Dental CrownAINCT07099261
A Comparative Clinical Study to Evaluate Crowns Designed by Artificial Intelligence Versus Crowns Designed Traditional Design Software
A study testing Crowns in people with Dental Crown, run by Latakia University.
Trial summary
This clinical research aims to Evaluate Crowns Designed by Artificial Intelligence Versus Crowns Designed by Traditional Design Software The research will be conducted on a sample of patients with an indication for crowning of the first lower molar. Ten dental crowns will be prepared. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Crown
- What is being tested?
- Crowns
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 18-60 years requiring a crown for a lower first molar
- Good oral and gingival health
- adjacent teeth in good condition
- Natural opposing teeth
- Willingness to participate and sign informed consent
Who cannot join
- Abnormal occlusal habits such as bruxism
- Active periodontal diseases
- Allergy to crown materials (e.g., polymethyl methacrylate, PMMA)
- Poor oral hygiene
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Comparative Clinical Study to Evaluate Crowns Designed by Artificial Intelligence Versus a Crowns Designed Traditional Design Software
This clinical research aims to Evaluate Crowns Designed by Artificial Intelligence Versus Crowns Designed by Traditional Design Software
The research will be conducted on a sample of patients with an indication for crowning of the first lower molar. Ten dental crowns will be prepared.
Read more
After obtaining written consent from patients who meet the inclusion and exclusion criteria, 10 dental crowns will be prepared. Measurements will be taken using silicone impressions and then converted into digital format.
The digital impression will be sent to the selected dental restoration design software used in the study. The same parameters will be adjusted in all software programs for each crown.
After the design is completed, the designs will be sent to the milling unit. For each case, three crowns will be designed and milled from polymethyl methacrylate (PMMA).
The crown will be clinically examined and evaluated according to specific criteria. Marginal fit, proximal contact quality, and occlusion will be assessed.
The best crown will be milled from zirconia and delivered to the patient.
Read the detailed description
Recent advancements in artificial intelligence (AI) have revolutionized various fields, including dentistry, where AI systems are being promoted to reduce design time for dental restorations. However, it remains unclear whether this increased speed compromises critical factors such as marginal fit accuracy, occlusion, and contact points-elements crucial for the success of dental prosthetics. The existing scientific evidence regarding the efficiency of AI-supported dental design systems is limited. A review of the literature revealed only one clinical study addressing this aspect, highlighting the urgent need for further comparative research.
This clinical research aims to Evaluate Crowns Designed by two Artificial Intelligence computer-aided AIـCAD Versus Crowns Designed by Traditional Design Software One Traditional CAD by assessing the following metrics:
- Marginal fit accuracy
- Quality of contact points
- Occlusion
Importance of the Research
Given the scarcity of studies focusing on AI-based crown design systems clinically, this research will assist dental clinics and laboratories in making informed decisions regarding the adoption of AI technologies versus continuing with traditional methodologies.
Study Design
self controlled clinical trial
Clinical Procedures
- Tooth Preparation: Prepare the teeth to receive a zirconia crown.
- Impression Taking: Obtain impressions using silicone.
- Digital Conversion: Convert impressions into a digital model using a laboratory scanner.
- Designing : Send the digital model to selected crown design programs (both AI-driven and traditional).
- Crown Fabrication: After design approval, crowns will be produced from PMMA using a milling unit.
- Clinical Evaluation: Conduct a clinical assessment of the crowns. Evaluation Metrics
Marginal Fit Accuracy
Measurement clinically using a probe. Comparison with silicone replica technique or Analysis through 3D modeling software (X control GEOM).
Contact Points Quality
Measure the force required to pull a dental floss between teeth.
Occlusion Assessment
Utilize 100-micron and 12-micron articulating paper and Shimstock to evaluate occlusal contact points.
Data will be analyzed using appropriate statistical methods to compare the outcomes between AI-driven designs and traditional methods, ensuring robust conclusions regarding their efficacy.
The results of this study are anticipated to provide valuable insights into the reliability and quality of AI-based crown design systems compared to traditional methods, guiding dental practices in their decision-making processes regarding technology adoption.
This proposal serves as a foundation for conducting a thorough investigation into the effectiveness of AI in dental crown design, addressing a critical gap in current research and practice
- Conditions
- Dental Crown
- Being tested
- Crowns
- Keywords
- Crowns, Crowns Designed by Artificial Intelligence, Artificial intelligence(AI), CAD, CAD\CAM, computer-aided design and computer-aided manufacturing, prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrownsOther
Also called dental crowns
- Tooth Preparation: Prepare the teeth to receive a zirconia crown.
- Impression Taking: Obtain impressions using silicone.
- Digital Conversion: Convert impressions into a digital model using a laboratory scanner.
- Design Submission: Send the digital model to selected crown design program.
- Crown Fabrication: crowns designed will be produced from PMMA using a milling unit.
