Completed

NCT Number: NCT07795983

Influence of Digital Workflows on Maxillary Complete Denture Base Accuracy

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.

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Key information

Conditions

Total Edentulism Denture, Complete Removable Total Denture

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University, Faculty of dentistry

Istanbul, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Accuracy of digital workflow

Other

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

Primary outcomes

Overall fit accuracy values (mean ± SD, 95% CI) for the study groups

Time frame: 6 month

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.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Collaborators

Istanbul University Scientific Research Projects Coordination Unit- Pending

Registry information

Official study title

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

Acronym: DigitalTech

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Aug 31, 2026
Registry last updated: Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed