Fluoride Varnish Community Trial

NCT03429829 | Completed

• 1 other identifier: Wellflair
• Study Type: interventional
• Target: 513
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Caries; Fluoride Varnish; Dental Health; Costs

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Increment of teeth with cavitated lesions or restorations.

  2 years

• Increment of extracted teeth.

  2 years

• Cost

  2 years

Study Arms (2)

Flairesse varnish

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

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.

Flairesse varnish

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Reception grad or grade 1 (age 4-8)
• Signed consent form
• Good general health

You may not qualify if:

• Any allergies (especially sticking plaster)
• History of asthma
• Chronic Ulcerated gums
• Chronic Stomatis
• Participation in other study (except LifeSmart)

Sponsors & Collaborators

• DMG Dental Material Gesellschaft mbH: lead
• Dental Wellness Trust (DWT): collaborator
• University of Western Cape (UWC): collaborator

Study Sites (2)

Itsitsa Primary School

Mfuleni, Western Cape, 7100, South Africa

Location

Nyameko Primary School

Mfuleni, Western Cape, 7100, South Africa

Location

MeSH Terms

Conditions

Dental Caries; Mouth Diseases

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Children in the reception grade and grade 1 of two schools in a township in South Africa are class-wise cluster-randomized to the fluoride varnish or control groups.

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 12, 2018
• Study Start: February 12, 2018
• Primary Completion: February 19, 2020
• Study Completion: February 19, 2020
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (2)