[Evaluation of clinical efficacy of a kind of digital complete denture]

To compare the clinical efficacy of a kind of complete dentures fabricated using computer aided design/computer aided manufacturing (CAD/CAM) workflow with that of the complete denture fabricated using conventional workflow.

Twenty edentulous patients were included in this prospective, single-blind, self-controlled clinical trial. Two pairs of complete dentures were fabricated for each participant: one using the functional suitable denture (FSD) system with CAD/CAM, and the other using conventional fabrication workflow. In the final delivery appointment, the conventional dentures worn by the participant for 3 months at first. Then the participant swapped to wear digital denture for another 3 months. The patients' satisfaction and oral health related quality of life (OHRQoL) were measured using the visual analogue scale (VAS) and oral health impact profile (OHIP-20E) at baseline, 2 weeks, 1 month, 2 months, and 3 months following denture delivery. In addition, the masticatory efficiency of each pair of dentures was measured after three months adaptation period for each type of dentures.

The VAS scores of the twenty patients in FSD denture group on general satisfaction, ease of cleaning, ability to speak, esthetics, stability and oral health status on these six domains were higher than that of conventional denture group 3 months after delivery. While the VAS cores in FSD denture group on comfort, ability to chew and ability to chew up were the same as those of conventional denture group. But there was no significant difference (P>0.05). The VAS score on each domain in FSD denture group was higher than that of conventional denture group 3 months after delivery, three domains of which reached statistical significance (P < 0.05), involving functional limitation, psychological discomfort and total. The masticatory performance of the FSD denture (1.20±0.54) was slightly higher than that for the conventional denture (1.16±0.53), but the difference did not reach statistical significance (P=0.691).

The clinical efficacy of the FSD complete denture is comparable to that of the conventional complete denture. As for patient satisfaction and oral health related quality of life, FSD dentures received comparable scores as conventional complete dentures did.