ART restorations for occluso-proximal cavities in primary molars: a two-year survival and cost analysis of an RCT comparing two GIC brands

ABSTRACT

Abstract There are many glass ionomer cements available on the Brazilian market for Atraumatic Restorative Treatment (ART), however, there is still a gap in the literature regarding their cost-effectiveness. Objectives To evaluate the influence of restorative materials (Ketac Molar, 3M ESPE; and Vitro Molar, Nova DFL) in the two-year survival rate and cost-effectiveness of occluso-proximal ART restorations in primary molars. Methodology A total of 117 children (aged four to eight years) with at least one occluso-proximal carious lesion in primary molars were selected and randomly divided in treatment groups (KM or VM) in this parallel randomized controlled trial. Treatments followed ART premises and were conducted in public schools by trained operators in Barueri, Brazil. A trained, calibrated, and blinded examiner performed the evaluations after two, six, 12, and 24 months (k=0.92). Kaplan-Meier survival analysis was used to estimate restoration survival and Cox regression was used to test the association with clinical factors (α=5%). For cost analysis, material and professional costs were considered. Monte Carlo analysis was used to generate a cost-effectiveness plane and bootstrapping was used to compare material costs over the years. Results The overall survival rate was 36.9% after two years (48.6% for KM and 25.4% for VM). Restorations with VM failed more than those with KM (HR=1.70; 95% CI=1.06-2.73; p=0.027). VM presented lower initial cost, but no difference was observed between groups considering the two-year incremental cost. Conclusion After a two-year evaluation, KM proved to be a better option than VM for occluso-proximal ART restorations in primary molars. ClinicalTrials.gov: NCT02267720