Survival of the fittest: does Riva Self Cure outperform Equia Forte when used to restore mesio-occlusal cavities in atraumatic restorative technique?

Abstract

Double-blind (participant and outcome assessor), randomised, non-inferiority, two-arm (1:1 allocation) clinical trial. The study included children aged 4–8 years old from public schools in Tietê, Brazil, who had mesio-occlusal carious lesions, into dentine, in primary molars. The carious teeth had to be asymptomatic of pulpal involvement. The children had to be medically fit and cooperative for dental treatment within their classroom environment. Consent was gained from a parent/guardian prior to entering the study. Children with carious lesions in multiple teeth, only one tooth was included, which was selected by a random draw. Treatment on other teeth would be carried out in the nearest health centre. The primary outcome was the 2-year survival of the restorations, analysed using Kaplan–Meier survival curves and Cox regression (α = 5%). Costs for materials and professional services were recorded in Brazilian Reais (R$), converted to US dollars (US$), and analysed using Monte Carlo simulation. Of the 152 children enrolled (76 per group), 121 (79%) were evaluated at the 2-year mark. Overall, the 2-year survival rate of the restorations was 39% (EF: 45%; RSC: 32%), with no significant difference between the two groups. The total cost of restorations with RSC was lower than with EF, resulting in a cost saving of US$6.18 per restoration. After 2 years, Riva Self Cure demonstrated comparable survival rates to Equia Forte for mesio-occlusal restorations in primary molars, while being more cost-effective from a Brazilian perspective.