Department of Conservative Dentistry and Periodontology, University Hospital Regensburg, Regensburg, Germany.
Department of Conservative Dentistry and Periodontology, University Hospital Regensburg, Regensburg, Germany.
J Dent. 2022 Oct;125:104275. doi: 10.1016/j.jdent.2022.104275. Epub 2022 Aug 28.
This randomized prospective split-mouth study evaluated the clinical performance of a novel, tooth-colored, self-adhesive bulk-fill restorative (SABF, 3M) for restoration of class II cavities as compared to a conventional bulk-fill composite (Filtek One, 3M; FOBF) over 36 months. The null-hypothesis was that both materials perform equally regarding clinical success and performance according to the FDI clinical criteria and scoring system.
30 patients received one SABF and one FOBF restoration each. For FOBF, Scotchbond Universal (3M) was used as adhesive (self-etch mode), whereas SABF was applied without adhesive. Two blinded examiners evaluated the restorations at baseline, 24 and 36 months using FDI criteria. Data were analyzed non-parametrically (χ-tests; α=0.05).
29 patients were available for the 24- and 36-month examinations. Clinical success rate was 96.6% for both materials at 36-mo (one restoration failure due to secondary caries each). All other restorations revealed clinically acceptable FDI scores at all recalls. FOBF performed significantly better than SABF at all time points regarding surface lustre (p<0.001) and color match and translucency (p<0.001) and regarding marginal staining at 36-months (p=0.008). Marginal staining and marginal adaptation deteriorated significantly over time for both materials (both p<0.001).
The null-hypothesis could only partially be rejected. Both materials performed similarly regarding clinical success and performance within 36 months of clinical service, but SABF exhibited significantly inferior, but clinically fully acceptable esthetic properties as compared to FOBF. Both restorative materials showed clinically fully acceptable results over 36 months of clinical service and thus may be recommended for clinical use.
The novel tooth-colored self-adhesive bulk-fill restorative exhibited clinically fully acceptable results over 36 months of clinical service, similarly to a conventional bulk-fill restorative used with a universal adhesive, but with slight shortcomings in esthetic properties. Therefore, both restorative materials may be recommended for clinical use.
本随机前瞻性分口研究评估了一种新型牙色自粘接块状填充修复材料（SABF，3M）用于修复 II 类洞的临床性能，与传统块状填充复合材料（Filtek One，3M；FOBF）相比，随访时间为 36 个月。零假设是两种材料在根据 FDI 临床标准和评分系统评估的临床成功率和性能方面表现相同。
30 名患者每侧各接受 1 次 SABF 和 1 次 FOBF 修复。对于 FOBF，使用 Scotchbond Universal（3M）作为胶粘剂（自酸蚀模式），而 SABF 则不使用胶粘剂。两名盲法检查者在基线、24 个月和 36 个月时使用 FDI 标准评估修复体。数据采用非参数分析（χ检验；α=0.05）。
29 名患者完成了 24 个月和 36 个月的检查。36 个月时，两种材料的临床成功率均为 96.6%（各有 1 例修复失败归因于继发龋）。所有其他修复体在所有随访时均显示出可接受的 FDI 评分。FOBF 在所有时间点的表面光泽（p<0.001）、颜色匹配和半透明度（p<0.001）以及 36 个月时的边缘染色（p=0.008）方面的表现均显著优于 SABF。两种材料的边缘染色和边缘适应性随时间显著恶化（均 p<0.001）。
零假设只能部分被否定。两种材料在 36 个月的临床服务期内，在临床成功率和性能方面表现相似，但 SABF 的美学性能明显较差，但在临床上完全可接受。两种修复材料在 36 个月的临床服务期内均显示出完全可接受的结果，因此可推荐用于临床应用。
新型牙色自粘接块状填充修复体在 36 个月的临床服务期内表现出完全可接受的结果，与使用通用胶粘剂的传统块状填充修复体相似，但在美学性能方面略有不足。因此，两种修复材料均可推荐用于临床应用。
