Comparing 3D-Printed Complete Dentures Made by Digital and Hybrid Methods in Adults with Complete Tooth Loss A Randomized Crossover Study

What this Trial Is About

Researchers are evaluating and comparing the clinical performance and oral health-related quality of life of complete dentures made by two additive manufacturing workflowsdigital and hybridin adults with complete tooth loss attending a dental clinic in Ecuador. This prospective randomized crossover trial aims to assess denture success, patient quality of life, and the relationship between chewing force and denture wear. The study includes adults aged 50 to 90 who require bimaxillary complete dentures. Participants receive two sets of dentures in random order one made entirely through digital workflow involving intraoral scanning, CAD design, and 3D printing in three appointments the other made through a hybrid workflow combining conventional impressions, digitization, CAD, and 3D printing in five appointments. Each denture set is worn for two months without a washout period before crossing over to the other set. After the crossover phase about four months, participants are followed for an additional 12 months to monitor denture wear. During the study, participants undergo assessments including oral health quality of life questionnaires OHIP-EDENT at denture insertion and after two months of wear for each set, clinical evaluations of denture success, measurements of maximum chewing force using a digital occlusal analysis system, and 3D scans to monitor denture wear over time. The total participation time per person is approximately 16 months, with monitoring continuing 12 months after insertion of the second denture set to evaluate long-term outcomes.

Clinical Performance and Quality of Life of 3D-Printed Complete Dentures Under Digital vs Hybrid Workflows: A Randomized Crossover Trial