increment of teeth with cavitated lesions or restorations.

    Time frame: 2 years

    The increment of teeth with cavitated caries lesions, receiving or requiring a restoration.

  2. Increment of extracted teeth.

    Time frame: 2 years

    The increment of teeth which were extracted due to caries.

  3. Cost

    Time frame: 2 years

    Initial costs of fluoride varnish application and re-treatment costs.

Sponsors and collaborators

Lead sponsor

DMG Dental Material Gesellschaft mbH

Industry

Collaborators

  • Dental Wellness Trust (DWT)
  • University of Western Cape (UWC)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 12, 2018
Registry last updated
Apr 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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