- Clinical Evaluation: Conduct a clinical assessment of the crowns
- the best crown design will be milled from zirconia and delivered
Evaluation of Crowns designed by following metrics:
- Marginal fit
- proximal contact
- Occlusion
| Study group | Role | What they receive |
|---|---|---|
| Crowns designed with AI powered dentibird | Experimental | 10 Crowns designed with AI powered dentbird Receives: Other: Crowns |
| Crowns designed with AI powered Exocad | Experimental | 10 Crowns designed with AI powered Exocad Receives: Other: Crowns |
| Crowns designed with conventional Exocad | Sham comparator | 10 Crowns designed with conventional Exocad (computer aided experienced) Receives: Other: Crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Fit
Evaluation is conducted by 2 dentists to determine whether the restoration is clinically acceptable or unacceptable using an explorer
or The silicone replica technique (Silicone Replica Technique) is used to evaluate the marginal fit of crowns using silicone material
or Evaluation is conducted using Geomagic X
Measured: immediately after delivering the crown
Clinical evaluation of proximal contact points
To evaluate the interproximal contact points of the crown clinically using waxed dental floss: if the floss passes with slight resistance, the contact points are considered acceptable if the floss passes without resistance, the contact points are considered unacceptable if the floss hard to pass or tearing, the contact points are considered Tight Contact
Measured: immediately after delivering the crown
clinical evaluation of the occlusion
Clinical Evaluation of Occlusion Using Articulating Paper Excellent (both 100- and 12-mm articulating paper imprints exist on the crown and adjacent teeth) nice occlusal contact distribution Good (only 100-mm articulating paper imprints exist on adjacent teeth) Individual occlusal contact points missing or deviated but occlusal contacts on main supporting cusp Satisfactory crown too high, thus supra occlusion No occlusal contacts on supporting cusps but contacts present on other parts of occlusal surface
Unsatisfactory No occlusal contact points on crown(infra occlusion)
Measured: immediately after delivering the crown
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CrownStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- self controlled clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Latakia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeyad Handhal, master's student, Principal investigator, Latakia UniversityRima Saker, Assistant professor, Study chair, Latakia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099261
- Sponsor's protocol ID
- Tishreen U ـProsthodontics
- Acronym
- AI
- Status last verified
- Jul 2025
- First submitted
- 20 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided yet
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Clinical Study to Evaluate Crowns Designed by Artificial Intelligence Versus a Crowns Designed Traditional Design Software
- ClinicalTrials.gov ID
- NCT07099261
- Acronym / sponsor ID
- AI / Tishreen U ـProsthodontics
- Conditions
- Dental Crown
- Keywords
- Crowns, Crowns Designed by Artificial Intelligence, Artificial intelligence(AI), CAD, CAD\CAM, computer-aided design and computer-aided manufacturing, prosthesis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Latakia UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 1 Aug 2025 (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 research aims to Evaluate Crowns Designed by Artificial Intelligence Versus Crowns Designed by Traditional Design Software
The research will be conducted on a sample of patients with an indication for crowning of the first lower molar. Ten dental crowns will be prepared.
After obtaining written consent from patients who meet the inclusion and exclusion criteria, 10 dental crowns will be prepared. Measurements will be taken using silicone impressions and then converted into digital format.
The digital impression will be sent to the selected dental restoration design software used in the study. The same parameters will be adjusted in all software programs for each crown.
After the design is completed, the designs will be sent to the milling unit. For each case, three crowns will be designed and milled from polymethyl methacrylate (PMMA).
The crown will be clinically examined and evaluated according to specific criteria. Marginal fit, proximal contact quality, and occlusion will be assessed.
The best crown will be milled from zirconia and delivered to the patient.
Detailed description
Recent advancements in artificial intelligence (AI) have revolutionized various fields, including dentistry, where AI systems are being promoted to reduce design time for dental restorations. However, it remains unclear whether this increased speed compromises critical factors such as marginal fit accuracy, occlusion, and contact points-elements crucial for the success of dental prosthetics. The existing scientific evidence regarding the efficiency of AI-supported dental design systems is limited. A review of the literature revealed only one clinical study addressing this aspect, highlighting the urgent need for further comparative research.
This clinical research aims to Evaluate Crowns Designed by two Artificial Intelligence computer-aided AIـCAD Versus Crowns Designed by Traditional Design Software One Traditional CAD by assessing the following metrics:
- Marginal fit accuracy
- Quality of contact points
- Occlusion
Importance of the Research
Given the scarcity of studies focusing on AI-based crown design systems clinically, this research will assist dental clinics and laboratories in making informed decisions regarding the adoption of AI technologies versus continuing with traditional methodologies.
Study Design
self controlled clinical trial
Clinical Procedures
- Tooth Preparation: Prepare the teeth to receive a zirconia crown.
- Impression Taking: Obtain impressions using silicone.
- Digital Conversion: Convert impressions into a digital model using a laboratory scanner.
