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

NCT07626827 | Recruiting DMC

• 2 other identifiers: 09226342740991275878001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Complete Edentulism

Keywords

hybrid workflow; complete denture; digital workflow; complete edentulous

Outcome Measures

Primary Outcomes (1)

• Oral Health-Related Quality of Life - OHIP-EDENT Total Score

  19-item validated questionnaire (Allen \& Locker, 2002). Each item scored 0 (never) to 4 (very often). Higher scores indicate worse OHRQoL. Assessed at 4 time points across the full crossover period to capture quality of life evolution under each workflow.

  t insertion of Denture Set 1 (Month 0); at 2-month control of Set 1 / insertion of Set 2 (Month 2); at insertion of Set 2 (Month 2); at 2-month control of Set 2 (Month 4)

Secondary Outcomes (4)

• Clinical Success Rate

  At insertion, 2-month control of each denture set (Months 0, 2, and 4)

• Maximum Masticatory Force

  At insertion, 2-month control of each denture set (Months 0, 2, and 4); additionally at follow-up intervals during 12-month wear monitoring (from Month 2 / Set 2 insertion)

• Denture Wear - Volumetric Surface Loss

  Baseline (Month 2, Set 2 insertion); follow-up scans at scheduled intervals through Month 14 (12 months from Set 2 insertion)

• Correlation Between Maximum Masticatory Force and Denture Wear

  Assessed at each follow-up time point during the 12-month wear monitoring period (Month 2 through Month 14)

Study Arms (2)

digital workflow

EXPERIMENTAL

Participants receive complete dentures fabricated by digital workflow first (intraoral scanning + CAD + 3D printing, 3 appointments), worn for 2 months, then cross over to hybrid workflow dentures for an additional 2 months.

Device: Digital Workflow Complete Denture

Hybrid Workflow

ACTIVE COMPARATOR

Participants receive complete dentures fabricated by hybrid workflow first (conventional impressions + digitization + CAD + 3D printing, 5 appointments), worn for 2 months, then cross over to digital workflow dentures for an additional 2 months.

Device: Hybrid Workflow Complete Denture

Interventions

Digital Workflow Complete Denture DEVICE

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.

digital workflow

Hybrid Workflow Complete Denture DEVICE

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.

Hybrid Workflow

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Especialidades Espiritu Santo: lead

Study Sites (1)

Clínica Odontológica - Universidad de Especialidades Espíritu Santo (UEES)

Samborondón, Guayas, Ecuador

RECRUITING

Related Publications (6)

• Garcia-Zea E, Revilla-Leon M. Digital workflow for fabricating printed complete dentures by integrating the true horizontal plane for articulator mounting and virtual patient integration. J Prosthet Dent. 2026 May;135(5):927-932. doi: 10.1016/j.prosdent.2025.09.018. Epub 2025 Oct 9.

  PMID: 41073152 BACKGROUND

• Garcia Zea E, Ullauri A, Benitez Sellan PL. Optimizing Complete Denture Fabrication With a Hybrid Analog-Digital Workflow: A Case Report. Case Rep Dent. 2025 Oct 3;2025:6761654. doi: 10.1155/crid/6761654. eCollection 2025.

  PMID: 41078965 BACKGROUND

• Revilla-Leon M, Ozcan M. Additive Manufacturing Technologies Used for Processing Polymers: Current Status and Potential Application in Prosthetic Dentistry. J Prosthodont. 2019 Feb;28(2):146-158. doi: 10.1111/jopr.12801. Epub 2018 Apr 22.

  PMID: 29682823 BACKGROUND

• Joda T, Zarone F, Ferrari M. The complete digital workflow in fixed prosthodontics: a systematic review. BMC Oral Health. 2017 Sep 19;17(1):124. doi: 10.1186/s12903-017-0415-0.

  PMID: 28927393 BACKGROUND

• Fenlon MR, Sherriff M. Investigation of new complete denture quality and patients' satisfaction with and use of dentures after two years. J Dent. 2004 May;32(4):327-33. doi: 10.1016/j.jdent.2004.01.007.

  PMID: 15053917 BACKGROUND

• Emami E, de Souza RF, Kabawat M, Feine JS. The impact of edentulism on oral and general health. Int J Dent. 2013;2013:498305. doi: 10.1155/2013/498305. Epub 2013 May 8.

  PMID: 23737789 BACKGROUND

Study Officials

• Pablo Benitez, PhD

  Universidad de Especialidades Espiritu Santo

  STUDY DIRECTOR

Central Study Contacts

Pablo Benitez, phd

CONTACT

+593996516891; pbenitez@uees.edu.ec

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Model Details: Crossover Assignment

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 4, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months after article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. Requests should be directed to the principal investigator.

Locations

EC (1)