Prospective cohort pilot study of 2-visit CAD/CAM monolithic complete dentures and implant-retained overdentures: Clinical and patient-centered outcomes.

STATEMENT OF PROBLEM Presently, no studies have evaluated clinical outcomes or patient-centered outcomes for complete dentures fabricated with computer-aided design and computer aided manufacturing (CAD/CAM) technology. PURPOSE The purpose of this prospective cohort pilot study was to evaluate the clinical and patient-centered outcomes for CAD/CAM monolithic dentures fabricated in 2 visits. MATERIAL AND METHODS Twenty participants with an existing set of maxillary complete dentures opposing either mandibular complete dentures or implant-retained overdentures that required replacement were recruited in this study. A 2-visit duplicate denture protocol was used to fabricate 40 arches of monolithic dentures with CAD/CAM technology. A 100-mm visual analog scale (VAS) instrument was then used to record 12 outcomes at baseline and at 1-year follow-up. Predetermined values were assigned to grade the VAS rating of each outcome as favorable (70.1-100) and unfavorable (≤70). Favorable ratings were sub-divided as excellent (90.1-100), good (80.1-90), and fair (70.1-80). The clinical outcomes were evaluated independently by 2 experienced prosthodontists at baseline and at 1-year follow-up. Patients evaluated the corresponding patient-centered outcomes during the same time intervals. Additional descriptive variables were also recorded. Each clinical and patient-centered outcome was summarized by medians and ranges. Differences in all ratings recorded at baseline and at 1 year were tested by 1-sided sign test (α=.05). RESULTS Of 20 participants, 3 were lost to follow-up, and 3 were unsatisfied with the digital dentures and withdrew from the study. These 3 participants were considered treatment failures. Of the 14 remaining participants, 9 had implant-retained mandibular overdentures, and 5 had conventional mandibular complete dentures. For clinical outcomes, the 12 studied outcomes were favorably evaluated by the 2 prosthodontist judges at the 1-year follow-up. Evaluations showed minimal differences between baseline and 1 year. An average of 5 emails (0-11) per patient were sent to the laboratory technicians to communicate the improvisation the CAD design of the dentures. An average of 3.3 denture adjustments were needed after insertion (0-10) during the 1-year period. For patient-centered outcomes, median ratings of all 14 participants indicated each of the 12 studied outcomes was favorable at the 1-year recall. Statistically significant improvements in patient ratings from baseline to 1 year were observed for the absence of denture sore spots and treatment time to make the dentures (P<.05). Minor complications related to loss of retention, excessive wear of teeth and the need for additional visits were observed in 5 participants. No other adverse clinical outcomes related to the CAD/CAM dentures were noted in the 14 evaluated participants, and all dentures were intact and in good condition at the 1-year follow-up. CONCLUSIONS Clinical and patient-centered outcomes for CAD/CAM monolithic dentures fabricated using a 2-visit protocol were evaluated favorably at a 1-year follow-up. However, the proportion of excellent and good ratings for overall satisfaction and assessment was higher for patients than clinicians. A considerable amount of the clinician's time and effort was devoted to aiding in the digital process for the fabrication of CAD/CAM dentures.