Artificial Intelligence in Dental Crown DesignNCT07834957
Clinical Evaluation of AI-Driven Designed Single Crowns
A study testing Dental Technician Crown Design and AI-Driven Automated Crown Design in people with Artificial Intelligence in Dental Crown Design and Tooth Crown Restoration, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This clinical study compares tooth-supported single crowns designed by a dental technician and by an artificial intelligence (AI) driven automated design method. The two design methods are qualitatively compared in terms of buccal and lingual/palatal contours, proximal and occlusal contacts, and marginal fit using… Read more about this study
- Who is it for?
- Ages 20 to 39 years
- Conditions the study is for
- Artificial Intelligence in Dental Crown Design, Tooth Crown Restoration, Dental Restorations
- What is being tested?
- Dental Technician Crown Design and AI-Driven Automated Crown Design
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Mar 2026to 23 Jul 2026
- Phase
- Interventional
- 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 20 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Provision of written informed consent to participate in the study
- Adults aged 20-39 years
- Good general and local periodontal health with adequate oral hygiene
- Indication for a single full-coverage crown restoration in the posterior region
- Asymptomatic abutment tooth on clinical examination
- No periradicular radiolucency associated with the abutment tooth on periapical radiographic examination
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- Sufficient remaining tooth structure without the need for a post-and-core restoration, allowing preservation of at least three axial walls after preparation, achievement of a ferrule with at least 1 mm of sound tooth structure coronal to the gingival level, and standardized finish-line preparation
- Presence of intact natural teeth or restorations mesial and distal to the abutment tooth and an opposing tooth or restoration allowing establishment of occlusal contact
- Stable interarch occlusal relationship
- No parafunctional habits
Who cannot join
- Refusal to provide written informed consent
- Serious systemic disease or condition that may contraindicate or interfere with tooth preparation and restorative treatment, including steroid therapy, uncontrolled diabetes mellitus, immunological disorders, pregnancy, or conditions preventing adequate cooperation
- Systemic or local risk factors that may affect the treatment process, including active periodontal disease or inadequate oral hygiene
- History of allergy to local anesthetics containing epinephrine
- Functional or muscular temporomandibular disorders limiting mouth opening
- Parafunctional habits such as bruxism
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Dentistry, Department of Prosthodontics
Ankara, Ankara, 06100
About this study
Official title: Evaluation of Tooth-Supported Single-Crown Restorations Produced With Artificial Intelligence-Driven Design in a Fully Digital Workflow: A Clinical Study
This clinical study compares tooth-supported single crowns designed by a dental technician and by an artificial intelligence (AI) driven automated design method. The two design methods are qualitatively compared in terms of buccal and lingual/palatal contours, proximal and occlusal contacts, and marginal fit using clinical evaluation. The two design methods are quantitatively compared in terms of global, buccal, and lingual/palatal surface deviations using three-dimensional surface deviation analysis.
Read the detailed description
This methodological clinical study evaluates tooth-supported single crowns produced using two different digital design methods within a fully digital workflow. For each participant, two crown restorations are designed for the same prepared posterior tooth: one by an experienced dental technician using conventional computer-aided design (CAD) software and the other using an artificial intelligence (AI)-driven automated design system. Both restorations are produced using the same manufacturing workflow and are clinically evaluated under standardized conditions.
The two restorations are evaluated for buccal and lingual/palatal crown contours, mesial and distal proximal contacts, occlusal contacts, and marginal adaptation using predefined clinical criteria. In addition, three-dimensional (3D) surface deviation analysis is performed to quantitatively compare the two design methods at the global, buccal, and lingual/palatal surface levels.
The study uses a within-participant comparison design, with both design methods evaluated on the same prepared tooth, thereby minimizing variability related to patient- and tooth-specific factors.
- Conditions
- Artificial Intelligence in Dental Crown Design, Tooth Crown Restoration, Dental Restorations
- Being tested
- Dental Technician Crown Design, AI-Driven Automated Crown Design
- Keywords
- Artificial Intelligence, Dental Crown, Computer-Aided Design, Digital Dentistry, Dental Restoration, Clinical Evaluation, Surface Deviation Analysis, Fully Digital Workflow, Single Crown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Technician Crown DesignDevice
Single-crown restorations were designed by an experienced dental technician using 3Shape Dental System based on intraoral scan data. The restorations were designed using predefined contact parameters and a standardized CAD morphology library.
