A Comparative Clinical Study to Evaluate Crowns Designed by Artificial Intelligence Versus Crowns Designed Traditional Design Software

NCT ID: NCT07099261

Last Updated: 2025-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-09-01

Brief Summary

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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

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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 AIÙ€CAD Versus Crowns Designed by Traditional Design Software One Traditional CAD by assessing the following metrics:

1. Marginal fit accuracy
2. Quality of contact points
3. 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

1. 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. Designing : Send the digital model to selected crown design programs (both AI-driven and traditional).
5. Crown Fabrication: After design approval, crowns will be produced from PMMA using a milling unit.
6. 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

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Dental Crown

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

self controlled clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Crowns designed with AI powered dentibird

10 Crowns designed with AI powered dentbird

Group Type EXPERIMENTAL

Crowns

Intervention Type OTHER

1. 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

Crowns designed with AI powered Exocad

10 Crowns designed with AI powered Exocad

Group Type EXPERIMENTAL

Crowns

Intervention Type OTHER

1. 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

Crowns designed with conventional Exocad

10 Crowns designed with conventional Exocad (computer aided experienced)

Group Type SHAM_COMPARATOR

Crowns

Intervention Type OTHER

1. 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

Interventions

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Crowns

1. 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

Intervention Type OTHER

Other Intervention Names

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dental crowns

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Abnormal occlusal habits such as bruxism
* Active periodontal diseases
* Allergy to crown materials (e.g., polymethyl methacrylate, PMMA)
* Poor oral hygiene
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tishreen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zeyad Handhal, master's student

Role: PRINCIPAL_INVESTIGATOR

Tishreen University

Rima Saker, Assistant professor

Role: STUDY_CHAIR

Tishreen University

Central Contacts

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Zeyad Handhal, master's student

Role: CONTACT

00963981898264

Rima Saker, Assistant professor

Role: CONTACT

00963949831419

Related Links

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https://doi.org/10.1016/j.jds.2025.03.016

Evaluation of the accuracy, occlusal contact and clinical applications of zirconia crowns using artificial intelligence design versus human design

https://doi.org/10.1016/j.heliyon.2024.e24205

Impact of different CAD software programs on marginal and internal fit of provisional crowns: An in vitro study

https://doi.org/10.1016/j.jdent.2023.104739

Time efficiency, occlusal morphology, and internal fit of anatomic contour crowns designed by dental software powered by generative adversarial network: A comparative study

https://doi.org/10.4047/jap.2025.17.1.1

Verification of the accuracy and design time of crowns designed with artificial intelligence

Other Identifiers

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Tishreen U Ù€Prosthodontics

Identifier Type: -

Identifier Source: org_study_id

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