Department of Reconstructive Dentistry, University Center for Dental Medicine Basel, University of Basel, Basel, Switzerland.
Department of Prosthodontics and Dental Materials, School of Dental Medicine, University of Siena, Siena, Italy.
Clin Oral Implants Res. 2018 Sep;29(9):954-961. doi: 10.1111/clr.13360. Epub 2018 Aug 24.
The aim of this RCT was to analyze Patient Reported Outcome Measures (PROMs) of implant crowns processed in complete digital workflows (test) and combined analog-digital workflows (control) with a three-year follow-up. This is a second reporting from the same trial with sample size calculation based on time efficiency.
Twenty participants were selected for single-tooth replacement with screw-retained crowns in posterior sites (Straumann TL Implant System). Ten patients each were treated with test or control workflows and evaluated after 1 week of prosthetic delivery (baseline) and 3 years. The subjective opinion of the patient was assessed using visual analog scales (VAS) for PROMs; the Functional Implant Prosthodontic Score (FIPS) for the objective evaluation of the dentist. Wilcoxon signed-rank tests and Mann-Whitney U-tests were used for comparisons between test and control with a level of significance set at α = 0.05.
In test and control, implant crowns showed 100% survival without technical and/or biological complications. Mean PROMs varied between 81.6 and 90.3 with no difference between test and control, or between baseline and after 3 years for intra-patient comparison. Linear regression analysis exhibited a significant correlation between FIPS and PROMs related to overall treatment satisfaction (VAS-1: coefficient 0.45; p = 0.0472).
Subjective patient's perception (PROMs) of posterior implant crowns processed in complete digital and combined analog-digital workflows revealed comparable high levels of satisfaction on the overall treatment outcome including function, esthetics, and cleanability after 3 years. The objective evaluation of the dentist (FIPS) seems to reflect the perception of the patients.
本 RCT 的目的是分析在完全数字化工作流程（试验）和组合模拟-数字工作流程（对照）中处理的种植体冠的患者报告的结果测量（PROMs），并进行为期三年的随访。这是同一试验的第二次报告，样本量计算基于时间效率。
选择 20 名在后牙部位（Straumann TL 种植系统）进行单牙替换的患者，使用螺钉固位冠。每个患者各有 10 名接受试验或对照工作流程治疗，并在修复体交付后 1 周（基线）和 3 年后进行评估。使用视觉模拟量表（VAS）评估患者的主观意见，即 PROMs；使用功能性种植义齿修复评分（FIPS）评估牙医的客观评估。Wilcoxon 符号秩检验和 Mann-Whitney U 检验用于测试和对照之间的比较，显著性水平设置为 α=0.05。
在试验和对照中，种植体冠均无技术和/或生物学并发症，存活率为 100%。PROMs 的平均值在 81.6 到 90.3 之间，试验和对照之间、以及患者内比较的基线和 3 年后之间没有差异。线性回归分析显示，FIPS 与与整体治疗满意度相关的 PROMs 之间存在显著相关性（VAS-1：系数 0.45；p=0.0472）。
在后牙种植体冠的完全数字化和组合模拟-数字工作流程中处理的患者主观感知（PROMs）显示，在 3 年后的功能、美观和清洁性方面，患者对整体治疗效果的满意度相当高。牙医的客观评估（FIPS）似乎反映了患者的感知。
