Abstract：
OBJECTIVE: This study aimed to evaluate the long-term clinical performance of Giomer and a self-etch adhesive system compared with a nanofilled resin composite and etch-and-rinse adhesive system in Class I and Class II restorations.
METHODS: The study was designed to be double-blinded with intra-individual control. 48 patients with 54 pairs of cavities (class I or class II) were recruited. Each pair of restorations was placed with either BEAUTIFIL II (BF) and FL-BOND II (FL) or Filtek Z350 (Z350) and Scotchbond Multi-Purpose (SMP). Clinical evaluation was performed at baseline, 6-month, 18-month, 4-year and 8-year after placement according to modified USPHS criteria. Kaplan-Meier survival analysis and log rank tests were performed (SPSS 20.0, IBM Corporation, US) to compare the survival probability of different restorations.A generalized linear mixed model (GLMM) was adopted to assess the performance of the materials. The McNemar test was used to show significant changes for all the evaluation criteria and difference between them.
RESULTS: At the eight-year recall, 32 patients with 67 restorations were present. There were twelve restorations in total recorded as failure due to loss of retention, restoration fracture, secondary caries, tooth fracture or endodontic treatment due to pulp necrosis. The survival probabilities and calculated annual failure rate(AFR) of BF and Z350 restorations at 8-year were 87.2 % vs 87.8 % and 1.6 % vs 1.5 % respectively with no significant difference (p > 0.05)between the two materials. Over the recall time range of eight years, decreased possibility of alpha rating was observed for retention, marginal adaptation, marginal staining and surface roughness for both materials (p < 0.05). Decreased possibility of alpha rating was observed for surface staining and secondary caries for Z350 (p < 0.05) and restoration fracture for BF (p < 0.05), respectively. Comparing the two restorative systems over eight years, no significant difference was seen for linear decline of the possibility of alpha rating for any of the criteria evaluated (p > 0.05).
CONCLUSIONS: Giomer material and the self-etch adhesive system had comparable clinical performance with nanofilled resin composite and etch-and-rinse adhesive system over the observation period of eight years.
METHODS: The study was designed to be double-blinded with intra-individual control. 48 patients with 54 pairs of cavities (class I or class II) were recruited. Each pair of restorations was placed with either BEAUTIFIL II (BF) and FL-BOND II (FL) or Filtek Z350 (Z350) and Scotchbond Multi-Purpose (SMP). Clinical evaluation was performed at baseline, 6-month, 18-month, 4-year and 8-year after placement according to modified USPHS criteria. Kaplan-Meier survival analysis and log rank tests were performed (SPSS 20.0, IBM Corporation, US) to compare the survival probability of different restorations.A generalized linear mixed model (GLMM) was adopted to assess the performance of the materials. The McNemar test was used to show significant changes for all the evaluation criteria and difference between them.
RESULTS: At the eight-year recall, 32 patients with 67 restorations were present. There were twelve restorations in total recorded as failure due to loss of retention, restoration fracture, secondary caries, tooth fracture or endodontic treatment due to pulp necrosis. The survival probabilities and calculated annual failure rate(AFR) of BF and Z350 restorations at 8-year were 87.2 % vs 87.8 % and 1.6 % vs 1.5 % respectively with no significant difference (p > 0.05)between the two materials. Over the recall time range of eight years, decreased possibility of alpha rating was observed for retention, marginal adaptation, marginal staining and surface roughness for both materials (p < 0.05). Decreased possibility of alpha rating was observed for surface staining and secondary caries for Z350 (p < 0.05) and restoration fracture for BF (p < 0.05), respectively. Comparing the two restorative systems over eight years, no significant difference was seen for linear decline of the possibility of alpha rating for any of the criteria evaluated (p > 0.05).
CONCLUSIONS: Giomer material and the self-etch adhesive system had comparable clinical performance with nanofilled resin composite and etch-and-rinse adhesive system over the observation period of eight years.
摘要：
目的：本研究旨在评估Giomer和自蚀刻粘合剂系统与纳米填充树脂复合材料和蚀刻和冲洗粘合剂系统在I类和II类修复体中的长期临床表现。
方法：该研究设计为具有个体内对照的双盲研究。招募了48名具有54对空洞（I类或II类）的患者。每对修复体都放置有BEAUTIFILII（BF）和FL-BONDII（FL）或FiltekZ350（Z350）和Scotchbond多用途（SMP）。在基线时进行临床评估，6个月,18个月,根据修改后的USPHS标准，安置后4年和8年。进行了Kaplan-Meier生存分析和对数秩检验(SPSS20.0，IBM公司，US)比较不同修复体的生存概率。采用广义线性混合模型（GLMM）来评估材料的性能。McNemar检验用于显示所有评价标准的显著变化和它们之间的差异。
结果：在八年的召回中，有32例患者，有67个修复体。由于保留力的丧失，总共有12个修复体被记录为失败，恢复骨折,继发性龋齿，牙髓坏死导致的牙齿骨折或牙髓治疗。BF和Z350修复体8年的生存概率和计算的年失败率（AFR）分别为87.2％和87.8％和1.6％和1.5％，两种材料之间没有显着差异（p>0.05）。在八年的召回时间范围内，观察到保留率的α评级可能性降低，边际适应，两种材料的边缘染色和表面粗糙度(p<0.05)。对于Z350的表面染色和继发性龋齿（p<0.05）和BF的修复骨折（p<0.05），观察到α等级的可能性降低，分别。比较两种恢复性制度八年来，对于所评估的任何标准,α等级可能性的线性下降均无显著差异(p>0.05).
结论：Giomer材料和自蚀刻粘合剂系统在8年的观察期内具有与纳米填充树脂复合材料和蚀刻和冲洗粘合剂系统相当的临床性能。
方法：该研究设计为具有个体内对照的双盲研究。招募了48名具有54对空洞（I类或II类）的患者。每对修复体都放置有BEAUTIFILII（BF）和FL-BONDII（FL）或FiltekZ350（Z350）和Scotchbond多用途（SMP）。在基线时进行临床评估，6个月,18个月,根据修改后的USPHS标准，安置后4年和8年。进行了Kaplan-Meier生存分析和对数秩检验(SPSS20.0，IBM公司，US)比较不同修复体的生存概率。采用广义线性混合模型（GLMM）来评估材料的性能。McNemar检验用于显示所有评价标准的显著变化和它们之间的差异。
结果：在八年的召回中，有32例患者，有67个修复体。由于保留力的丧失，总共有12个修复体被记录为失败，恢复骨折,继发性龋齿，牙髓坏死导致的牙齿骨折或牙髓治疗。BF和Z350修复体8年的生存概率和计算的年失败率（AFR）分别为87.2％和87.8％和1.6％和1.5％，两种材料之间没有显着差异（p>0.05）。在八年的召回时间范围内，观察到保留率的α评级可能性降低，边际适应，两种材料的边缘染色和表面粗糙度(p<0.05)。对于Z350的表面染色和继发性龋齿（p<0.05）和BF的修复骨折（p<0.05），观察到α等级的可能性降低，分别。比较两种恢复性制度八年来，对于所评估的任何标准,α等级可能性的线性下降均无显著差异(p>0.05).
结论：Giomer材料和自蚀刻粘合剂系统在8年的观察期内具有与纳米填充树脂复合材料和蚀刻和冲洗粘合剂系统相当的临床性能。
