PURPOSE: To evaluate the effect of a chlorhexidine-gluconate-based cavity disinfectant on the clinical performance of high viscosity glass-ionomer cement following the ART approach under field conditions after 24 months. METHODS:126 school children 6-8 years old who had bilateral matched pairs of carious Class I and II primary molars were included. A split mouth design was used in which Ketac Molar was randomly placed with or without the use of chlorhexidine-gluconate-based cavity disinfectant on contralateral sides by three dentists. The restorations were evaluated after 6, 12 and 24 months by two experienced examiners using USPHS-Ryge criteria. RESULTS: The 24-month mean cumulative survival rates of Ketac Molar without the use of disinfectant were 97.7% and 69.4% while in the disinfectant group, the survival rates were 95.2% and 63.9% in Class I and II restorations, respectively with no significant difference between the groups in both class types. In the non-disinfected group, large Class II cavities had significantly better survival rates than did small Class II cavities (P = 0.023). In the disinfected group, the failure rates in mean cumulative survivals from 6 to 12 months and 12 to 24 months significantly increased with time (P = 0.004 and P = 0.016 respectively).
RCT Entities:
PURPOSE: To evaluate the effect of a chlorhexidine-gluconate-based cavity disinfectant on the clinical performance of high viscosity glass-ionomer cement following the ART approach under field conditions after 24 months. METHODS: 126 school children 6-8 years old who had bilateral matched pairs of carious Class I and II primary molars were included. A split mouth design was used in which Ketac Molar was randomly placed with or without the use of chlorhexidine-gluconate-based cavity disinfectant on contralateral sides by three dentists. The restorations were evaluated after 6, 12 and 24 months by two experienced examiners using USPHS-Ryge criteria. RESULTS: The 24-month mean cumulative survival rates of Ketac Molar without the use of disinfectant were 97.7% and 69.4% while in the disinfectant group, the survival rates were 95.2% and 63.9% in Class I and II restorations, respectively with no significant difference between the groups in both class types. In the non-disinfected group, large Class II cavities had significantly better survival rates than did small Class II cavities (P = 0.023). In the disinfected group, the failure rates in mean cumulative survivals from 6 to 12 months and 12 to 24 months significantly increased with time (P = 0.004 and P = 0.016 respectively).