AI-Driven Automated Crown DesignDevice
Single-crown restorations were automatically designed for the same prepared teeth using the AI-driven 3Shape Automate platform based on intraoral scan data. The restorations were designed using contact parameters and a CAD morphology library standardized to those used in the dental technician design method.
| Study group | Role | What they receive |
|---|---|---|
| Within-Participant Comparison of Crown Design Methods | Other | Each participant receives two single-crown restorations fabricated for the same prepared tooth using dental technician design and AI-driven automated design for within-participant comparison. Receives: Device: Dental Technician Crown Design; Device: AI-Driven Automated Crown Design |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Evaluation of Buccal and Lingual/Palatal Crown Contours
Dental technician-designed and AI-driven restorations are clinically evaluated for buccal and lingual/palatal crown contours using modified California Dental Association (CDA) criteria. Buccal and lingual/palatal surfaces are scored separately, and the scoring system distinguishes overcontour from undercontour.
Measured: Day 1
Clinical Evaluation of Proximal Contacts
Dental technician-designed and AI-driven restorations are clinically evaluated for mesial and distal proximal contacts using modified California Dental Association (CDA) criteria. Mesial and distal contacts are scored separately for each restoration.
Measured: Day 1
Clinical Evaluation of Occlusal Contacts
Dental technician-designed and AI-driven restorations are clinically evaluated for occlusal contacts using modified California Dental Association (CDA) criteria. Occlusal contacts are scored for each restoration using the predefined ordinal scoring system.
Measured: Day 1
Clinical Evaluation of Marginal Adaptation
Dental technician-designed and AI-driven restorations are clinically evaluated for marginal adaptation using modified California Dental Association (CDA) criteria. Marginal adaptation is scored for each restoration using the predefined ordinal scoring system.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start9 Mar 2026
- Primary completion27 Apr 2026
- Study completion23 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Artificial Intelligence in Dental Crown DesignStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- For each participant, two single-crown restorations are fabricated for the same prepared tooth: one designed by a dental technician and the other using an AI-driven automated design method. The two restorations are evaluated in a randomized order during the same clinical session and compared qualitatively through clinical assessment and quantitatively using three-dimensional surface deviation analysis.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kıvanç Akça, Hacettepe University
- Investigators
- Kıvanç Akça, DDS, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834957
- Sponsor's protocol ID
- KA-24078
- Other IDs
- E-61749811-000-4330602
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon completion of the study, individual participant data will be securely archived and will not be shared with researchers outside the study team.
Publications
Nagata K, Inoue E, Nakashizu T, Seimiya K, Atsumi M, Kimoto K, Kuroda S, Hoshi N. Verification of the accuracy and design time of crowns designed with artificial intelligence. J Adv Prosthodont. 2025 Feb;17(1):1-10. doi: 10.4047/jap.2025.17.1.1. Epub 2025 Feb 24.
PubMed 40061025Sawangsri K, Bekkali M, Lutz N, Alrashed S, Hsieh YL, Lai YC, Arreaza C, Nassani LM, Hammoudeh HS. Acceptability and deviation of finish line detection and restoration contour design in single-unit crown: Comparative evaluation between 2 AI-based CAD software programs and dental laboratory technicians. J Prosthet Dent. 2025 Aug;134(2):409-417. doi: 10.1016/j.prosdent.2025.03.037. Epub 2025 Apr 14.
PubMed 40234164
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tooth-Supported Single-Crown Restorations Produced With Artificial Intelligence-Driven Design in a Fully Digital Workflow: A Clinical Study
- ClinicalTrials.gov ID
- NCT07834957
- Acronym / sponsor ID
- KA-24078
- Conditions
- Artificial Intelligence in Dental Crown Design, Tooth Crown Restoration, Dental Restorations
- Keywords
- Artificial Intelligence, Dental Crown, Computer-Aided Design, Digital Dentistry, Dental Restoration, Clinical Evaluation, Surface Deviation Analysis, Fully Digital Workflow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 27 Apr 2026 (actual)
- Study completion
- 23 Jul 2026 (actual)
- First posted
- 22 Sep 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.
This clinical study compares tooth-supported single crowns designed by a dental technician and by an artificial intelligence (AI) driven automated design method. The two design methods are qualitatively compared in terms of buccal and lingual/palatal contours, proximal and occlusal contacts, and marginal fit using clinical evaluation. The two design methods are quantitatively compared in terms of global, buccal, and lingual/palatal surface deviations using three-dimensional surface deviation analysis.
Detailed description
This methodological clinical study evaluates tooth-supported single crowns produced using two different digital design methods within a fully digital workflow. For each participant, two crown restorations are designed for the same prepared posterior tooth: one by an experienced dental technician using conventional computer-aided design (CAD) software and the other using an artificial intelligence (AI)-driven automated design system. Both restorations are produced using the same manufacturing workflow and are clinically evaluated under standardized conditions.
The two restorations are evaluated for buccal and lingual/palatal crown contours, mesial and distal proximal contacts, occlusal contacts, and marginal adaptation using predefined clinical criteria. In addition, three-dimensional (3D) surface deviation analysis is performed to quantitatively compare the two design methods at the global, buccal, and lingual/palatal surface levels.
