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Survival Rate and Cost-effectiveness of Conventional vs ART Restorations in a School Setting
Sponsor: DMG Dental Material Gesellschaft mbH
Summary
This study will investigate the performance and cost-effectiveness of glass-ionomer restorations placed in school children in an outreach setting in rural areas in South Africa over a 2-year period, when placed using either ART (in a classroom) or conventional (in a mobile clinic) cavity preparation.
Official title: Survival Rate and Cost-effectiveness of Glass Ionomer Restorations in the Primary Molars Using ART and Conventional Cavity Preparations in South African Children: a Randomized Controlled Non Inferiority Trial
Key Details
Gender
All
Age Range
4 Years - 8 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2025-02-24
Completion Date
2027-02
Last Updated
2026-04-13
Healthy Volunteers
No
Conditions
Interventions
Atraumatic Restorative Treatment (ART)
Conventional glass-ionomer restorations are placed using the Atraumatic Restorative Treatment (ART) technique. Essentially, cavities are prepared using hand instrument excavators. Afterwards, the cavity is conditioned (using a 10% polyacrylic acid conditioner) and cleaned, with subsequent insertion of a conventional restorative glass-ionomer. During the curing phase, Vaseline will be applied to all restoration surfaces for moisture protection. The treatment will be conducted in a class room. As concomitant treatment, all participants will receive supervised toothbrushing during the study using 1,450 ppm fluoride toothpaste once a day.
Conventional Cavity Preparation
Conventional glass-ionomer restorations are placed after conventional cavity preparation. Essentially, cavities are prepared using rotary instruments/diamond burs. Afterwards, the cavity is conditioned (using a 10% polyacrylic acid conditioner) and cleaned, with subsequent insertion of a conventional restorative glass-ionomer. During the curing phase, Vaseline will be applied to all restoration surfaces for moisture protection. The treatment will be conducted in a mobile clinic. As concomitant treatment, all participants will receive supervised toothbrushing during the study using 1,450 ppm fluoride toothpaste once a day.
Locations (1)
Nyameko and Itsitsa Primary Schools
Mfuleni, Western Cape, South Africa