An interventional study of Digital Workflow Complete Denture and Hybrid Workflow Complete Denture in Complete Edentulism, sponsored by Universidad de Especialidades Espiritu Santo. Recruiting at 1 site in Ecuador. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Universidad de Especialidades Espiritu Santo · Not applicable, Interventional, and Treatment
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.
BACKGROUND Edentulism remains a significant public health concern, particularly among older adults, due to its impact on masticatory function, facial aesthetics, phonation, nutrition, and psychosocial well-being. Complete denture rehabilitation is the standard of care for edentulous patients; however, conventional fabrication techniques are associated with dimensional inaccuracies, multi-step laboratory procedures, and interoperator variability. The introduction of CAD-CAM systems and additive manufacturing (3D printing) offers potential advantages including improved precision, streamlined clinical workflows, and enhanced reproducibility. Despite growing clinical interest, robust evidence comparing digital and hybrid workflows - including patient-reported outcomes, clinical success, and objective functional measures such as masticatory force and denture wear - remains limited.
STUDY DESIGN Prospective, controlled, randomized, double-blind (participant and outcomes assessor), crossover clinical trial. No washout period between denture sets. Each participant receives two complete denture sets - one fabricated by digital workflow and one by hybrid workflow - in a randomized sequence. Total crossover phase: approximately 4 months per participant. Denture wear follow-up: 12 months from insertion of the second denture set.
PARTICIPANTS Completely edentulous adults aged 50-80 years requiring bimaxillary complete denture rehabilitation, attended at the UEES Dental Clinic. Recruitment is ongoing; first clinical appointments begin June 2026. Target sample: 28 participants (20 required for 83.7% power based on effect size d=1.25 from Peroz et al. 2024; 8 additional for anticipated dropout). Sample size calculated using G*Power 3.1, Wilcoxon-Mann-Whitney test, α=0.05, power=0.80.
INTERVENTIONS
Intervention A - Digital Workflow (3 clinical appointments):
Appointment 1: Intraoral scanning of edentulous ridges (TRIOS 5, 3Shape); digital recording of vertical dimension, intermaxillary relationship, and occlusal plane orientation.
Appointment 2: Clinical try-in of 3D-printed prototype (Asiga TRY resin, Asiga MAX 2 printer).
Appointment 3: Delivery of definitive 3D-printed complete denture (DentaBASE resin; VarseoSmile TriniQ teeth, BEGO).
Intervention B - Hybrid Workflow (5 clinical appointments):
Appointment 1: Preliminary impression and custom tray fabrication. Appointment 2: Functional impression with elastomeric materials. Appointment 3: Interocclusal registration (vertical dimension, centric relation, occlusal plane) with wax rims.
Appointment 4: Conventional wax try-in. Appointment 5: Delivery of definitive complete denture (conventionally impressed, digitally designed, additively manufactured base; DentaBASE resin; VarseoSmile TriniQ teeth, BEGO).
STUDY TIMELINE PER PARTICIPANT
Month 0: Insertion of Denture Set 1 (randomized: digital or hybrid) + baseline OHIP-EDENT + baseline T-Scan + baseline denture scan Month 2: 2-month control of Denture Set 1 + OHIP-EDENT + T-Scan + denture wear scan → Crossover: insertion of Denture Set 2 Month 4: 2-month control of Denture Set 2 + OHIP-EDENT (final crossover endpoint) + T-Scan + denture wear scan Months 4-16: Denture wear follow-up of Denture Set 2 at scheduled intervals (12-month longitudinal wear monitoring from insertion of Set 2)
RANDOMIZATION AND BLINDING Randomization sequences (A→B or B→A) generated by an external investigator using random.org. Concealed in sequentially numbered opaque sealed envelopes opened only after participant enrollment. The clinical operator cannot be blinded to the workflow; however, the participant and the outcomes assessor remain blinded throughout the study.
PRIMARY OUTCOME Oral health-related quality of life assessed by OHIP-EDENT total score at 4 time points across the crossover period.
SECONDARY OUTCOMES
Clinical success rate (composite: retention, stability, base adaptation, occlusal balance, need for adjustments) Maximum masticatory force (T-Scan; relative force and distribution) Denture wear - volumetric surface loss (mm³) via 3D STL superimposition over 12 months from Set 2 insertion Correlation between maximum masticatory force and denture wear
STATISTICAL ANALYSIS Normality assessed by Shapiro-Wilk test. Crossover comparisons (Obj. 1 and 2): paired t-test or Wilcoxon signed-rank test; categorical variables by McNemar's test; period and carryover effects evaluated. Longitudinal wear analysis (Obj. 8): repeated-measures ANOVA or Friedman test across time points; force-wear correlation by Pearson or Spearman coefficient. Significance: α=0.05. Missing data handled by intention-to-treat analysis where possible.
ETHICS Protocol approved by the Human Research Ethics Committee of Universidad de Especialidades Espíritu Santo (CEISH-UEES), Samborondón, Ecuador (March 2026). Conducted in accordance with the Declaration of Helsinki. Written informed consent obtained from all participants prior to enrollment.
Universidad de Especialidades Espiritu Santo is the lead sponsor of 10 studies on the registry; 7 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: 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)
Clinical Success Rate
Composite endpoint assessed by a calibrated blinded examiner using a standardized clinical form (adapted from Peroz et al.), including: denture base extension and border molding accuracy, bilateral balanced occlusion, retention by vertical traction test (good/moderate/deficient), stability during mandibular movements, phonetic evaluation (/s/, /z/, /f/), and need for clinical adjustments.
Time frame: At insertion, 2-month control of each denture set (Months 0, 2, and 4)
Maximum Masticatory Force
Relative occlusal force intensity and distribution recorded by the T-Scan digital occlusal analysis system (Tekscan Inc., Norwood, MA, USA) during maximum voluntary clenching. Parameters: total maximum force (relative units), right/left hemiarcade distribution, anterior/posterior distribution.
Time frame: 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
Volumetric loss (mm³) of occlusal surfaces quantified by 3D superimposition (best-fit alignment) of STL models obtained by intraoral or laboratory scanning. Baseline scan obtained at delivery of each denture set. Longitudinal monitoring of Set 2 wear conducted over 12 months from its insertion.
Time frame: 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
Pearson or Spearman correlation coefficient between T-Scan maximum force values and cumulative volumetric denture wear at each follow-up time point, for each workflow and overall.
Time frame: Assessed at each follow-up time point during the 12-month wear monitoring period (Month 2 through Month 14)
Plan to share: Yes — Individual participant data that underlie the results reported in the published article, after de-identification, will be shared.
Supporting information: 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.
Started Jul 2026 (actual). Primary completion is estimated for Nov 2026, 4 months after the start.
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Universidad de Especialidades Espiritu Santo