Influence of Digital Workflows on Maxillary Complete Denture Base Accuracy

NCT07795983 | Completed

• 3 other identifiers: Department of ProshodonticsTDK-2024-2476686Adep-TDK- 2024-40536
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Edentulism; Removable Total Denture; Denture, Complete

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  6 month

Study Arms (1)

Thirteen edentulous patients received four maxillary CDBs each, produced via conventional (C), fully

Thirteen completely edentulous patients in the maxillary arch (mean age 58 ± 3 years; 7 males, 6 females) were recruited from the patient pool at the Department of Prosthodontics, Istanbul University. Inclusion criteria required age between 18-65 years, absence of systemic or psychiatric disease, and no history of alcohol or drug abuse. Patients with severe ridge resorption, extensive undercuts, dementia, malignancy, or caregiver dependence were excluded. Each participant underwent fabrication of four denture bases-Conventional, Fully Digital, Hybrid Early, and Hybrid Late-allowing intra-patient comparison across workflows. Ethical approval was obtained, and written informed consent was secured in accordance with the Declaration of Helsinki.

Other: Accuracy of digital workflow

Interventions

Accuracy of digital workflow OTHER

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

Thirteen edentulous patients received four maxillary CDBs each, produced via conventional (C), fully

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants were randomly selected from the waiting list of patients scheduled for complete denture treatment at the Department of Prosthodontics, Faculty of Dentistry, Istanbul University. All fabrication workflows were performed for each participant; therefore, allocation indicated the fabrication workflow rather than participant assignment to different groups.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul University: lead
• Istanbul University Scientific Research Projects Coordination Unit- Pending: collaborator

Study Sites (1)

Istanbul University, Faculty of dentistry

Istanbul, Turkey (Türkiye)

Location

Related Publications (7)

• Song S, Zhang J, Liu M, Li F, Bai S. Effect of build orientation and layer thickness on manufacturing accuracy, printing time, and material consumption of 3D printed complete denture bases. J Dent. 2023 Mar;130:104435. doi: 10.1016/j.jdent.2023.104435. Epub 2023 Jan 21.

  PMID: 36693587 BACKGROUND

• Avelino MEL, Costa RTF, Vila-Nova TEL, Vasconcelos BCDE, Pellizzer EP, Moraes SLD. Clinical performance and patient-related outcome measures of digitally fabricated complete dentures: A systematic review and meta-analysis. J Prosthet Dent. 2024 Oct;132(4):748.e1-748.e10. doi: 10.1016/j.prosdent.2024.02.003. Epub 2024 Mar 13.

  PMID: 38485595 BACKGROUND

• Park C. A comprehensive narrative review exploring the current landscape of digital complete denture technology and advancements. Heliyon. 2025 Jan 10;11(2):e41870. doi: 10.1016/j.heliyon.2025.e41870. eCollection 2025 Jan 30.

  PMID: 39906853 BACKGROUND

• Casucci A, Verniani G, Bonadeo G, Fadil S, Ferrari M. Analog and digital complete denture bases accuracy and dimensional stability: An in-vitro evaluation at 24 hours and 6 months. J Dent. 2025 Jun;157:105658. doi: 10.1016/j.jdent.2025.105658. Epub 2025 Mar 2.

  PMID: 40037466 BACKGROUND

• Maniewicz S, Imamura Y, El Osta N, Srinivasan M, Muller F, Chebib N. Fit and retention of complete denture bases: Part I - Conventional versus CAD-CAM methods: A clinical controlled crossover study. J Prosthet Dent. 2024 Apr;131(4):611-617. doi: 10.1016/j.prosdent.2022.07.006. Epub 2022 Sep 15.

  PMID: 36116950 BACKGROUND

• Qadir, G.O.; Abdulkareem, J.F. An In Vitro Comparative Study of Maxillary Denture Base Retention Between Con-ven-tional Fabrication and 3D Printed Techniques. Sulaimani Dent. 2023, 10, 45-53. https://doi.org/10.17656/sdj.10173.

  BACKGROUND

• https://doi.org/10.1111/j.1365-2842.2009.02039.x

  BACKGROUND

Study Officials

• Deger Ongul, Dr.

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator Assoc. Prof. Dr.

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 31, 2026
• Study Start: March 12, 2024
• Primary Completion: May 20, 2025
• Study Completion: January 5, 2026
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)