Condition: Complete Edentulism · Sponsor: Universidad de Especialidades Espiritu Santo
This prospective randomized crossover clinical trial evaluates and compares the clinical performance and oral health-related quality of life (OHRQoL) of complete dentures fabricated through two additive manufacturing workflows - digital and hybrid - in edentulous patients attending the Dental Clinic of Universidad de Especialidades Espíritu Santo (UEES), Samborondón, Ecuador. In the digital workflow, complete dentures are fabricated using direct intraoral scanning of edentulous ridges, CAD design, and 3D printing. In the hybrid workflow, conventional functional impressions are digitized, followed by CAD design and additive manufacturing of the definitive dentures. Each eligible participant receives two complete denture sets in a randomized crossover sequence (no washout period): Denture Set 1 is worn for 2 months, after which the participant crosses over to Denture Set 2, worn for an additional 2 months. Total active follow-up per participant is approximately 4 months. Following completion of the crossover phase, denture wear is monitored longitudinally for 12 months from the insertion of the second denture set (total study duration approximately 16 months per participant). The study addresses three specific objectives: To determine the clinical success rate of complete dentures fabricated by additive manufacturing under digital and hybrid workflows, evaluating retention, stability, denture base adaptation, occlusal balance, and need for clinical adjustments. To evaluate…
This description comes directly from the study's public registry record.
Pablo Benitez, phd · +593996516891 · pbenitez@uees.edu.ec
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| Clínica Odontológica - Universidad de Especialidades Espíritu Santo (UEES) | Samborondón, Guayas, Ecuador | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07626827