Evaluation of a technique for rehabilitation with complete dentures using a digital workflow based on the use of a maxillomandibular registration device.
CAD-CAM; Printing; Three-Dimensional; Denture; Complete;
With advances in CAD-CAM systems, new digital resources have optimized the fabrication of complete dentures (CDs). A preliminary study led to the development of a device for recording maxillomandibular relations, enabling the fabrication of CDs using an abbreviated three-appointment clinical protocol. Initial results demonstrated good accuracy and reduced working time compared with the conventional technique. This study aims to validate the device through a multicenter randomized crossover clinical trial conducted at four research centers. Forty-eight completely edentulous bimaxillary patients will be randomized into two groups: RDD–RDC (digital rehabilitation using the Dentureasy device followed by conventional digital rehabilitation) and RDC–RDD (conventional digital rehabilitation followed by digital rehabilitation using the Dentureasy device). During prosthesis fabrication, clinical and laboratory time will be recorded to assess the device's effectiveness and reliability, supported by an operator-reported questionnaire. At the installation appointment, clinician-measured outcomes will be evaluated, including technical quality (Sato Score) and prosthesis quality. Additionally, staining analysis will be performed. After a 3-month adaptation period, patient-reported outcomes will be evaluated, including satisfaction, the impact of the prosthesis on daily activities, and masticatory efficiency using a chewing-gum test. Clinical performance outcomes such as retention force and internal adaptation will also be analyzed. A wash-out protocol will be applied between crossover phases to ensure the validity of the results, with follow-up and annual data collection over three years. Statistical analysis will include normality testing; paired t-tests will be used for normally distributed data, and the Wilcoxon test for non-normal data. Additionally, chi-square tests will be performed, adopting a significance level of 5% and a power of 80%