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Fluoride Varnish Community Trial

Primary Purpose

Dental Caries, Oral Disease, Costs

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Flairesse varnish
Sponsored by
DMG Dental Material Gesellschaft mbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring Caries, Fluoride Varnish, Dental Health, Costs

Eligibility Criteria

4 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Itsitsa Primary School
  • Nyameko Primary School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Flairesse varnish

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Increment of teeth with cavitated lesions or restorations.
The increment of teeth with cavitated caries lesions, receiving or requiring a restoration.
Increment of extracted teeth.
The increment of teeth which were extracted due to caries.
Cost
Initial costs of fluoride varnish application and re-treatment costs.

Full Information

First Posted
January 29, 2018
Last Updated
April 19, 2022
Sponsor
DMG Dental Material Gesellschaft mbH
Collaborators
Dental Wellness Trust (DWT), University of Western Cape (UWC)
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1. Study Identification

Unique Protocol Identification Number
NCT03429829
Brief Title
Fluoride Varnish Community Trial
Official Title
Fluoride Varnish for Caries Prevention in South African Children: A Cluster-randomized Controlled Community Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
February 19, 2020 (Actual)
Study Completion Date
February 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DMG Dental Material Gesellschaft mbH
Collaborators
Dental Wellness Trust (DWT), University of Western Cape (UWC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Oral Disease, Costs
Keywords
Caries, Fluoride Varnish, Dental Health, Costs

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
513 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flairesse varnish
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Flairesse varnish
Intervention Description
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 Outcome Measure Information:
Title
Increment of teeth with cavitated lesions, restorations or extraction.
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Increment of teeth with cavitated lesions or restorations.
Description
The increment of teeth with cavitated caries lesions, receiving or requiring a restoration.
Time Frame
2 years
Title
Increment of extracted teeth.
Description
The increment of teeth which were extracted due to caries.
Time Frame
2 years
Title
Cost
Description
Initial costs of fluoride varnish application and re-treatment costs.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Itsitsa Primary School
City
Mfuleni
State/Province
Western Cape
ZIP/Postal Code
7100
Country
South Africa
Facility Name
Nyameko Primary School
City
Mfuleni
State/Province
Western Cape
ZIP/Postal Code
7100
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
No

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Fluoride Varnish Community Trial

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