Al-Salamony Hadeel, Akah Mai, Naguib Essam A, Safwat Omaima M
Department of Conservative Dentistry, Faculty of Dentistry, Cairo University; Department of Conservative Dentistry, Faculty of Oral and Dental Medicine, Future University, Cairo, Egypt, Phone: +201000604338, e-mail:
Department of Conservative Dentistry, Faculty of Dentistry, Cairo University, Cairo; Department of Conservative and Restorative Dentistry, Faculty of Dentistry, Galala University, Suez, Egypt, Orcid: https://orcid.org/0000-0003-2306-9169.
J Contemp Dent Pract. 2024 Dec 1;25(12):1127-1134. doi: 10.5005/jp-journals-10024-3787.
The balance between mechanical properties, esthetics, and therapeutic benefits in restorative materials, especially for high-risk patients, is lacking. Effective comparative study designs are required. This randomized clinical trial evaluated the clinical performance of Alkasite bioactive restorative material vs resin-modified glass ionomer (RMGI) in cervical carious lesions according to United States Public Health Service (USPHS) criteria over 1 year.
Twenty-eight high-risk adult patients with Class V cavities in anterior or premolar teeth were randomly assigned to two groups ( = 14 each). The first group received restorations with an RMGI. In contrast, using a selective etching technique and a universal adhesive, the second group was restored with a bulk-fill alkasite. All materials were applied according to the manufacturer's instructions. The restorations were evaluated at baseline (1 week), after 6 months, and after 12 months using modified USPHS criteria. Data were recorded and statistically analyzed.
Regarding the primary outcome of marginal integrity, no statistically significant difference was found between the alkasite and RMGI restorations at any follow-up interval. However, within the RMGI group, a statistically significant change in marginal integrity was observed across different follow-up periods. All secondary outcomes showed no statistically significant differences in either intragroup or intergroup comparisons at the various follow-up intervals, except for anatomic form, where a statistically significant difference was observed within the RMGI group over different follow-up periods.
Both restorations have shown similar clinical performance over a year, indicating their effectiveness in cervical restorations. Alkasite restoration can successfully replace RMGI for cervical restorations in patients with a high caries index.
This study addressed the need for restorative materials that balance mechanical strength, esthetics, and therapeutic benefits in high-risk patients. Alkasite restorations are promising alternatives to RMGI. The findings will guide material selection for enhanced functionality, esthetics, and long-term caries prevention.
NCT04716517. How to cite this article: Al-Salamony H, Akah M, Naguib EA, et al. Clinical Evaluation of Bulk-fill Alkasite Restoration vs Resin-modified Glass Ionomer in Class V Carious Lesions: 1-year Randomized Clinical Trial. J Contemp Dent Pract 2024;25(12):1127-1134.
修复材料在机械性能、美学效果和治疗益处之间的平衡尚不完善,尤其是对于高危患者而言。因此需要有效的对比研究设计。本随机临床试验根据美国公共卫生服务(USPHS)标准,对Alkasite生物活性修复材料与树脂改性玻璃离子体(RMGI)在治疗颈部龋损方面的临床性能进行了为期1年的评估。
28例在前牙或前磨牙患有V类洞的高危成年患者被随机分为两组(每组n = 14)。第一组使用RMGI进行修复。相比之下,第二组采用选择性酸蚀技术和通用粘结剂,使用大块充填Alkasite进行修复。所有材料均按照制造商的说明应用。使用改良的USPHS标准在基线(1周)、6个月后和12个月后对修复体进行评估。记录数据并进行统计分析。
关于边缘完整性的主要结果,在任何随访间隔中,Alkasite修复体和RMGI修复体之间均未发现统计学上的显著差异。然而,在RMGI组内,不同随访期的边缘完整性出现了统计学上的显著变化。除解剖形态外,所有次要结果在不同随访间隔的组内或组间比较中均未显示出统计学上的显著差异,而在RMGI组内,不同随访期的解剖形态存在统计学上的显著差异。
两种修复体在一年中的临床性能相似,表明它们在颈部修复中具有有效性。对于龋指数高的患者,Alkasite修复体可成功替代RMGI用于颈部修复。
本研究满足了高危患者对在机械强度、美学效果和治疗益处之间取得平衡的修复材料的需求。Alkasite修复体是RMGI的有前景的替代物。这些发现将指导材料选择,以增强功能、美学效果和长期防龋能力。
NCT04716517。如何引用本文:Al-Salamony H, Akah M, Naguib EA,等。大块充填Alkasite修复体与树脂改性玻璃离子体修复V类龋损的临床评估:1年随机临床试验。《当代牙科实践杂志》2024;25(12):1127 - 1134。