Total EdentulismDigitalTechNCT07795983
Influence of Digital Workflows on Maxillary Complete Denture Base Accuracy
An observational study of Total Edentulism and Removable Total Denture, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Edentulism, Removable Total Denture, Denture, Complete
- What is being tested?
- Accuracy of digital workflow
- How many people
- 13 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Mar 2024to 5 Jan 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Severe ridge resorption
- Extensive maxillary undercuts
- Dementia
- Malignant neoplasms
- Dependence on caregivers
- Any condition compromising treatment reliability or repeated clinical visits
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Faculty of dentistry
Istanbul
About this study
Official title: Influence of Digital Workflows on Maxillary Complete Denture Base Accuracy: A Prospective Clinical 3D Evaluation
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.
Read more
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.
Read the 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
- Conditions
- Total Edentulism, Removable Total Denture, Denture, Complete
- Being tested
- Accuracy of digital workflow
- Keywords
- Digital denture, Fit accuracy, 3D printing, Intraoral scanning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accuracy of digital workflowOther
The study tested the fit accuracy of maxillary complete denture bases fabricated through four distinct clinical workflow
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Accuracy of digital workflow |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start12 Mar 2024
- Primary completion20 May 2025
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Total EdentulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University Scientific Research Projects Coordination Unit- Pending
- Responsible party
- Principal investigator, Deger Ongul, Istanbul University
- Investigators
- Deger Ongul, Dr., Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795983
- Sponsor's protocol ID
- Department of Proshodontics
- Other IDs
- TDK-2024-2476686, Adep-TDK- 2024-40536
- Acronym
- DigitalTech
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to patient confidentiality and privacy considerations. Only aggregated study results will be made available through publications or presentations.
Publications
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.
PubMed 36693587Avelino 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.
PubMed 38485595Park 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.
PubMed 39906853Casucci 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.
PubMed 40037466Maniewicz 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.
PubMed 36116950Qadir, 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.
https://doi.org/10.1111/j.1365-2842.2009.02039.x
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Digital Workflows on Maxillary Complete Denture Base Accuracy: A Prospective Clinical 3D Evaluation
- ClinicalTrials.gov ID
- NCT07795983
- Acronym / sponsor ID
- DigitalTech / Department of Proshodontics
- Conditions
- Total Edentulism, Removable Total Denture, Denture, Complete
- Keywords
- Digital denture, Fit accuracy, 3D printing, Intraoral scanning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Istanbul University Scientific Research Projects Coordination Unit- Pending
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thirteen edentulous patients received four maxillary CDBs each, produced via conventional (C), fully | – | Other: Accuracy of digital workflowThirteen 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Severe ridge resorption
- Extensive maxillary undercuts
- Dementia
- Malignant neoplasms
- Dependence on caregivers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accuracy of digital workflowThe study tested the fit accuracy of maxillary complete denture bases fabricated through four distinct clinical workflow | Other | Thirteen edentulous patients received four maxillary CDBs each, produced via conventional (C), fully |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Background: PubMed 36693587Song 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.
- Background: PubMed 38485595Avelino 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.
- Background: PubMed 39906853Park 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.
- Background: PubMed 40037466Casucci 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.
- Background: PubMed 36116950Maniewicz 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.
- BackgroundQadir, 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.
- Backgroundhttps://doi.org/10.1111/j.1365-2842.2009.02039.x
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to patient confidentiality and privacy considerations. Only aggregated study results will be made available through publications or presentations.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deger Ongul, Dr. principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Edentulism and Removable Total Denture, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall fit accuracy values (mean ± SD, 95% CI) for the study groups (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07795983, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.