Fluoride Varnish Community Trial

NACompletedINTERVENTIONAL
Enrollment

513

Participants

Timeline

Start Date

February 12, 2018

Primary Completion Date

February 19, 2020

Study Completion Date

February 19, 2020

Conditions
Dental CariesOral DiseaseCosts
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."

Trial Locations (2)

7100

Itsitsa Primary School, Mfuleni

Nyameko Primary School, Mfuleni

All Listed Sponsors
collaborator

Dental Wellness Trust (DWT)

UNKNOWN

collaborator

University of Western Cape (UWC)

UNKNOWN

lead

DMG Dental Material Gesellschaft mbH

INDUSTRY

NCT03429829 - Fluoride Varnish Community Trial | Biotech Hunter | Biotech Hunter