Department of Operative Dentistry and Periodontology, University School and Dental Hospital, Albert Ludwigs University, Hugstetter Strasse 55, Freiburg, Germany.
J Adhes Dent. 2009 Oct;11(5):399-404.
The aim of this prospective study was to evaluate the clinical performance of the restorative material Ceram.X in combination with an experimental one-bottle etch-and-rinse adhesive (K-0127).
A single operator placed two Class I or II restorations in molars of 43 patients. One molar was restored with Ceram.X/K-0127 (Dentsply DeTrey), the other one with Tetric Ceram/Syntac Classic (Ivoclar Vivadent). At baseline, after one, two, and four years the restorations were evaluated by a second dentist using modified Ryge's criteria. After four years, 27 patients were examined.
In one patient, both restorations (Class II) had to be removed for root canal treatment due to pulpitis. Another Class II Ceram.X restoration (3.8%; 4.3% [1 of 23] of Class II restorations) showed score C with regard to wear/anatomical form. Thus, the cumulative failure rate was 7.4% in the Ceram.X group (8.3% of Class II restorations [2 of 24]) and 3.7% in the Tetric Ceram group (4.2% of Class II restorations [1 of 24]). Furthermore, three restorations (11.5%) in each group showed score B for anatomical form and marginal integrity. Slight marginal discoloration (score B) was found at 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). No sensitivity, recurrent caries, or changes in surface texture were recorded after four years. No statistically significant differences were found between the two restorative materials (p > 0.05).
After four years of clinical service, 92.6% of Ceram.X/K-0127 and 96.3% of Tetric Ceram/Syntac Classic restorations performed clinically well.
本前瞻性研究旨在评估修复材料 Ceram.X 与一种实验性单瓶酸蚀-冲洗型黏合剂(K-0127)联合使用的临床性能。
一名操作者在 43 名患者的磨牙中放置了 2 个 I 类或 II 类修复体。一颗磨牙用 Ceram.X/K-0127(登士柏迪特瑞)修复,另一颗用 Tetric Ceram/Syntac Classic(义获嘉伟瓦登特)修复。在基线时、1 年、2 年和 4 年后,由第二位牙医使用改良 Ryge 标准进行评估。4 年后,对 27 名患者进行了检查。
由于牙髓炎,有 1 名患者(2 颗修复体均为 II 类)需要将这 2 颗修复体全部取出进行根管治疗。另一颗 Ceram.X 修复体(Class II,占 3.8%;Class II 修复体共 23 颗,占 4.3%)在磨耗/解剖形态方面评分为 C。因此,Ceram.X 组的累积失效率为 7.4%(Class II 修复体共 24 颗,2 颗失败),Tetric Ceram 组为 3.7%(Class II 修复体共 24 颗,1 颗失败)。此外,两组各有 3 颗修复体(Class II,各占 11.5%)在解剖形态和边缘完整性方面评分为 B。在 5 颗 Ceram.X 修复体(19.2%)和 4 颗 Tetric Ceram 修复体(15.4%)上发现轻微的边缘变色(评分为 B)。两组各有 2 颗修复体(7.7%)在颜色稳定性方面出现轻微变化(评分为 B)。4 年后未记录到任何敏感性、继发龋或表面质地变化。两种修复材料之间无统计学差异(p>0.05)。
经过 4 年的临床使用,92.6%的 Ceram.X/K-0127 和 96.3%的 Tetric Ceram/Syntac Classic 修复体临床效果良好。