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CAD-CAM 全口义齿:一项双盲、随机、交叉临床试验,评估铣削和 3D 打印义齿。

CAD-CAM complete removable dental prostheses: A double-blind, randomized, crossover clinical trial evaluating milled and 3D-printed dentures.

机构信息

Clinic of General, Special care, and Geriatric dentistry, Centre of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032 Zurich, Switzerland; Division of Gerodontology and Removable Prosthodontics, University Clinics of Dental Medicine, University of Geneva, Rue Michel-Servet 1, 1211 Geneva - 4, Switzerland.

Clinic of General, Special care, and Geriatric dentistry, Centre of Dental Medicine, University of Zurich, Plattenstrasse 11, 8032 Zurich, Switzerland.

出版信息

J Dent. 2021 Dec;115:103842. doi: 10.1016/j.jdent.2021.103842. Epub 2021 Oct 9.

Abstract

OBJECTIVE

This double-blind, randomized, crossover, clinical trial aimed to evaluate and compare the differences between milled and 3D-printed complete removable dental prostheses (CRDPs).

METHODS

Fifteen edentulous patients (men: n = 10, women: n = 5; age: 66.7 ± 8.0 years) rehabilitated with conventional CRDPs were recruited for this trial. Participants were randomized to first receiving either the milled or 3D-printed CAD-CAM manufactured CRDPs and then after 6-weeks cross over to the other set. Both, clinicians and participants were blinded to the group allocation. Outcomes included patient's denture satisfaction (PDS), oral-health related quality of life (OHIP-EDENT), willingness-to-pay analysis, final choice (FC) of CRDPs, clinician's denture quality evaluation (CDQE), chewing efficiency (CE), maximum-voluntary-bite-force (MBF), and prosthodontic maintenance needs. The outcomes were measured at baseline (with old CRDPs), at 1 and 6 weeks after new CRDP insertion; following crossover with the second set of CRDPs, an identical protocol was followed. Generalized linear regression for repeated measures was used for statistical analysis with α=0.05.

RESULTS

All participants completed the trial. 3D-printed CRDPs required more maintenance visits, adjustment time (p = 0.0003), and adjustment costs (p = 0.021). Patients were willing-to-pay an average of 606.67 Swiss Francs more than the actual cost for the milled CRDPs. There were no differences in the PDS, OHIP, FC, CDQE, CE, and MBF between the two CRDPs groups.

CONCLUSIONS

The findings of this double-blind randomized crossover clinical trial confirm that both milled and 3D-printed CRDPs are valid treatment modalities for edentulous patients, with the latter performing inferiorly with regard to the time and costs involved with the prosthodontic aftercare, as well as the patients' willingness-to-pay.

CLINICAL RELEVANCE

The findings of this trial provide evidence to help the clinician in choosing the appropriate CAD-CAM manufacturing process for fabricating the CRDPs.

摘要

目的

本双盲、随机、交叉临床试验旨在评估和比较铣削和 3D 打印全口义齿(CRDP)之间的差异。

方法

本试验招募了 15 名接受传统 CRDP 修复的无牙颌患者(男性:n=10,女性:n=5;年龄:66.7±8.0 岁)。参与者被随机分为先接受铣削或 3D 打印 CAD-CAM 制造的 CRDP,然后在 6 周后交叉到另一组。临床医生和参与者均对分组情况不知情。结果包括患者义齿满意度(PDS)、口腔健康相关生活质量(OHIP-EDENT)、支付意愿分析、CRDP 最终选择(FC)、临床医生义齿质量评估(CDQE)、咀嚼效率(CE)、最大自愿咬合力(MBF)和修复体维护需求。结果在基线(使用旧 CRDP)、新 CRDP 插入后 1 周和 6 周以及使用第二套 CRDP 交叉后进行测量;遵循相同的方案。使用重复测量的广义线性回归进行统计分析,α=0.05。

结果

所有参与者均完成了试验。3D 打印 CRDP 需要更多的维护就诊、调整时间(p=0.0003)和调整费用(p=0.021)。患者愿意为铣削 CRDP 支付平均 606.67 瑞士法郎的额外费用。两组 CRDP 之间在 PDS、OHIP、FC、CDQE、CE 和 MBF 方面没有差异。

结论

这项双盲随机交叉临床试验的结果证实,铣削和 3D 打印 CRDP 都是无牙颌患者的有效治疗方法,后者在义齿修复后的时间和成本以及患者的支付意愿方面表现较差。

临床相关性

本试验的结果为临床医生选择合适的 CAD-CAM 制造工艺制作 CRDP 提供了证据。

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