Clinical evaluation of two glass ionomer cement restorations placed in primary molars with atraumatic restorative treatment technique: a randomized controlled trial.

Abstract

Objective: The purpose of this study was to compare clinical success of a novel material (silver diamine fluoride incorporated with high-viscosity glass ionomer cement (SDF-GIC)) in Class II restoration in primary molars using atraumatic restorative treatment (ART) technique at 6- and 12- month follow-up.

Materials and Methods: A randomized controlled clinical trial using a parallel group design was carried out on 150 children aged 3-8 years old, from 5 public school in Samut Sakhon province, Thailand, with at least one class II cavities. They were randomly allocated to two treatment groups: ART restoration using either GIC (Fuji IX GP) or SDF-HVGIC (Fuji IX GP + Saforide). A total of 150 restorations were placed in vital primary molars by a pediatric dentist (HVGIC= 75, SDF-HVGIC= 75) and were evaluated­­ by one calibrated examiner, blinded to the type of material and not involved in the placement after 6 and 12 months. Results: The overall clinical success (95 percent confidence interval) at the 6-month follow-up for the GIC and SDF-GIC were 73.3 percent (61.9-82.9) and 62.76 percent (50.7-73.6), respectively. At 12-month follow-up, the clinical success for SDF-GIC and GIC were 61.3 percent (49.4-72.4) and 58.7 percent (46.7-69.9), respectively. However, no significant difference was detected in clinical success between the study groups for both follow-up periods (Chi’s square, p=0.161 for 6-month and p=0.739 for 12-month).

Conclusion: Class II ART restorations with the novel material (SDF-GIC) showed similar clinical success rate after 6 and 12 months compared to those with GIC.