Skip to content

Influence of Digital Workflows on Maxillary Complete Denture Base Accuracy

Influence of Digital Workflows on Maxillary Complete Denture Base Accuracy: A Prospective Clinical 3D Evaluation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07795983
Acronym
DigitalTech
Enrollment
13
Registered
2026-08-31
Start date
2024-03-12
Completion date
2026-01-05
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Denture, Complete, Removable Total Denture, Total Edentulism

Keywords

Digital denture, Fit accuracy, 3D printing, Intraoral scanning

Brief summary

Study Summary for Patients This research was carried out at Istanbul University to compare different ways of making upper denture bases. The goal was to see how well each method fits the mouth. Who participated? Thirteen completely edentulous patients (mean age 58 ± 3 years; 7 males, 6 females) were recruited at the Department of Prosthodontics, Istanbul University. All participants provided written informed consent, and ethical approval was obtained in accordance with the Declaration of Helsinki. What was tested? The study tested the fit accuracy of maxillary complete denture bases fabricated through four distinct clinical workflows-conventional, fully digital, hybrid early, and hybrid late. Each patient received four maxillary denture bases fabricated through distinct workflows: Conventional (C): Traditional impression and compression molding technique. Fully Digital (FD): Intraoral scanning, CAD design, and 3D printing. Hybrid Early (HE): Digitally designed custom tray followed by conventional impression and fabrication. Hybrid Late (HL): Conventional impression, cast scanning, CAD design, and 3D printing. How was fit checked? All denture bases were scanned with a high-resolution industrial scanner. Their intaglio surfaces were superimposed onto the corresponding master cast scans using specialized software. Fit accuracy was assessed at 22 predefined anatomical points across six regions (alveolar ridge crest, palate, anterior and lateral border seals, posterior palatal seal, and bilateral tuberosities). This methodology enabled both overall and region-specific evaluation of adaptation. Why is this important? Accurate denture base fit is essential for patient comfort, stability, and functional performance. By systematically comparing conventional and digital workflows, this study provides evidence on which fabrication approach yields superior adaptation, thereby guiding clinicians toward more predictable and patient-centered prosthodontic outcomes.

Detailed description

The patient registry was organized as a prospective randomized controlled clinical study conducted at the Department of Prosthodontics, Istanbul University, between March 2024 and March 2025. Ethical approval was obtained from the Institutional Review Board (TDK-2024-2476686), and all participants signed written informed consent in accordance with the Declaration of Helsinki. A priori power analysis determined the minimum sample size, and thirteen patients were recruited to ensure adequate statistical power while compensating for possible attrition. To safeguard methodological quality, several measures were implemented. Outcome assessment was examiner-blinded, and all clinical procedures were performed by a single experienced operator who had undergone calibration in intraoral scanning to minimize operator-related variability. Fabrication protocols were standardized, including uniform denture base thickness across workflows. Fit evaluation was conducted using high-resolution industrial scanning, anti-glare surface preparation, and validated surface-matching software with predefined anatomical measurement points. Statistical analyses were performed using established parametric and non-parametric tests, with significance thresholds set at p \< 0.05. Together, these registry procedures and quality factors ensured rigorous data collection, minimized bias, and enhanced the reliability of comparative assessments across conventional and digital denture fabrication workflows

Interventions

OTHERAccuracy of digital workflow

The study tested the fit accuracy of maxillary complete denture bases fabricated through four distinct clinical workflow

Sponsors

Istanbul University
Lead SponsorOTHER
Istanbul University Scientific Research Projects Coordination Unit- Pending
CollaboratorUNKNOWN

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Completely edentulous in the maxillary arch * Age between 18 and 65 years * No systemic disease * No psychiatric disorder * No history of alcohol or drug abuse

Exclusion criteria

* Severe ridge resorption * Extensive maxillary undercuts Dementia * Malignant neoplasms * Dependence on caregivers * Any condition compromising treatment reliability or repeated clinical visits

Design outcomes

Primary

MeasureTime frameDescription
Overall fit accuracy values (mean ± SD, 95% CI) for the study groups6 monthThe study tested the fit accuracy of maxillary complete denture bases fabricated through four distinct clinical workflows-conventional, fully digital, hybrid early, and hybrid late.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORDeger Ongul, Dr.

Istanbul University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026