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

RecruitingNAAges 50 Years - 90 YearsAllUniversidad de Especialidades Espiritu Santo
NCT07626827 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 a

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📋 Eligibility rules (as published)
Inclusion Criteria: * Completely edentulous (bimaxillary) * Age between 50 and 90 years * Able to understand and sign informed consent * No cognitive or psychological deficits that interfere with study participation Exclusion Criteria: * Unimaxillary edentulism * Presence of Kelly syndrome * Presence of flabby tissue on alveolar ridges * No prior experience with complete dentures * Chronic motor disorders that may compromise prosthetic function
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What it tests

  • Digital Workflow Complete Denture
  • Hybrid Workflow Complete Denture
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Where

1 site
Clínica Odontológica - Universidad de Especialidades Espíritu Santo (UEES)
Samborondón, Ecuador
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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