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多模式粘结剂在非龋性颈部病变修复中的性能及成功率/保留率:随机临床试验一年期报告

Multi-Mode adhesives performance and success/retention rates in NCCLs restorations: randomised clinical trial one-year report.

作者信息

Manarte-Monteiro Patrícia, Domingues Joana, Teixeira Liliana, Gavinha Sandra, Manso Maria Conceição

机构信息

Department of Medical Sciences, Faculty of Health Sciences, University Fernando Pessoa, Porto, Portugal.

Biostatistics, Faculty of Health Sciences, UFP Energy, Environment and Health Research Unit (FP-ENAS), University Fernando Pessoa, Porto, Portugal.

出版信息

Biomater Investig Dent. 2019 Nov 6;6(1):43-53. doi: 10.1080/26415275.2019.1684199. eCollection 2019.

Abstract

Compare clinical performance and success/retention rates of two multi-mode (MM) adhesives, applied in self-etch (SE) or etch-and-rinse (ER) modes, with SE-all-in-one adhesive (SE/SE with enamel etching) in NCCL restorations at one-year follow-up. Prospective, double-blind RCT approved by the University Fernando Pessoa and the National-Clinical-Research-Ethics Committees (CEIC-20150305), ClinicalTrials.gov registered (NCT02698371), in 38 participants with 210 restorations (AdmiraFusion) randomly allocated to six groups (Adhesives_Adhesion mode), each with 35 restorations: G1-Control FuturabondDC_SE; G2-Control FuturabondDC_SE with enamel etching; G3-FuturabondU_ER; G4-FuturabondU_SE; G5-AdheseUniversal_ER; G6-AdheseUniversal_SE. Restorations evaluated at baseline and one-year by three calibrated examiners (ICC ≥0.952) using FDI criteria and statistical analysis with nonparametric tests (alpha = 0.05). At one-year recall 36 participants, 199 restorations were available for examination; five (2.5%) restorations (G1  = 2; G2, G3, G4  = 1) were lost due to retention ( > .05); G1 showed less satisfying marginal adaptation ( < .05) than G2 and MM adhesives groups, particularly G6. Overall success rates ( > .05) were: 93.9% (G1), 97.0% (G2; G3; G4) and 100.0% (G5; G6). MM adhesives (FuturabondU and AdheseUniversal) showed similar and acceptable performance/success rates but also better clinical outputs than the SE-all-in-one adhesive (FuturabondDC), particularly in SE mode. Success and retention rates were similar and not dependent on materials or adhesion modes.

摘要

在非龋性颈部病变(NCCL)修复体中,比较两种多模式(MM)粘合剂在自酸蚀(SE)或酸蚀冲洗(ER)模式下应用时与自酸蚀一体式粘合剂(SE/SE,伴有釉质酸蚀)的临床性能及成功率/保留率,随访一年。该前瞻性、双盲随机对照试验经费尔南多·佩索阿大学和国家临床研究伦理委员会(CEIC - 20150305)批准,已在ClinicalTrials.gov注册(NCT02698371)。38名参与者共210颗修复体(AdmiraFusion)被随机分配到六组(粘合剂 - 粘结模式),每组35颗修复体:G1 - 对照FuturabondDC_SE;G2 - 对照FuturabondDC_SE伴有釉质酸蚀;G3 - FuturabondU_ER;G4 - FuturabondU_SE;G5 - AdheseUniversal_ER;G6 - AdheseUniversal_SE。在基线和一年时,由三名经过校准的检查者(组内相关系数ICC≥0.952)使用FDI标准进行评估,并采用非参数检验进行统计分析(α = 0.05)。在一年的回访中,36名参与者的199颗修复体可供检查;五颗(2.5%)修复体(G1 = 2颗;G2、G3、G4各1颗)因固位问题丢失(P>0.05);G1的边缘适应性不如G2和MM粘合剂组,尤其是G6组(P<0.05)。总体成功率(P>0.05)分别为:93.9%(G1)、97.0%(G2、G3、G4)和100.0%(G5、G6)。MM粘合剂(FuturabondU和AdheseUniversal)表现出相似且可接受的性能/成功率,但临床效果也优于自酸蚀一体式粘合剂(FuturabondDC),尤其是在SE模式下。成功率和保留率相似,且不依赖于材料或粘结模式。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c108/6964776/8c6d6779b08c/IABO_A_1684199_F0001_B.jpg

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