NCT07626827 Clinical Performance and Quality of Life of 3D-Printed Complete Dentures Under Digital vs Hybrid Workflows: A Randomized Crossover Trial
| NCT ID | NCT07626827 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad de Especialidades Espiritu Santo |
| Condition | Complete Edentulism |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2026-11-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-07-01 with a primary completion date of 2026-11-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 the impact of complete denture treatment on OHRQoL using the validated OHIP-EDENT questionnaire, assessed at the insertion of each denture set and at the 2-month control of each period (4 measurement points total). To evaluate the relationship between maximum masticatory force (T-Scan digital occlusal analysis system) and denture wear (volumetric 3D digital metrology via STL superimposition), with wear monitored over 12 months from insertion of the second denture set.
Eligibility Criteria
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
Contact & Investigator
Pablo Benitez, PhD
STUDY DIRECTOR
Universidad de Especialidades Espiritu Santo
Frequently Asked Questions
Who can join the NCT07626827 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 90 Years, studying Complete Edentulism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07626827 currently recruiting?
Yes, NCT07626827 is actively recruiting participants. Contact the research team at pbenitez@uees.edu.ec for enrollment information.
Where is the NCT07626827 trial being conducted?
This trial is being conducted at Samborondón, Ecuador.
Who is sponsoring the NCT07626827 clinical trial?
NCT07626827 is sponsored by Universidad de Especialidades Espiritu Santo. The principal investigator is Pablo Benitez, PhD at Universidad de Especialidades Espiritu Santo. The trial plans to enroll 20 participants.