Dental Caries Clinical Trial
Official title:
Fluoride Varnish for Caries Prevention in South African Children: A Cluster-randomized Controlled Community Trial
Verified date | April 2022 |
Source | DMG Dental Material Gesellschaft mbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 513 |
Est. completion date | February 19, 2020 |
Est. primary completion date | February 19, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 8 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
South Africa | Itsitsa Primary School | Mfuleni | Western Cape |
South Africa | Nyameko Primary School | Mfuleni | Western Cape |
Lead Sponsor | Collaborator |
---|---|
DMG Dental Material Gesellschaft mbH | Dental Wellness Trust (DWT), University of Western Cape (UWC) |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Increment of teeth with cavitated lesions or restorations. | The increment of teeth with cavitated caries lesions, receiving or requiring a restoration. | 2 years | |
Secondary | Increment of extracted teeth. | The increment of teeth which were extracted due to caries. | 2 years | |
Secondary | Cost | Initial costs of fluoride varnish application and re-treatment costs. | 2 years |
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