El-Salamouny Nada A, Elmahy Waleed A, Holiel Ahmed A
Conservative Dentistry Department, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.
Odontology. 2025 Apr 15. doi: 10.1007/s10266-025-01095-4.
This study evaluated the one-year clinical performance of Cention N, a new alkasite bioactive restorative material, compared to a conventional bulk-fill composite resin in 12 patients aged 18-45 years with class I cavities. The patients were randomly assigned to three groups: Group I (Cention N without adhesive), Group II (Cention N with adhesive), and Group III (Filtek Bulk Fill composite resin). The restorations were monitored at baseline, three, six, and twelve months using the FDI criteria, assessing marginal staining, recurrent caries, and postoperative sensitivity. Statistical analysis was performed using the Monte Carlo correction, chi-square test, and Friedman's test (p ≤ 0.05). The results showed clinically acceptable FDI scores for all restorations at each time interval with no significant differences between the groups (p ≥ 0.05). However, Cention N without adhesive demonstrated slightly inferior outcomes in postoperative sensitivity and marginal staining at the six- and twelve-month intervals. Overall, both materials performed similarly in terms of clinical performance within the first year, though Cention N without adhesive showed marginally lower, but still acceptable, results.Trial registration: ClinicalTrials.gov NCT06273410: 13/10/2022.
本研究评估了新型碱硅生物活性修复材料Cention N与传统大块充填复合树脂相比，在12例年龄在18至45岁、患有I类洞的患者中的一年临床性能。患者被随机分为三组：第一组（无粘结剂的Cention N）、第二组（有粘结剂的Cention N）和第三组（Filtek Bulk Fill复合树脂）。使用FDI标准在基线、3个月、6个月和12个月时对修复体进行监测，评估边缘染色、继发龋和术后敏感性。采用蒙特卡罗校正、卡方检验和弗里德曼检验进行统计分析（p≤0.05）。结果显示，在每个时间间隔，所有修复体的FDI评分在临床上均可接受，组间无显著差异（p≥0.05）。然而，无粘结剂的Cention N在6个月和12个月时的术后敏感性和边缘染色方面表现略差。总体而言，两种材料在第一年的临床性能方面表现相似，尽管无粘结剂的Cention N的结果略低，但仍可接受。试验注册：ClinicalTrials.gov NCT06273410：2022年10月13日。
