Abstract：
Evaluating the clinical survival and quality parameters of class-II restorations using 3M™ FiltekTM Bulk Fill Posterior Restorative compared to 3M™ FiltekTM Supreme XTE Universal Restorative over a period of five years.
A longitudinal, randomized, prospective split-mouth study with 60 patients (29 female, 31 male; mean age 44 y; range 20-77 y) and a total of 120 load-bearing class II restorations (TEST: n=60 Filtek Bulk Fill Posterior Restorative; CONTROL: n=60 Filtek Supreme XTE Universal Restorative) was conducted. Clinical evaluation was performed by blinded evaluators according to FDI criteria. Kaplan-Meier method was used for survival analysis and an intergroup comparison (Mann-Whitney-U-Test) was carried out. A basic significance level of 0.05 was corrected by the Bonferroni method to account for multiple testing (significance after correction: p<0.00067).
The mean overall survival of restorations was 92% after 56.98±1.51 months in the TEST group (95 CI= 54.02;59.94) and 92% after 57.25±1.46 months (95 CI= 54.39; 60.12) in the CONTROL group (log-rank p=0.995). In total, four failures occurred in both TEST and CONTROL group during the observation period (mean annual failure rate: 1.6%). The most common reasons for failure were chipping-fractures, debonding, cracked-tooth-syndrome and recurrent decay. With regard to the FDI criteria, no significant differences between TEST and CONTROL material occurred for any of the evaluated variables. In the TEST group two restorations had to be repaired and two had to be replaced, in the CONTROL group four restorations had to be replaced.
Both materials showed acceptable clinical performance and survival during the 5-year observation period.
The use of a nanofilled bulk-fill composite proved to be an aesthetically, functionally and biologically satisfactory alternative in posterior dentition.
A longitudinal, randomized, prospective split-mouth study with 60 patients (29 female, 31 male; mean age 44 y; range 20-77 y) and a total of 120 load-bearing class II restorations (TEST: n=60 Filtek Bulk Fill Posterior Restorative; CONTROL: n=60 Filtek Supreme XTE Universal Restorative) was conducted. Clinical evaluation was performed by blinded evaluators according to FDI criteria. Kaplan-Meier method was used for survival analysis and an intergroup comparison (Mann-Whitney-U-Test) was carried out. A basic significance level of 0.05 was corrected by the Bonferroni method to account for multiple testing (significance after correction: p<0.00067).
The mean overall survival of restorations was 92% after 56.98±1.51 months in the TEST group (95 CI= 54.02;59.94) and 92% after 57.25±1.46 months (95 CI= 54.39; 60.12) in the CONTROL group (log-rank p=0.995). In total, four failures occurred in both TEST and CONTROL group during the observation period (mean annual failure rate: 1.6%). The most common reasons for failure were chipping-fractures, debonding, cracked-tooth-syndrome and recurrent decay. With regard to the FDI criteria, no significant differences between TEST and CONTROL material occurred for any of the evaluated variables. In the TEST group two restorations had to be repaired and two had to be replaced, in the CONTROL group four restorations had to be replaced.
Both materials showed acceptable clinical performance and survival during the 5-year observation period.
The use of a nanofilled bulk-fill composite proved to be an aesthetically, functionally and biologically satisfactory alternative in posterior dentition.
摘要：
目的：在五年的时间内，使用3M™FiltekTMBulkFill后部修复与3M™FiltekTMSupremeXTEUniversalRestorative进行比较，评估II类修复体的临床生存和质量参数。
方法：纵向，随机化，对60例患者进行的前瞻性裂口研究(29例女性，31名男性；平均年龄44岁；范围20-77岁），总共进行了120个承重的II类修复体（测试：n=60Filtek散装填充后修复体；控制：n=60FiltekSupremeXTE通用修复体）。根据FDI标准，由盲法评估者进行临床评估。使用Kaplan-Meier方法进行生存分析,并进行组间比较(Mann-Whitney-U-Test)。通过Bonferroni方法校正0.05的基本显著性水平以说明多重检验(校正后的显著性:p<0.00067)。
结果：试验组56.98±1.51个月后修复体的平均总生存率为92%（95CI=54.02；59.94），对照组57.25±1.46个月后为92%（95CI=54.39；60.12）（log-rankp=0.995）。总的来说,在观察期间,TEST组和对照组共发生4次失败(年平均失败率:1.6%).最常见的失败原因是碎裂骨折，脱粘,牙齿破裂综合征和反复腐烂。关于外国直接投资标准，对于任何评估的变量，测试和对照材料之间没有显着差异。在TEST组中，必须修复两个修复体，必须更换两个修复体，在对照组中，必须更换四个修复体。
结论：在5年的观察期内，两种材料均显示出可接受的临床表现和生存率。
结论：使用纳米填充的散装填充复合材料被证明是一种美学，后牙列功能和生物学上令人满意的替代方案。
方法：纵向，随机化，对60例患者进行的前瞻性裂口研究(29例女性，31名男性；平均年龄44岁；范围20-77岁），总共进行了120个承重的II类修复体（测试：n=60Filtek散装填充后修复体；控制：n=60FiltekSupremeXTE通用修复体）。根据FDI标准，由盲法评估者进行临床评估。使用Kaplan-Meier方法进行生存分析,并进行组间比较(Mann-Whitney-U-Test)。通过Bonferroni方法校正0.05的基本显著性水平以说明多重检验(校正后的显著性:p<0.00067)。
结果：试验组56.98±1.51个月后修复体的平均总生存率为92%（95CI=54.02；59.94），对照组57.25±1.46个月后为92%（95CI=54.39；60.12）（log-rankp=0.995）。总的来说,在观察期间,TEST组和对照组共发生4次失败(年平均失败率:1.6%).最常见的失败原因是碎裂骨折，脱粘,牙齿破裂综合征和反复腐烂。关于外国直接投资标准，对于任何评估的变量，测试和对照材料之间没有显着差异。在TEST组中，必须修复两个修复体，必须更换两个修复体，在对照组中，必须更换四个修复体。
结论：在5年的观察期内，两种材料均显示出可接受的临床表现和生存率。
结论：使用纳米填充的散装填充复合材料被证明是一种美学，后牙列功能和生物学上令人满意的替代方案。
