两种不同团状填充树脂复合修复材料的临床评估(随机临床试验)

N. A. Mahmoud, Rasha Saad Zaghlool Mohamed
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摘要

研究目的本研究旨在根据美国公共卫生署(USPHS)的修订标准,确定(Sonicfill 2)和(Fill Up)散装填充树脂复合材料的临床表现是否具有可比性。研究方法每位患者口腔的一侧相邻的两颗后牙分别接受两种类型的修复体(SonicFill 2)和(Fill Up)。在基线(1 周后)、6 个月、12 个月和 18 个月的随访期间,由两名经过校准的检查人员根据 Ryge 标准(修改后的 USPHS)对修复体的颜色匹配 (CM)、边缘适应 (MA)、边缘变色 (MD)、解剖形态 (AF) 和继发性龋齿 (SC) 进行评估。统计分析采用弗里德曼检验和威尔科克森检验,P 值低于 0.05 视为具有统计学意义。结果:两种批量填充树脂复合材料在基线和 6 个月后没有明显差异,100% 的修复体都获得了 Alpha (A) 分。在 18 个月后,60% 的(填充型)复合树脂修复体的 (A) 分数有所下降,并显示出 Bravo (B) 分数,在颜色匹配和解剖形态标准方面,两种修复体之间的差异具有统计学意义(p ≤ 0.05),而在其他评估标准方面,两种修复体都显示出 (A) 分数。结论在 18 个月的临床随访期内,作为 II 类龋洞的直接修复体,两种经测试的体填树脂复合修复材料均表现出令人满意的临床性能。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Clinical Evaluation of Two Different Bulk Fill Resin Composite Restorative Materials (A Randomized Clinical Trial)
Objective: This study aimed to determine whether the clinical performance of (Sonicfill 2) and (Fill Up) bulk fill resin composite is comparable according to the modified United State Public Health Service (USPHS) criteria. Methods: A total of 40 class II restorations were done following the manufacturer’s instructions, one side of each patient’s mouth received both types of restorations (SonicFill 2) and (Fill Up) in two adjacent posterior teeth. The restorations’ Color match (CM), Marginal adaptation (MA), Marginal discoloration (MD), Anatomic form (AF), and Secondary caries (SC) were evaluated based on Ryge’s criteria (modified USPHS) at baseline (after 1 week), as well as 6 month, 12 months, and after 18 months of follow-up by two calibrated examiners. The statistical analysis utilizing the Friedman and Wilcoxon tests, A p-value below 0.05 was deemed to be statistically significant. Results: There were no significant differences between the two types of bulk fill resin composite at baseline, and after six months, as 100% of both restorations had Alpha (A) score. Following 18-month period, 60% of (Fill Up) rein composite restorations displayed a decline in the (A) score and revealed Bravo (B) score regarding color match and anatomical form criteria, a statistically significant difference was observed between the two restorations (p ≤ 0.05), while in the other assessed criteria, both restorations displayed the (A) score. Conclusion: Within 18 months clinical follow up period, the two tested bulk-fill resin composite restorative materials exhibited satisfactory clinical performance as a direct restoration for class II cavity preparations.
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