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.

Functional properties of bone marrow-derived MSC-based engineered cartilage are unstable with very long-term in vitro culture.

The success of stem cell-based cartilage repair requires that the regenerate tissue reach a stable state. To investigate the long-term stability of tissue engineered cartilage constructs, we assessed the development of compressive mechanical properties of chondrocyte and mesenchymal stem cell (MSC)-laden three dimensional agarose constructs cultured in a well defined chondrogenic in vitro environment through 112 days. Consistent with previous reports, in the presence of TGF-ß, chondrocytes outperformed MSCs through day 56, under both free swelling and dynamic culture conditions, with MSC-laden constructs reaching a plateau in mechanical properties between days 28 and 56. Extending cultures through day 112 revealed that MSCs did not simply experience a lag in chondrogenesis, but rather that construct mechanical properties never matched those of chondrocyte-laden constructs. After 56 days, MSC-laden constructs underwent a marked reversal in their growth trajectory, with significant declines in glycosaminoglycan content and mechanical properties. Quantification of viability showed marked differences in cell health between chondrocytes and MSCs throughout the culture period, with MSC-laden construct cell viability falling to very low levels at these extended time points. These results were not dependent on the material environment, as similar findings were observed in a photocrosslinkable hyaluronic acid (HA) hydrogel system that is highly supportive of MSC chondrogenesis. These data suggest that, even within a controlled in vitro environment that is conducive to chondrogenesis, there may be an innate instability in the MSC phenotype that is independent of scaffold composition, and may ultimately limit their application in functional cartilage repair.