Low-cost glass ionomer cements hamper the performance of occlusal ART restorations - 2y survival and economic analysis of a RCT

OBJECTIVES: The aim of this clinical trial was to evaluate the 2-year survival rate and cost-analysis of Atraumatic Restorative Treatment (ART) restorations using three different glass ionomer cements (GICs) for occlusal restorations in primary molars. METHODS: After trial registration (NCT02377297) and ethical approval (#569,123), a total of 150 4-8 y old children were randomly allocated and treated on a school setting using Fuji IX (GC Corp), Vitro Molar (nova DFL) or Maxxion R (FGM), following ART premises. Materials and professionals costs were measured in Brazilian real (1,0 R$≈0.3USD) and considered to analyze baseline costs, while an estimation was done for treatments' incremental cost. Restoration survival was evaluated using Kaplan-Meier survival analysis, while Cox regression was used for testing association with clinical factors and Bootstrap regression (1000 repetitions) was used to perform a cost-analysis (α = 5%). RESULTS: The overall 2-year survival rate was 53% (Fuji IX = 72.7%; Vitro Molar =46.5%; Maxxion R=39.6%). Restorations performed with Vitro Molar and Maxxion R are more likely to fail when compared to Fuji IX. Considering the baseline cost, Fuji IX was the more expensive option (p<0.001) (Fuji IX = R$18.7; Vitro Molar =R$14.6; Maxxion R=R$13.5). However, considering the simulation of incremental cost caused by failures until 2-year evaluation, no difference was found between the groups. CONCLUSIONS: After 2 years, restorations performed with Fuji IX proved to be superior in terms of survival and with a similar cost when compared to other low-cost glass ionomers cements.