Status:
COMPLETED
Fluoride Varnish Community Trial
Lead Sponsor:
DMG Dental Material Gesellschaft mbH
Collaborating Sponsors:
Dental Wellness Trust (DWT)
University of Western Cape (UWC)
Conditions:
Dental Caries
Oral Disease
Eligibility:
All Genders
4-8 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Reception grad or grade 1 (age 4-8)
- Signed consent form
- Good general health
Exclusion
- Any allergies (especially sticking plaster)
- History of asthma
- Chronic Ulcerated gums
- Chronic Stomatis
- Participation in other study (except LifeSmart)
Key Trial Info
Start Date :
February 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2020
Estimated Enrollment :
513 Patients enrolled
Trial Details
Trial ID
NCT03429829
Start Date
February 12 2018
End Date
February 19 2020
Last Update
April 20 2022
Active Locations (2)
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1
Itsitsa Primary School
Mfuleni, Western Cape, South Africa, 7100
2
Nyameko Primary School
Mfuleni, Western Cape, South Africa, 7100