CLINICAL IMPACT OF 3D PRINTED DENTURE: RANDOMIZED CLINICAL TRIAL
D Printing. CAD-CAM. Complete Denture. Patient satisfaction. Quality of Life.
Complete dentures (CDs) remain the standard treatment for edentulous patients with psychological/financial limitations, so that future perspectives strengthen the importance of improving manufacturing techniques. New digital resources have provided advances in the manufacture of complete dentures with promptness and quality, optimizing clinical time, reducing the number of visits to prosthetic rehabilitations, speeding up laboratory processing with reduced costs. Considering the advantages of additive manufacturing and the application of an abbreviated technique with the aid of a device, this study aimed to evaluate the clinical impact of rehabilitation with complete dentures by conventional technique and 3D printing digital workflow, considering patient-centered outcomes (PROMs), masticatory performance (MP), events after delivery, time-efficiency and cost-effectiveness. In this randomized crossover clinical trial, 30 completely edentulous were randomized into two groups according to the processing technique: GPC-GPI (initially rehabilitated with conventional CD and, after 3 months, with 3D-printed CD) and GPI-GPC (initially rehabilitated with 3D-printed CD and, after 3 months, with conventional CD). The impact of quality of life on oral health (OHRQoL) was measured using the OHIP-Edent-19, patient satisfaction using a validated questionnaire, and MP was assessed using an objective method, based on chewing gum with two colors (Vivident) within 3 months after the installation of each pair of dental prostheses. The occurrence of traumatic ulcers, mapping of occlusal contact points, need for occlusal/base adjustments or repairs and the time required for functional adaptation were collected over the 3 months of use of conventional CD and by digital workflow. The time for carrying out of the clinical and laboratory steps was recorded in the medical record and the cost-effectiveness analysis will be performed using the incremental cost-effectiveness ratio (ICER). Data normality will be determined using the Shapiro-Wilk test. Given the non-normality of the data, the non-parametric Mann-Whitney test and the Wilcoxon test will be used. The Chi-square test will be applied for analysis of dichotomous data. Statistical tests will be performed considering a significance level of 5% and test power of 80%. As a projected result, 3D-printed complete dentures will provide better clinical performance, it is a more satisfactory treatment option and better quality of life for patients, with greater time-efficiency and cost-effectiveness, and lower socioeconomic and environmental impacts.