The study uses a within-participant comparison design, with both design methods evaluated on the same prepared tooth, thereby minimizing variability related to patient- and tooth-specific factors.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- For each participant, two single-crown restorations are fabricated for the same prepared tooth: one designed by a dental technician and the other using an AI-driven automated design method. The two restorations are evaluated in a randomized order during the same clinical session and compared qualitatively through clinical assessment and quantitatively using three-dimensional surface deviation analysis.
| Arm | Type | Receives |
|---|---|---|
| Within-Participant Comparison of Crown Design Methods | Other | Device: Dental Technician Crown Design, Device: AI-Driven Automated Crown DesignEach participant receives two single-crown restorations fabricated for the same prepared tooth using dental technician design and AI-driven automated design for within-participant comparison. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Provision of written informed consent to participate in the study
- Adults aged 20-39 years
- Good general and local periodontal health with adequate oral hygiene
- Indication for a single full-coverage crown restoration in the posterior region
- Asymptomatic abutment tooth on clinical examination
Key exclusion criteria (6 listed)
- Refusal to provide written informed consent
- Serious systemic disease or condition that may contraindicate or interfere with tooth preparation and restorative treatment, including steroid therapy, uncontrolled diabetes mellitus, immunological disorders, pregnancy, or conditions preventing adequate cooperation
- Systemic or local risk factors that may affect the treatment process, including active periodontal disease or inadequate oral hygiene
- History of allergy to local anesthetics containing epinephrine
- Functional or muscular temporomandibular disorders limiting mouth opening
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 |
|---|---|---|
| Dental Technician Crown DesignSingle-crown restorations were designed by an experienced dental technician using 3Shape Dental System based on intraoral scan data. The restorations were designed using predefined contact parameters and a standardized CAD morphology library. | Device | Within-Participant Comparison of Crown Design Methods |
| AI-Driven Automated Crown DesignSingle-crown restorations were automatically designed for the same prepared teeth using the AI-driven 3Shape Automate platform based on intraoral scan data. The restorations were designed using contact parameters and a CAD morphology library standardized to those used in the dental technician design method. | Device | Within-Participant Comparison of Crown Design Methods |
Primary outcome
Clinical Evaluation of Buccal and Lingual/Palatal Crown Contours
Time frame: Day 1
Dental technician-designed and AI-driven restorations are clinically evaluated for buccal and lingual/palatal crown contours using modified California Dental Association (CDA) criteria. Buccal and lingual/palatal surfaces are scored separately, and the scoring system distinguishes overcontour from undercontour.
Clinical Evaluation of Proximal Contacts
Time frame: Day 1
Dental technician-designed and AI-driven restorations are clinically evaluated for mesial and distal proximal contacts using modified California Dental Association (CDA) criteria. Mesial and distal contacts are scored separately for each restoration.
Clinical Evaluation of Occlusal Contacts
Time frame: Day 1
Dental technician-designed and AI-driven restorations are clinically evaluated for occlusal contacts using modified California Dental Association (CDA) criteria. Occlusal contacts are scored for each restoration using the predefined ordinal scoring system.
Clinical Evaluation of Marginal Adaptation
Time frame: Day 1
Dental technician-designed and AI-driven restorations are clinically evaluated for marginal adaptation using modified California Dental Association (CDA) criteria. Marginal adaptation is scored for each restoration using the predefined ordinal scoring system.
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 22 Sep 2026.
- Background: PubMed 40061025Nagata K, Inoue E, Nakashizu T, Seimiya K, Atsumi M, Kimoto K, Kuroda S, Hoshi N. Verification of the accuracy and design time of crowns designed with artificial intelligence. J Adv Prosthodont. 2025 Feb;17(1):1-10. doi: 10.4047/jap.2025.17.1.1. Epub 2025 Feb 24.
- Background: PubMed 40234164Sawangsri K, Bekkali M, Lutz N, Alrashed S, Hsieh YL, Lai YC, Arreaza C, Nassani LM, Hammoudeh HS. Acceptability and deviation of finish line detection and restoration contour design in single-unit crown: Comparative evaluation between 2 AI-based CAD software programs and dental laboratory technicians. J Prosthet Dent. 2025 Aug;134(2):409-417. doi: 10.1016/j.prosdent.2025.03.037. Epub 2025 Apr 14.
- Individual participant dataSharing planned: No. Upon completion of the study, individual participant data will be securely archived and will not be shared with researchers outside the study team.
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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.
Kıvanç Akça, DDS, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Technician Crown Design and AI-Driven Automated Crown Design in people with Artificial Intelligence in Dental Crown Design and Tooth Crown Restoration, run by Hacettepe 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 10 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 22 Sep 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?
Clinical Evaluation of Buccal and Lingual/Palatal Crown Contours (time frame: Day 1). The study lists 4 primary outcomes in all. 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 NCT07834957, which also lists 2 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 22 Sep 2026.