Performance of self-adhesive bulk-fill hybrid versus incremental resin composite in compound class II restorations: a one-year randomized clinical trial.

R. A. Abd ElAziz, Dina Kamal, Dina E. Ahmed
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Abstract

Aim : The aim of this randomized clinical trial was to assess the performance of a self-adhesive, bulk-fill hybrid (Surefil One TM , Dentsply Sirona, Konstanz, Germany) versus incremental, nanohybrid resin composite (Ceram.x® SphereTEC™ one Universal Nano-Ceramic Restorative, Dentsply Sirona, Konstanz, Germany) in restoring compound class II lesions over one-year follow up period. Materials and Methods: Sixty-two participants were randomly assigned to each group. All materials were placed upon manufacturer’s instructions. Restorations were assessed after 6-and 12-months intervals using the modified USPHS clinical criteria. Categorical data were analyzed using Fisher’s exact and McNemar’s tests for inter and intragroup comparisons respectively. Ordinal data were analyzed using Mann-Whitney U and Friedman’s test followed by Nemenyi post hoc test for inter and intragroup comparisons respectively. Survival analysis was done using Kaplan-Meier estimate and log-rank test. Results: Except for retention at 6 months, for all parameters and at both time intervals, there was a significant difference between the two groups with the control group having significantly higher percentage of cases with alpha score (p<0.05). For retention, surface roughness, recurrent caries, color match, anatomic form and proximal contact, there was a significant reduction in the percentage of cases with alpha score for the intervention group only after 12 months (p<0.05). Conclusion: Incremental, nanohybrid resin composite showed superior clinical performance than the self-adhesive, bulk-fill resin hybrid over one-year follow up.
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复合 II 级修复体中自粘散装填充混合材料与增量树脂复合材料的性能对比:为期一年的随机临床试验。
目的:本随机临床试验的目的是评估在一年的随访期内,自粘性、大量填充混合树脂(Surefil One TM,Dentsply Sirona公司,德国康斯坦茨)与增量纳米混合树脂复合材料(Ceram.x® SphereTEC™ one通用纳米陶瓷修复体,Dentsply Sirona公司,德国康斯坦茨)在修复复合II类病变方面的性能。材料和方法:62 名参与者被随机分配到每组。所有材料均按照生产商的说明使用。在 6 个月和 12 个月后,采用修改后的 USPHS 临床标准对修复效果进行评估。分类数据分别采用费雪精确检验和麦克尼马检验进行组间和组内比较分析。组间和组内比较分别采用 Mann-Whitney U 和 Friedman 检验,然后进行 Nemenyi post hoc 检验。生存期分析采用 Kaplan-Meier 估计和对数秩检验。结果除 6 个月的保留率外,两组在所有参数和两个时间间隔上均存在显著差异,对照组的阿尔法评分显著高于对照组(P<0.05)。在保持率、表面粗糙度、复发龋、颜色匹配、解剖形态和近端接触方面,干预组只有在 12 个月后出现阿尔法评分的病例比例才有显著下降(P<0.05)。结论在一年的随访中,增量纳米混合树脂复合材料的临床表现优于自粘树脂混合材料。
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