Clinical investigation of a high-strength glass ionomer restorative used with the ART technique in Wuhan, China: one-year results.

Abstract

OBJECTIVE: To evaluate the safety and effectiveness of a new glass ionomer restorative, ChemFlex, and to compare its clinical performance and wear to another popular material, Fuji IX GP, when used with the atraumatic restorative treatment (ART) approach in posterior teeth in school children. METHODS: Ninety-two subjects aged between 6 and 14 years who had bilateral matched pairs of carious posterior teeth were selected. A split-mouth experimental design was used in which the two restorative materials were randomly placed on contralateral sides. The restorations were assessed directly and also indirectly from color transparencies and die replicas. RESULTS: After one year, the success rates of ART restorations in the primary teeth were 96.6% for ChemFlex restorations and 89.7% for Fuji IX GP restorations placed in the Class I cavity preparations, whereas only 46.2% (ChemFlex) and 61.5% (Fuji IX GP) of Class II restorations were assessed as clinically satisfactory. In the permanent dentition, the success rates were 94.6% and 98.2% for ChemFlex and Fuji IX GP, respectively; however, there was no statistically significant difference between the two restoratives for either the permanent or primary teeth. The mean occlusal wear after one year in the permanent teeth was 53.2 microns for ChemFlex and 56.3 microns for Fuji IX GP. Again, there were no statistically significant differences in wear between the two materials (P > 0.05). CONCLUSION: The clinical performance of both ChemFlex and Fuji IX GP over a 12-month period was highly satisfactory and completely adequate for the ART technique, particularly in Class I cavities.