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严重磨耗牙患者直接/间接复合树脂修复体性能的随机对照临床试验

Randomized controlled trial on the performance of direct and indirect composite restorations in patients with severe tooth wear.

机构信息

Radboud University Medical Center, Radboud Institute for Health Sciences, Department of Dentistry, The Netherlands.

Radboud University Medical Center, Radboud Institute for Health Sciences, Department of Dentistry, The Netherlands.

出版信息

Dent Mater. 2021 Nov;37(11):1645-1654. doi: 10.1016/j.dental.2021.08.018. Epub 2021 Sep 6.

Abstract

OBJECTIVE

The study aimed to evaluate survival and failure behavior of Direct Composite Restorations (DRC) and Indirect Composite Restorations (ICR) on molars and anterior teeth, in a Randomized Controlled Trial (RCT).

METHODS

Patients with generalized severe tooth wear were included, and randomly assigned to one of 2 protocols: (1) DCR: All teeth were restored with directly applied micro-hybrid composite restorations (Clearfil AP-X, Kuraray) for load bearing areas and nano-hybrid composite restorations (IPS Empress Direct, Ivoclar Vivadent) for buccal veneers; (2) ICR: First molars were restored with indirect composite 'tabletop' restorations and maxillary anterior teeth were restored with indirect palatal veneer restorations (Clearfil Estenia C&B, cemented with Panavia F, Kuraray). Remaining teeth were restored directly. Restorations were evaluated after 3 years, focusing on clinical acceptability. Statistical analysis was performed using Kaplan Meier curves, Annual Failure Rates (AFRs), and univariate Cox regression analyses (p < 0.05).

RESULTS

41 patients (age: 36.6 ± 6.6y) were evaluated after 3 years (40.0 ± 2.2 m). 408 restorations on first molars and palatal veneers on maxillary anterior teeth were part of this RCT, with 220 DCRs and 188 ICRs. No differences in survival between treatment modality for palatal veneers for any failure criteria were found. Tabletop restorations on first molars showed a considerable higher failure rate for ICR compared to DCR (p = 0.026, HR: 3.37, 95%CI = 1.16-9.81).

SIGNIFICANCE

In this RCT, directly applied composite restorations showed superior behavior compared to the indirect composite restorations, when used in the molar region.

摘要

目的

本研究旨在通过随机对照试验(RCT)评估磨牙和前牙直接复合修复体(DRC)和间接复合修复体(ICR)的生存率和失败行为。

方法

纳入患有广泛严重牙齿磨损的患者,并随机分为以下 2 种方案之一:(1)DRC:所有牙齿均使用直接应用的微混合复合修复体(Clearfil AP-X,Kuraray)修复承重区和纳米混合复合修复体(IPS Empress Direct,Ivoclar Vivadent)修复颊面贴面;(2)ICR:第一磨牙采用间接复合“桌面”修复体修复,上颌前牙采用间接腭贴面修复体(Clearfil Estenia C&B,用 Panavia F 粘结,Kuraray)修复。其余牙齿直接修复。3 年后评估修复体,重点关注临床可接受性。采用 Kaplan-Meier 曲线、年失败率(AFR)和单变量 Cox 回归分析进行统计学分析(p<0.05)。

结果

3 年后对 41 名患者(年龄:36.6±6.6y)进行了评估(40.0±2.2m)。该 RCT 包括 408 个第一磨牙和上颌前牙腭贴面修复体,其中 DRC 220 个,ICR 188 个。在任何失败标准下,治疗方式对腭贴面的存活率均无差异。第一磨牙的桌面修复体显示 ICR 的失败率明显高于 DRC(p=0.026,HR:3.37,95%CI:1.16-9.81)。

意义

在这项 RCT 中,与间接复合修复体相比,直接应用复合修复体在磨牙区表现出更好的性能。

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