3D-printed dentures using digital vs hybrid workflows in full-arch dentures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized crossover trial, adults 50–80 with complete edentulism receive two sets of dentures: one made with a digital workflow (direct intraoral scan, CAD design, 3D printing) and one with a hybrid workflow (digitized functional impressions, CAD design, 3D printing). Each participant uses each denture set for about 2 months in a randomized sequence, with no washout period, for a total follow-up of roughly 4 months per participant; a longer follow-up of 12 months after the second insertion assesses longer-term outcomes. The study aims to compare clinical performance and patient-reported oral health-related quality of life between the two fabrication methods. The trial is designed as prospective, controlled, randomized, double-blind for participants and outcome assessors, and conducted at UEES in Samborondón, Ecuador.

Why it matters

Who can join: the full rules

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

Where it's running

• Clínica Odontológica - Universidad de Especialidades Espíritu Santo (UEES)
  Samborondón, Guayas, Ecuador Recruiting

Study contacts

• Study coordinator: Pablo Benitez, phd
• Email: pbenitez@uees.edu.ec
• Phone: +593996516891

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.