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Fluoride Varnish Community Trial

NCT03429829 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 513

Last updated 2022-04-20

No results posted yet for this study

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.

Conditions

  • Dental Caries
  • Oral Disease
  • Costs

Interventions

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.

Sponsors & Collaborators

  • Dental Wellness Trust (DWT)

    collaborator UNKNOWN

  • University of Western Cape (UWC)

    collaborator UNKNOWN

  • DMG Dental Material Gesellschaft mbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-12
Primary Completion
2020-02-19
Completion
2020-02-19

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03429829 on ClinicalTrials.gov