IADR Abstract Archives
Two Year Results of a Clinical Trial With two Basic Filling Materials in Cambodia
Objectives: To compare the success of GIC (GC - Fuji IX) and Cention-N (Ivoclar Vivadent) restorations in Class II cavities on the permanent teeth of young adults in Cambodia.
Methods: This study was a randomized controlled clinical trial involving students from the University of Puthisastra. Ethical approval was obtained from the Cambodian National Health Research Ethical Committee. Following an examination and PBW radiographs to identify caries, students who met the inclusion criteria (ICDAS code 4 or 5 proximal lesions on molars/premolars) for the trial were invited to participate and provided informed consent. Restorations were placed by two experienced dentists and the material used was based on random allocation of either an ion-releasing, self-curing, resin-based material Cention N (Ivoclar Vivadent), or Fuji IX Glass Ionomer Cement (GIC). A third calibrated dentist evaluated the restorations (clinically and radiographically) at the 2-year follow-up using the FDI criteria.
Results: 238 restorations were placed (124 Cention-N vs 114 GIC) and 176 (73.9%) were followed at 2-years. Four participants representing 13 restorations chose to withdraw from the study. There was a statistically significant difference in the failure of restorations whereby GIC restorations were six-times more likely to fail (P-value <0.001;chi squared test). 2 Cention-N restorations failed (2.7%) compared with 12 GIC restorations (10.7%).
Conclusions: Cention N restorations had a significantly higher success rate (97.3%) after two years compared with Fuji IX GIC restorations (success rate 89.3%). The success rate of Cention N restorations is comparable to clinical studies using other composite restorative materials.
Methods: This study was a randomized controlled clinical trial involving students from the University of Puthisastra. Ethical approval was obtained from the Cambodian National Health Research Ethical Committee. Following an examination and PBW radiographs to identify caries, students who met the inclusion criteria (ICDAS code 4 or 5 proximal lesions on molars/premolars) for the trial were invited to participate and provided informed consent. Restorations were placed by two experienced dentists and the material used was based on random allocation of either an ion-releasing, self-curing, resin-based material Cention N (Ivoclar Vivadent), or Fuji IX Glass Ionomer Cement (GIC). A third calibrated dentist evaluated the restorations (clinically and radiographically) at the 2-year follow-up using the FDI criteria.
Results: 238 restorations were placed (124 Cention-N vs 114 GIC) and 176 (73.9%) were followed at 2-years. Four participants representing 13 restorations chose to withdraw from the study. There was a statistically significant difference in the failure of restorations whereby GIC restorations were six-times more likely to fail (P-value <0.001;chi squared test). 2 Cention-N restorations failed (2.7%) compared with 12 GIC restorations (10.7%).
Conclusions: Cention N restorations had a significantly higher success rate (97.3%) after two years compared with Fuji IX GIC restorations (success rate 89.3%). The success rate of Cention N restorations is comparable to clinical studies using other composite restorative materials.