Conservative Dentistry Department, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.
J Esthet Restor Dent. 2024 Sep;36(9):1311-1325. doi: 10.1111/jerd.13242. Epub 2024 Apr 24.
This randomized controlled clinical trial compared the clinical efficacy of self-adhesive bulk-fill Surefil One with a traditional bulk-fill composite in class II restorations.
Sixty-four direct class II composite restorations were categorized into two groups. Group I, control group (n = 32): cavities were restored by Filtek One bulk-fill composite with Scotchbond Universal (SBU) adhesive in self-etch mode, Group II, test group (n = 32): cavities were restored by Surefil One self-adhesive bulk-fill composite. The study involved a follow-up period of 1 year, during which restorations were assessed at baseline (BL), 6 months, and 12 months using Federation Dentaire Internationale (FDI) criteria. Data analysis was performed using nonparametric tests. A comparison of restoration characteristics was performed utilizing the chi-square test (X). The significance level was set at 0.05.
Filtek One and Surefil One bulk-fill composites revealed clinically acceptable FDI scores over 12-month recalls. Thirty-two patients (64 restorations) were available for all follow-up visits; 100% of the restorations survived. For esthetic properties, Filtek One was far better than Surefil One at all time points. However, in terms of functional and biological properties, both restorations demonstrated comparable performances.
Filtek One bulk-fill restorations were superior in terms of surface luster, surface staining, color match, and translucency, but Surefil One restorations performed well and were similar to Filtek One restorations; however, additional advancements and research are needed to obtain better esthetics. Furthermore, longitudinal studies with extended follow-up periods are needed to assess the clinical potential of both materials.
Both Filtek One and Surefil One met the FDI criteria, with Filtek One demonstrating superior esthetic and functional qualities and similar performance regarding biological criteria. Both innovative restorative materials show potential for clinical use. Trial registered on ClinicalTrials.gov under registration number; NCT06120868:07/11/2023.
本随机对照临床试验比较了自粘接块状充填 Surefil One 与传统块状充填复合材料在 II 类修复中的临床疗效。
将 64 个直接 II 类复合修复体分为两组。I 组，对照组（n=32）：使用 Scotchbond Universal（SBU）自酸蚀粘结剂在 Filtek One 块状充填复合树脂中进行窝洞修复；II 组，试验组（n=32）：使用 Surefil One 自粘接块状充填复合树脂进行窝洞修复。研究随访期为 1 年，在基线（BL）、6 个月和 12 个月时使用国际牙科联合会（FDI）标准评估修复体。采用非参数检验进行数据分析。采用卡方检验（X）比较修复体特征。显著性水平设定为 0.05。
Filtek One 和 Surefil One 块状充填复合材料在 12 个月的随访中均显示出可接受的 FDI 评分。32 名患者（64 个修复体）均完成所有随访；100%的修复体存活。在美学性能方面，Filtek One 在所有时间点均明显优于 Surefil One。然而，在功能和生物学性能方面，两种修复体的表现相当。
Filtek One 块状充填修复体在表面光泽度、表面染色、颜色匹配和半透明度方面表现更好，但 Surefil One 修复体表现良好，与 Filtek One 修复体相似；然而，需要进一步的改进和研究，以获得更好的美观效果。此外，需要进行具有更长随访期的纵向研究，以评估这两种材料的临床潜力。
Filtek One 和 Surefil One 均符合 FDI 标准，Filtek One 在美学和功能方面具有更好的质量，在生物学方面的性能相似。这两种创新性的修复材料均具有临床应用潜力。该试验在 ClinicalTrials.gov 上注册，注册号为 NCT06120868：2023 年 7 月 11 日。
