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

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.

Conditions

• Complete Edentulism

Interventions

DEVICE

Digital Workflow Complete Denture

Complete dentures fabricated using direct intraoral scanning of edentulous ridges (TRIOS 5, 3Shape), CAD design (3Shape Dental System), 3D-printed try-in prototype (Asiga TRY resin, Asiga MAX 2 printer), and definitive 3D-printed denture (DentaBASE resin; VarseoSmile TriniQ teeth, BEGO). Completed in 3 clinical appointments.

DEVICE

Hybrid Workflow Complete Denture

Complete dentures fabricated using conventional preliminary and functional impressions (elastomeric materials), interocclusal registration with wax rims, conventional wax try-in, digitization of the impression/master model via laboratory scanner, CAD design (3Shape Dental System), and additive manufacturing of the definitive denture base (DentaBASE resin; VarseoSmile TriniQ teeth, BEGO). Completed in 5 clinical appointments.

Sponsors & Collaborators

• Universidad de Especialidades Espiritu Santo

  lead OTHER

Principal Investigators

• Pablo Benitez, PhD · Universidad de Especialidades Espiritu Santo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

50 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2026-11-15

Completion

2027-11-30

Countries

• Ecuador

Study Locations