CAD/CAM纳米混合复合材料与二硅酸锂制作的间接修复体用于残根活髓牙的两年临床性能：一项随机对照试验
Two‑year clinical performance of indirect restorations fabricated from CAD/CAM nano hybrid composite versus lithium disilicate in mutilated vital teeth. A randomized controlled trial.
作者信息
Elmoselhy Haneen Ahmad Shafik, Hassanien Olfat El Sayed, Haridy Mohamed Fouad, Salam El Baz Maha Abd El, Saber Shehabeldin
机构信息
Conservative Dentistry Department, Faculty of Dentistry, The British University in Egypt, Suez Desert Road El Sherouk City, Egypt.
Conservative Dentistry Department, Faculty of Dentistry, Cairo University, Giza, Egypt.
出版信息
BMC Oral Health. 2024 Jan 17;24(1):101. doi: 10.1186/s12903-023-03847-6.
TRIAL DESIGN
This is a randomized, controlled, superiority, double-blinded, parallel-group, two-arms trial with an allocation ratio of 1:1. The aim of this trial was to compare the two-year clinical performance of partial indirect restorations fabricated from CAD/CAM nano-hybrid composite and ceramic lithium disilicate blocks using the modified USPHS criteria.
METHODS
In two parallel groups (n = 50 restorations), fifty participants having mutilated vital teeth with a minimum of two remaining walls were randomly enrolled in this trial and received indirect restorations of either nano-hybrid composite resin blocks (Brilliant, Coltene, Switzerland) or Lithium Disilicate (IPS Emax CAD). The restorations were assessed using modified USPHS criteria by two independent blinded assessors at baseline, six months, one-year and two years follow-up visits. Categorical and ordinal data were presented as frequencies and percentages. Categorical data were analyzed using the chi-square test. Ordinal data were analyzed using the Mann-Whitney U test for intergroup comparisons and Freidman's test followed by the Nemenyi post hoc test for intragroup comparisons. Numerical data were presented as mean and standard deviation values. They were analyzed for normality using the Shapiro-Wilk test. Data were found to be normally distributed and were analyzed using the independent t-test. The significance level was set at p ≤ 0.05 within all tests.
RESULTS
Forty-eight participants received the allocated intervention and completed the follow-up periods. There was a statistically significant difference between both tested materials for all USPHS criteria regarding Marginal integrity and Marginal discoloration at six-months Follow-up, but with no statistically significant difference at one- and two-year follow-up.
CONCLUSIONS
Both materials showed an acceptable, successful clinical performance along the two-years follow-up period.
CLINICAL RELEVANCE
The CAD/CAM nano-hybrid composite blocks are as reliable as Lithium disilicate for restoring mutilated vital teeth.
试验设计
这是一项随机、对照、优效性、双盲、平行组双臂试验，分配比例为1:1。本试验的目的是使用改良的美国公共卫生服务（USPHS）标准，比较由CAD/CAM纳米混合复合材料和陶瓷二硅酸锂块制成的部分间接修复体的两年临床性能。
方法
在两个平行组（n = 50个修复体）中，50名有残损活髓牙且至少剩余两个牙壁的参与者被随机纳入本试验，并接受纳米混合复合树脂块（Brilliant，科尔tene，瑞士）或二硅酸锂（IPS Emax CAD）的间接修复体。在基线、六个月、一年和两年的随访中，由两名独立的盲法评估者使用改良的USPHS标准对修复体进行评估。分类和有序数据以频率和百分比表示。分类数据使用卡方检验进行分析。有序数据使用曼-惠特尼U检验进行组间比较，使用弗里德曼检验，随后进行内曼尼事后检验进行组内比较。数值数据以均值和标准差表示。使用夏皮罗-威尔克检验分析其正态性。发现数据呈正态分布，并使用独立t检验进行分析。所有检验的显著性水平设定为p≤0.05。
结果
48名参与者接受了分配的干预并完成了随访期。在六个月随访时，两种测试材料在所有USPHS标准的边缘完整性和边缘变色方面存在统计学显著差异，但在一年和两年随访时无统计学显著差异。
结论
在两年的随访期内，两种材料均显示出可接受的、成功的临床性能。
临床相关性
CAD/CAM纳米混合复合材料块在修复残损活髓牙方面与二硅酸锂一样可靠。
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