Alkasite 与纳米复合树脂修复儿童恒磨牙窝沟龋的临床效果比较：一项随机临床试验。
Clinical effectiveness of alkasite versus nanofilled resin composite in the restoration of occlusal carious lesions in permanent molar teeth of children: a randomized clinical trial.
机构信息
Department of Pediatric and Preventive Dentistry, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education, Light House Hill Road, Mangalore, Karnataka, 575001, India.
Department of Pediatric and Preventive Dentistry, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education, Manipal, India.
出版信息
Eur Arch Paediatr Dent. 2023 Jun;24(3):301-311. doi: 10.1007/s40368-023-00788-0. Epub 2023 Mar 22.
PURPOSE
To evaluate and compare the clinical effectiveness of alkasite with nanofilled resin composite restorations for occlusal caries lesions in permanent molar teeth of children, at one-year follow-up.
METHODS
In this randomized controlled clinical trial with parallel design, 38 children aged 7-13 years with occlusal caries lesions on 59 first permanent molars were randomly allocated into two groups, Group 1: Filtek™ Z350XT (nanocomposite) and Group 2: Cention N (alkasite resin composite). The restorations were evaluated at one year using the United States Public Health Service (USPHS) criteria. Data were analyzed using Chi-square or Fisher's exact test.
RESULTS
All restorations had either Alpha or Bravo scores at one-year follow-up. In Group 1, all restorations scored Alpha, while one restoration each (3.6%) in Group 2 scored Bravo for fracture and marginal adaptation. All restorations in both groups scored Alpha for retention, secondary caries, and post-operative sensitivity. For anatomic form, all restorations in Group 1 scored Alpha, while three (10.7%) restorations in Group 2 had Bravo scores. For marginal discolouration, three restorations in both groups scored Bravo (11.5% and 10.7%, respectively). For surface roughness, one restoration (3.8%) in Group 1 and three restorations in Group 2 (10.7%) scored Bravo. The comparative results between the two groups for all the variables in the USPHS criteria were not statistically significantly different.
CONCLUSIONS
The performances of the nanofilled composite and alkasite were clinically acceptable and comparable. Alkasite can be an alternative material for the restoration of occlusal caries lesions in permanent molars of children.
CLINICAL TRIAL REGISTRATION
The clinical trial was registered at Clinical Trials Registry-India (CTRI Reg no: CTRI/2020/12/029830 Dated: 15/12/2020).
目的
在为期一年的随访中，评估和比较 alkasite 与纳米复合树脂复合材料用于儿童恒牙窝沟龋损的临床效果。
方法
这是一项随机对照临床试验，采用平行设计，将 38 名 7-13 岁患有 59 颗第一恒磨牙窝沟龋损的儿童随机分为两组，组 1：Filtek™ Z350XT（纳米复合材料）和组 2：Cention N（alkasite 树脂复合材料）。使用美国公共卫生服务（USPHS）标准在一年时对修复体进行评估。使用卡方或 Fisher 确切检验对数据进行分析。
结果
所有修复体在一年随访时均为 Alpha 或 Bravo 评分。在组 1 中，所有修复体均为 Alpha 评分，而组 2 中每个修复体（3.6%）均为 Bravo 评分，出现了断裂和边缘适应性问题。两组所有修复体的保留、继发龋和术后敏感均为 Alpha 评分。解剖形态方面，组 1 的所有修复体均为 Alpha 评分，而组 2 的 3 个修复体（10.7%）为 Bravo 评分。对于边缘变色，两组均有 3 个修复体（11.5%和 10.7%）为 Bravo 评分。对于表面粗糙度，组 1 中有 1 个修复体（3.8%）和组 2 中有 3 个修复体（10.7%）为 Bravo 评分。在 USPHS 标准的所有变量中，两组之间的比较结果无统计学显著差异。
结论
纳米复合材料和 alkasite 的性能在临床上是可接受且相当的。Alkasite 可作为儿童恒牙窝沟龋损修复的替代材料。
临床试验注册
该临床试验在印度临床试验注册处（CTRI Reg no：CTRI/2020/12/029830，日期：2020 年 12 月 15 日）进行了注册。
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