Oral health-related quality of life and patient satisfaction using three-dimensional printed dentures: A crossover randomized controlled trial

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ObjectivesThis 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. MethodsThis 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. ResultsBased 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). ConclusionsThis RCT revealed that CAD-3DP is comparable to CCD based on the OHIP-JDENT scores and patient satisfaction. Clinical SignificanceCAD-3DP is clinically applicable and comparable to CCD in terms of patient-reported outcomes.