Objective: The aim of this prospective study was to evaluate the clinical performance of a new restorative material (Ceram∙X) in combination with a new one-bottle adhesive (K-0127).

Methods: One operator placed two Class I or II restorations in molars of 43 patients. One molar was restored with Ceram∙X/K-0127 (Dentsply DeTrey; Konstanz, Germany), the other one with Tetric Ceram/Syntac Classic (Ivoclar Vivadent; Schaan, Liechtenstein). At baseline, after one, two and four years the restorations were evaluated by one evaluator using modified Ryge's criteria. After four years 27 patients were examined.

Results: In one patient both restorations had to be removed for root canal treatment due to pulpitis. Another Ceram∙X restoration (3.8%) showed score C with regard to wear/anatomical form. Thus, cumulative failure rate was 7.4% in the Ceram∙X group and 3.7% in the Tetric Ceram group. Furthermore, anatomical form and marginal integrity was score B for three restorations (11.5%) in each group. Slight marginal discoloration (score B) was found concerning five Ceram∙X restorations (19.2%) and four Tetric Ceram restorations (15.4%). Two restorations (7.7%) in each group showed slight changes in color stability (score B). In both groups no sensitivity, no recurrent caries and no changes in surface texture were recorded after four years. No statistically significant differences were found between the two restorative materials (p > 0.05).

Conclusion: After four years of clinical service, 92.6% of Ceram∙X/K-0127 and 96.3% of Tetric Ceram/Syntac Classic restorations were in place and performed clinically well.

The present study was supported by DENTSPLY DeTrey (Konstanz, Germany; investigation number: K-0127 / K-0137 / 14.1007).

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