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Two-year clinical outcomes of three-dimensional printed complete dentures: A prospective multicenter study of
Maiko Iwaki1, Yo Akiyama2, Mariko Mukai2
1Digital Dentistry, Graduate School of Medical and Dental Sciences, Institute of Science Tokyo, Tokyo, Japan.
Objectives:
To evaluate 2-year cumulative success and survival rates, changes in oral health-related quality of life (OHRQoL), and patient satisfaction among edentulous patients who continued to wear complete dentures fabricated by three-dimensional (3D) printing (CAD-3DPs) after a crossover randomized controlled trial (RCT).
Methods:
Eighteen edentulous patients (36 dentures) wearing maxillary and mandibular CAD-3DPs after the RCT were prospectively followed. Events were denture fracture, repair, relining, or occlusal reconstruction (success rate) and discontinuation of use (survival rate). OHRQoL (total and seven subdomain scores) and patient satisfaction (visual analogue scale) were assessed at RCT conclusion (T0) and every 6 months up to 24 months (T4), and compared with T0.
Results:
Twenty-four dentures (12 patients) completed 2-year observation. In the success analysis, the only events were fractures of four maxillary dentures, all occurring within the first year; in the survival analysis, four dentures (two patients) were discontinued after maxillary fracture. Two-year cumulative success and survival rates were 88% and 87%, respectively. Palatal thickness of fractured dentures had been set at 2.0-2.1 mm, at the lower end of the design range (2.0-2.5 mm). No significant changes from T0 were detected in the OHRQoL total score, any of its seven subdomains, or patient satisfaction during follow-up.
Conclusions:
CAD-3DPs showed high 2-year success and survival rates, with maintained OHRQoL and patient satisfaction, and can be an effective prosthetic treatment option for edentulous patients.
Clinical Significance:
Two-year prospective data support the clinical applicability of 3D-printed complete dentures. All fractures occurred in maxillary dentures with a thin palatal thickness setting, suggesting that attention to the denture design may help prevent fracture.
Trial Registration:
UMIN000037947.