A Pilot Randomised Controlled Trial to Compare 3D Printed Versus Conventionally Fabricated Complete Dentures

Objectives: This pilot randomised controlled trial assessed the acceptability of 3D printed complete dentures versus conventionally manufactured dentures. It aimed to identify the sample size needed for a full-scale trial and refine digital fabrication and trial protocols. Methods: A multi-centre, double-blinded, cross-over design was used with 17 participants (14 completed), all aged 60+ and complete denture wearers. Each participant received 3D printed and conventional dentures, worn for eight weeks each. Tooth positioning and denture shape were standardised. The OHIP-EDENT questionnaire measured comfort, retention, stability, and chewing efficiency. Results: A sample size of 35 is recommended for a definitive trial. Participants preferred conventional dentures. Issues with 3D printed dentures included unreliable tooth placement and structural failures. Seven breakages (one denture broke four times) and six tooth debondings occured in the 3D printed group. Conclusions: A sample size of 35 participants is recommended for a definitive trial, post adjustment. 3D printing offers potential benefits, but this study found lower patient satisfaction and material challenges in the 3D printed dentures. Technical and protocol refinements are needed before 3D printed dentures can be recommended for routine use. Clinical Relevance: Until fabrication issues are resolved, conventional dentures remain the more reliable option in prosthodontic care.