Digital Dentistry, Graduate school of Medical and Dental Science, Tokyo Medical and Dental University (TMDU), Tokyo, Japan.
Gerodontology and Oral Rehabilitation, Graduate school of Medical and Dental Science, Tokyo Medical and Dental University (TMDU), Tokyo, Japan.
J Dent. 2024 Nov;150:105338. doi: 10.1016/j.jdent.2024.105338. Epub 2024 Sep 10.
This crossover randomized controlled clinical trial (RCT) aimed to evaluate the clinical applicability of three-dimensional printed dentures (CAD-3DPs) by comparing two fabricated complete dentures, CAD-3DPs and conventional complete dentures (CCDs), and assess the non-inferiority of CAD-3DPs. The hypothesis was that CAD-3DPs would be inferior to CCDs in terms of the oral health-related quality of life (OHRQoL) and patient satisfaction.
This single-blind RCT was conducted at two university hospitals. The participants included adult patients with edentulous maxillary and mandibular arches, who had existing complete dentures and were willing to use new complete dentures. Eighteen participants were assigned to two groups: CCD-CAD-3DP and CAD-3DP-CCD, based on the order of denture delivery. Both sets of maxillary and mandibular CCDs and CAD-3DPs were delivered to all the participants. The OHRQoL using Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT-J) was considered the primary outcome. General satisfaction using a 100-mm visual analog scale was also evaluated as a suboutcome.
Based on the non-inferior test on the total score of the OHIP-EDENT and each score of the seven conceptual subdomains, the lower limit of the 95 % confidence interval was < 2.65 in seven domains. Therefore, CAD-3DP was judged to be non-inferior to CCD. Patient satisfaction was not significantly different between the CCD and CAD-3DP groups (p > 0.05).
This RCT revealed that CAD-3DP is comparable to CCD based on the OHIP-JDENT scores and patient satisfaction.
CAD-3DP is clinically applicable and comparable to CCD in terms of patient-reported outcomes.
本交叉随机对照临床试验（RCT）旨在通过比较两种制作的全口义齿（CAD-3DPs 和传统全口义齿 [CCDs]）来评估三维打印义齿（CAD-3DPs）的临床适用性，并评估 CAD-3DPs 的非劣效性。假设 CAD-3DPs 在口腔健康相关生活质量（OHRQoL）和患者满意度方面劣于 CCDs。
这项单盲 RCT 在两所大学医院进行。参与者包括上颌和下颌无牙弓的成年患者，他们有现有的全口义齿，并愿意使用新的全口义齿。根据义齿交付顺序，将 18 名参与者分为两组：CCD-CAD-3DP 和 CAD-3DP-CCD。两组上颌和下颌 CCD 和 CAD-3DP 均交付给所有参与者。使用无牙患者口腔健康影响简表（OHIP-EDENT-J）评估口腔健康相关生活质量（OHRQoL）作为主要结局。使用 100 毫米视觉模拟量表评估总体满意度作为次要结局。
根据 OHIP-EDENT 总分和七个概念子领域每个评分的非劣效性检验，七个领域的下限置信区间<2.65。因此，CAD-3DP 被判定为不劣于 CCD。CCD 组和 CAD-3DP 组患者满意度无显著差异（p>0.05）。
本 RCT 表明，根据 OHIP-JDENT 评分和患者满意度，CAD-3DP 与 CCD 相当。
CAD-3DP 在患者报告的结果方面具有临床适用性，并且与 CCD 相当。