- Designing : Send the digital model to selected crown design programs (both AI-driven and traditional).
- Crown Fabrication: After design approval, crowns will be produced from PMMA using a milling unit.
- Clinical Evaluation: Conduct a clinical assessment of the crowns. Evaluation Metrics
Marginal Fit Accuracy
Measurement clinically using a probe. Comparison with silicone replica technique or Analysis through 3D modeling software (X control GEOM).
Contact Points Quality
Measure the force required to pull a dental floss between teeth.
Occlusion Assessment
Utilize 100-micron and 12-micron articulating paper and Shimstock to evaluate occlusal contact points.
Data will be analyzed using appropriate statistical methods to compare the outcomes between AI-driven designs and traditional methods, ensuring robust conclusions regarding their efficacy.
The results of this study are anticipated to provide valuable insights into the reliability and quality of AI-based crown design systems compared to traditional methods, guiding dental practices in their decision-making processes regarding technology adoption.
This proposal serves as a foundation for conducting a thorough investigation into the effectiveness of AI in dental crown design, addressing a critical gap in current research and practice
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- self controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Crowns designed with AI powered dentibird | Experimental | Other: Crowns10 Crowns designed with AI powered dentbird |
| Crowns designed with AI powered Exocad | Experimental | Other: Crowns10 Crowns designed with AI powered Exocad |
| Crowns designed with conventional Exocad | Sham comparator | Other: Crowns10 Crowns designed with conventional Exocad (computer aided experienced) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients aged 18-60 years requiring a crown for a lower first molar
- Good oral and gingival health
- adjacent teeth in good condition
- Natural opposing teeth
- Willingness to participate and sign informed consent
Key exclusion criteria (4 listed)
- Abnormal occlusal habits such as bruxism
- Active periodontal diseases
- Allergy to crown materials (e.g., polymethyl methacrylate, PMMA)
- Poor oral hygiene
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 |
|---|---|---|
| CrownsAlso: dental crowns1. Tooth Preparation: Prepare the teeth to receive a zirconia crown. 2. Impression Taking: Obtain impressions using silicone. 3. Digital Conversion: Convert impressions into a digital model using a laboratory scanner. 4. Design Submission: Send the digital model to selected crown design program. 5. Crown Fabrication: crowns designed will be produced from PMMA using a milling unit. 6. Clinical Evaluation: Conduct a clinical assessment of the crowns 7. the best crown design will be milled from zirconia and delivered Evaluation of Crowns designed by following metrics: 1. Marginal fit 2. proximal contact 3. Occlusion | Other | Crowns designed with AI powered Exocad, Crowns designed with AI powered dentibird, Crowns designed with conventional Exocad |
Primary outcome
Marginal Fit
Time frame: immediately after delivering the crown
Evaluation is conducted by 2 dentists to determine whether the restoration is clinically acceptable or unacceptable using an explorer or The silicone replica technique (Silicone Replica Technique) is used to evaluate the marginal fit of crowns using silicone material or Evaluation is conducted using Geomagic X
Clinical evaluation of proximal contact points
Time frame: immediately after delivering the crown
To evaluate the interproximal contact points of the crown clinically using waxed dental floss: if the floss passes with slight resistance, the contact points are considered acceptable if the floss passes without resistance, the contact points are considered unacceptable if the floss hard to pass or tearing, the contact points are considered Tight Contact
clinical evaluation of the occlusion
Time frame: immediately after delivering the crown
Clinical Evaluation of Occlusion Using Articulating Paper Excellent (both 100- and 12-mm articulating paper imprints exist on the crown and adjacent teeth) nice occlusal contact distribution Good (only 100-mm articulating paper imprints exist on adjacent teeth) Individual occlusal contact points missing or deviated but occlusal contacts on main supporting cusp Satisfactory crown too high, thus supra occlusion No occlusal contacts on supporting cusps but contacts present on other parts of occlusal surface Unsatisfactory No occlusal contact points on crown(infra occlusion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Evaluation of the accuracy, occlusal contact and clinical applications of zirconia crowns using artificial intelligence design versus human designLink provided by the sponsor.
- Impact of different CAD software programs on marginal and internal fit of provisional crowns: An in vitro studyLink provided by the sponsor.
- Time efficiency, occlusal morphology, and internal fit of anatomic contour crowns designed by dental software powered by generative adversarial network: A comparative studyLink provided by the sponsor.
- Verification of the accuracy and design time of crowns designed with artificial intelligenceLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Undecided yet
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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.
Zeyad Handhal, master's student principal investigator
Latakia University
Rima Saker, Assistant professor study chair
Latakia University
Questions about this trial
What is this clinical trial studying?
A study testing Crowns in people with Dental Crown, run by Latakia University.
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 4 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: opening soon, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeyad Handhal, master's student (00963981898264, zeyad.handhal@tishreen.edu.sy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal Fit (time frame: immediately after delivering the crown). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2025.