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比较数字化和传统工作流程治疗后牙单单位种植修复体的患者报告结局测量(PROMs):一项随机对照试验。

Patient-reported outcome measures (PROMs) comparing digital and conventional workflows for treatment with posterior single-unit implant restorations: A randomized controlled trial.

机构信息

Department of Advanced General Dentistry, Mahidol University, Bangkok, Thailand.

Master of Science Program in Implant Dentistry, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.

出版信息

J Dent. 2022 Feb;117:103875. doi: 10.1016/j.jdent.2021.103875. Epub 2021 Oct 30.

DOI:10.1016/j.jdent.2021.103875
PMID:34728252
Abstract

OBJECTIVES

The aim of this randomized controlled trial (RCT) was to analyze patient-reported outcome measures (PROMs) of prosthetic therapy with monolithic implant crowns in completely digital workflows (test) with intraoral optical scanning (IOS) and conventional workflows (control) with conventional impressions. Secondary, an objective evaluation of the final implant restorations was performed using the Functional Implant Prosthodontic Score (FIPS).

MATERIALS AND METHODS

Forty patients who required an implant-supported single crown on posterior regions were randomly divided into test (n = 20) and control (n = 20) groups for impression taking. Each group was then equally separated into two subgroups according to the restorative material used: lithium disilicate (LS2, N!CE®, Straumann AG, Basel, Switzerland) or polymer-infiltrated ceramic networks (PICN, Enamic®, Vita, Bad Säckingen, Germany). Patient satisfaction was evaluated using PROM questionnaires with visual analog scales (VAS) after impression-taking and 1 week after prosthetic delivery. Patient satisfaction with the impression technique was assessed in six domains: length, comfort, anxiety, taste, nausea, and pain, whereas patient satisfaction with the final restoration was assessed in four domains: overall treatment outcome, functionality, esthetics, and cleanability. In addition, the final implant restorations were objectively assessed by an independent prosthodontist using the FIPS. Mann-Whitney U test was used to analyze the defined outcomes. Statistical analysis was completed with a level of significance set at α=0.05.

RESULTS

PROMs focusing on the impression technique demonstrated higher levels of patient satisfaction for IOS compared to conventional impressions, especially in terms of "taste irritation" (p = 0.036); whereas no significant differences were found between both restorative CAD/CAM-materials. Mean FIPS values demonstrated similar results among subgroups.

CONCLUSIONS

Within the limitation of this study, both completely digital and conventional protocols provided great levels of patient satisfaction in implant rehabilitation of single-tooth gaps in posterior sites with monolithic implant crowns. The restorative material, LS2 versus PICN, does not impact patient satisfaction with their treatment. However, a long-term follow up is needed to draw more specific conclusions on patient satisfaction with the restorations.

摘要

目的

本随机对照试验(RCT)旨在分析使用整体式种植体冠修复的患者报告的治疗结果(PROMs),并比较完全数字化工作流程(试验组,采用口内光学扫描(IOS))和传统工作流程(对照组,采用传统印模)下的 PROMs。此外,还使用功能性种植体修复体评分(FIPS)对最终种植体修复体进行客观评估。

材料和方法

40 名需要在后牙区进行种植体支持的单冠修复的患者随机分为试验组(n=20)和对照组(n=20),分别进行印模制取。然后,根据使用的修复材料将每组分为两组:锂硅玻璃陶瓷(LS2,N!CE®,Straumann AG,巴塞尔,瑞士)或聚合物渗透陶瓷网络(PICN,Enamic®,Vita,巴德沙伊克,德国)。在印模制取后和修复体交付后 1 周,使用视觉模拟量表(VAS)评估患者对 PROM 问卷的满意度。从 6 个方面评估患者对印模技术的满意度:长度、舒适度、焦虑、味觉、恶心和疼痛;从 4 个方面评估患者对最终修复体的满意度:总体治疗效果、功能、美观和清洁性。此外,由一名独立的修复医生使用 FIPS 对最终的种植体修复体进行客观评估。采用曼-惠特尼 U 检验对定义的结果进行分析。统计分析的显著性水平设为α=0.05。

结果

聚焦于印模技术的 PROMs 显示,与传统印模相比,IOS 获得了更高的患者满意度,尤其是在“味觉刺激”方面(p=0.036);而两种 CAD/CAM 修复材料之间无显著差异。亚组的平均 FIPS 值也显示出相似的结果。

结论

在本研究的限制范围内,对于后牙单牙间隙的整体式种植体冠修复,完全数字化和传统方案均能提供较高的患者满意度。修复材料(LS2 与 PICN)并不影响患者对治疗的满意度。然而,需要进行长期随访以得出关于患者对修复体满意度的更具体结论。

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