OBJECTIVES: This pilot study aims to evaluate monolithic digital complete dentures fabricated from shell-geometry two-colored Polymethylmethacrylate disks (Ivotion®, Ivoclar Vivadent AG). MATERIAL AND METHODS: The Biofunctional Prosthetic System (Ivoclar Vivadent AG) workflow was used for manufacturing complete upper and lower prostheses. The primary outcome was esthetic appearance, assessed by the accuracy of the pink-white resin transition and an esthetic score. Secondary outcomes included oral health-related quality of life (OHRQoL), denture satisfaction index (DSI), masticatory performance (MP), maximum bite force (MBF), bite pressure (BP) and prosthetic maintenance. Data analysis included descriptive statistics and multivariate comparison tests. The sample size was limited to ten participants. RESULTS: Three women and 7 men (mean age: 65 years) participated in the study; 9 completed the 3-month follow-up. Among the 20 prostheses, 8 presented imperfections of the white-pink transition (median: 1 mm; range: 0,3-10 mm). From 2 weeks onward, the novel dentures scored higher on the esthetic score than the previous dentures, which were considered ideal/near ideal (p<0.05). A non-significant improvement in OHRQoL, DSI and MP was noted whereas MBF and BP improved significantly over the observation period (p<0.05). Prosthodontic maintenance events included 2 small adjustments before the 2-week follow-up. CONCLUSION: The positive evaluations on esthetics with no or minor deviations in the transition from the white to the pink confirm the suitability of the design of the two-colored shell-geometry resin disk for CAD/CAM complete denture manufacturing. Furthermore, favorable patient-reported and clinical outcomes suggest that this novel system seems to be a viable treatment modality that warrants further investigation.
