Two-year evaluation of a new nano-ceramic restorative material.

The purpose of this prospective study was to evaluate the clinical performance of a new restorative material (Ceram.X) in combination with a new primer-adhesive (K-0127). One operator placed two Class I or II restorations in molars of 43 patients. One molar was restored with Ceram.X/K-0127, the other one with Tetric Ceram/Syntac Classic. At baseline, after 1 and 2 years, the restorations were evaluated by one evaluator using modified Ryge's criteria. After 2 years, 31 patients were examined. One Ceram.X-restoration had to be removed for root canal treatment due to pulpitis. Thus, failure rate of Ceram.X was 3.2% and of Tetric Ceram, 0%. In both groups, no sensitivity, no recurrent caries, and no changes in surface texture were recorded after 2 years. One restoration in each group showed slight changes in color stability (score B). Marginal discoloration (score B) was found concerning three Ceram.X-restorations (10.0%) and two Tetric Ceram-restoration (6.5%). Marginal integrity was score B for four Ceram.X-restorations (13.3%) and for four Tetric Ceram-restorations (12.9%). No statistically significant differences were found (p>0.05). After 2 years of clinical service, 96.8% of Ceram.X/K-0127 and 100% of Tetric Ceram/Syntac Classic restorations were in place and performed clinically well.

RCT Entities:   Population Interventions Outcomes