Search

Objectives: 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., Methods: 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., Results: 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)., Conclusions: This RCT revealed that CAD-3DP is comparable to CCD based on the OHIP-JDENT scores and patient satisfaction., Clinical Significance: CAD-3DP is clinically applicable and comparable to CCD in terms of patient-reported outcomes., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Maiko Iwaki reports financial support was provided by Japanese Dental Science Federation. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper, (Copyright © 2024 Elsevier Ltd. All rights reserved.)