Two-year randomized clinical trial to evaluate the performance of posterior bulk-fill resin composite with ionic releasing restorative material

IF 4.8 2区医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE

Journal of dentistry Pub Date : 2025-06-13 DOI:10.1016/j.jdent.2025.105912

Ahmad Gamal Mohamed Raghip , John C. Comisi , Hamdi H. Hamama , Salah Hasab Mahmoud

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引用次数: 0

Abstract

Objectives

To compare the two-year clinical performance of a bioactive ionic resin restorative (Activa™ BioActive-Restorative™) with that of a conventional bulk-fill composite (Filtek™ One Bulk Fill Restorative) in Class I posterior restorations.

Methods

A randomized, double-blind, split-mouth clinical trial was conducted involving 22 patients (aged 25–55 years) who required the restoration of bilateral posterior teeth with ICDAS score five lesions. A total of 44 restorations were placed: 22 used Activa™ BioActive-Restorative™ (BIR) and 22 used Filtek™ One Bulk Fill Restorative (BFC). Cavity preparation included selective caries removal and selective enamel etching, followed by the application of adhesive. Clinical evaluations using modified FDI criteria were conducted at 3, 6, 12, and 24 months. Statistical analyses employed Chi-square, Fisher’s exact test, and Cochran’s tests.

Results

Both materials demonstrated excellent performance across all clinical parameters, with no failures or secondary caries reported over a 24-month period. No statistically significant differences were observed between groups at the 3-, 6-, or 12-month follow-ups. However, significant differences were identified at 24 months in surface luster, occlusal wear, anatomical form, and material fracture (p < 0.05), favoring the BIR group. Intra-group analysis also revealed significant changes over time in both groups.

Conclusions

When combined with an adhesive protocol, BIR exhibited performance similar to a traditional bulk-fill composite over two years, showing improved long-term stability in specific parameters. Its bioactive characteristics and excellent wear resistance position it as a strong alternative for posterior restorations.

Clinical significance

Bioactive restorative materials may enhance the long-term performance of posterior tooth restorations when used in conjunction with appropriate bonding techniques.

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评价离子释放修复材料后路块状填充树脂复合材料性能的两年随机临床试验。

目的：比较生物活性离子树脂修复体（Activa™bioactive - restorative™）与传统块状填充复合材料（Filtek™Z350XT）在I类后牙修复体中的两年临床表现。方法：采用随机、双盲、裂口临床试验方法，对22例需要修复双侧后牙，ICDAS评分为5个病变的患者（年龄25-55岁）进行研究。总共放置了44个修复体：22个使用Activa™BioActive-Restorative™（BIR）， 22个使用Filtek™Z350XT散装填充复合材料（BFC）。龋洞准备包括选择性除龋和选择性牙釉质蚀刻，然后应用粘合剂。使用修改后的FDI标准在3、6、12和24个月时进行临床评估。统计分析采用卡方检验、费雪精确检验和科克伦检验。结果：两种材料在所有临床参数中都表现出优异的性能，在24个月的时间里没有失败或继发性龋齿的报道。在3个月、6个月或12个月的随访中，各组之间没有统计学上的显著差异。然而，在24个月时，在表面光泽、咬合磨损、解剖形态和材料断裂方面发现了显著差异（p < 0.05），有利于BIR组。组内分析也揭示了两组随时间的显著变化。结论：当与粘合剂方案相结合时，BIR在两年内表现出与传统的大块填充复合材料相似的性能，在特定参数上表现出更好的长期稳定性。其生物活性特性和优异的耐磨性使其成为后路修复的有力替代品。临床意义：生物活性修复材料配合适当的粘接技术可提高后牙修复体的长期性能。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of dentistry 医学-牙科与口腔外科

CiteScore

7.30

自引率

11.40%

发文量

349

审稿时长

35 days

期刊介绍： The Journal of Dentistry has an open access mirror journal The Journal of Dentistry: X, sharing the same aims and scope, editorial team, submission system and rigorous peer review. The Journal of Dentistry is the leading international dental journal within the field of Restorative Dentistry. Placing an emphasis on publishing novel and high-quality research papers, the Journal aims to influence the practice of dentistry at clinician, research, industry and policy-maker level on an international basis. Topics covered include the management of dental disease, periodontology, endodontology, operative dentistry, fixed and removable prosthodontics, dental biomaterials science, long-term clinical trials including epidemiology and oral health, technology transfer of new scientific instrumentation or procedures, as well as clinically relevant oral biology and translational research. The Journal of Dentistry will publish original scientific research papers including short communications. It is also interested in publishing review articles and leaders in themed areas which will be linked to new scientific research. Conference proceedings are also welcome and expressions of interest should be communicated to the Editor.