Randomized Clinical Trial of Heated High Viscosity Glass Ionomer Class II Restorations in Deciduous Molars: 12 Months Follow Up

Objective: New generation High Viscosity Glass Ionomer Cements (HVGICs) have enhanced physical and mechanical properties. By effectively closing the restoration margin, it ensures that the restorations will last longer. The aim of this study was to investigate the clinical performances of heat-cured versus non heated HVGIC in class II restorations of deciduous molars. Methods: This randomized, split mouth, multicentre study was performed in four different centres. A total of 250 deciduous molars from 88 individuals were randomly allocated to one of the following groups: 1) non-heated (n =125) 2) heated (n = 125) and restored with a HVGIC using LED light for heat application. Restorations were clinically evaluated according to the modified USPHS at the baseline, 6 months and 12 months. The survival analysis was performed by Kaplan Meier and Life Tables. This study was retrospectively registered to the ClinicalTrials.gov with the ID number of NCT04291872 at 2nd March 2020. Results: No statistically significant differences were found between the groups regarding to modified USPHS criteria (p>0.05). Success rate in retention criteria was 94.1% of the heat-cured and 92.6% of the non-heated restorations after 12 months. The mean survival time was 11.8 +/- 0.1 months in the heated group, while 11.9 +/- 0.1 months in the non-heated group. Conclusion: The heat treated HVGIC for Class II restorations did not show any significant differences in 12 months' follow-up compared with the conventional technique.