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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07099261
Acronym
AI
Enrollment
10
Registered
2025-08-01
Start date
2025-10-01
Completion date
2026-09-01
Last updated
2025-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Crown

Keywords

Crowns, Crowns Designed by Artificial Intelligence, Artificial intelligence(AI), CAD, CAD\CAM, computer-aided design and computer-aided manufacturing, prosthesis

Brief 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. 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: 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

Interventions

OTHERCrowns

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

Sponsors

Tishreen University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

self controlled clinical trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Marginal Fitimmediately after delivering the crownEvaluation 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 pointsimmediately after delivering the crownTo 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 occlusionimmediately after delivering the crownClinical 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)

Contacts

Primary ContactZeyad Handhal, master's student
zeyad.handhal@tishreen.edu.sy00963981898264
Backup ContactRima Saker, Assistant professor
rima.saker@tishreen.edu.sy00963949831419

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026