Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-29 @ 9:42 AM
Study NCT ID:
NCT07099261
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-01
First Post:
2025-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Clinical Study to Evaluate Crowns Designed by Artificial Intelligence Versus Crowns Designed Traditional Design Software
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003442', 'term': 'Crowns'}], 'ancestors': [{'id': 'D017266', 'term': 'Dental Prosthesis'}, {'id': 'D011476', 'term': 'Prosthodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'self controlled clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2025-07-20', 'studyFirstSubmitQcDate': '2025-07-25', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Marginal Fit', 'timeFrame': 'immediately after delivering the crown', 'description': 'Evaluation is conducted by 2 dentists to determine whether the restoration is clinically acceptable or unacceptable using an explorer\n\nor The silicone replica technique (Silicone Replica Technique) is used to evaluate the marginal fit of crowns using silicone material\n\nor Evaluation is conducted using Geomagic X'}, {'measure': 'Clinical evaluation of proximal contact points', 'timeFrame': 'immediately after delivering the crown', 'description': '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'}, {'measure': 'clinical evaluation of the occlusion', 'timeFrame': 'immediately after delivering the crown', 'description': '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\n\nUnsatisfactory No occlusal contact points on crown(infra occlusion)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Crowns', 'Crowns Designed by Artificial Intelligence', 'Artificial intelligence(AI)', 'CAD', 'CAD\\CAM', 'computer-aided design and computer-aided manufacturing', 'prosthesis'], 'conditions': ['Dental Crown']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://doi.org/10.1016/j.jds.2025.03.016', 'label': 'Evaluation of the accuracy, occlusal contact and clinical applications of zirconia crowns using artificial intelligence design versus human design'}, {'url': 'https://doi.org/10.1016/j.heliyon.2024.e24205', 'label': 'Impact of different CAD software programs on marginal and internal fit of provisional crowns: An in vitro study'}, {'url': 'https://doi.org/10.1016/j.jdent.2023.104739', 'label': 'Time efficiency, occlusal morphology, and internal fit of anatomic contour crowns designed by dental software powered by generative adversarial network: A comparative study'}, {'url': 'https://doi.org/10.4047/jap.2025.17.1.1', 'label': 'Verification of the accuracy and design time of crowns designed with artificial intelligence'}]}, 'descriptionModule': {'briefSummary': 'This clinical research aims to Evaluate Crowns Designed by Artificial Intelligence Versus Crowns Designed by Traditional Design Software\n\nThe 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.\n\nAfter 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.\n\nThe 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.\n\nAfter 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).\n\nThe crown will be clinically examined and evaluated according to specific criteria. Marginal fit, proximal contact quality, and occlusion will be assessed.\n\nThe best crown will be milled from zirconia and delivered to the patient.', 'detailedDescription': '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.\n\nThis 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:\n\n1. Marginal fit accuracy\n2. Quality of contact points\n3. Occlusion\n\nImportance of the Research\n\nGiven 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.\n\nStudy Design\n\nself controlled clinical trial\n\nClinical Procedures\n\n1. Tooth Preparation: Prepare the teeth to receive a zirconia crown.\n2. Impression Taking: Obtain impressions using silicone.\n3. Digital Conversion: Convert impressions into a digital model using a laboratory scanner.\n4. Designing : Send the digital model to selected crown design programs (both AI-driven and traditional).\n5. Crown Fabrication: After design approval, crowns will be produced from PMMA using a milling unit.\n6. Clinical Evaluation: Conduct a clinical assessment of the crowns. Evaluation Metrics\n\nMarginal Fit Accuracy\n\nMeasurement clinically using a probe. Comparison with silicone replica technique or Analysis through 3D modeling software (X control GEOM).\n\nContact Points Quality\n\nMeasure the force required to pull a dental floss between teeth.\n\nOcclusion Assessment\n\nUtilize 100-micron and 12-micron articulating paper and Shimstock to evaluate occlusal contact points.\n\nData will be analyzed using appropriate statistical methods to compare the outcomes between AI-driven designs and traditional methods, ensuring robust conclusions regarding their efficacy.\n\nThe 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.\n\nThis 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18-60 years requiring a crown for a lower first molar\n* Good oral and gingival health\n* adjacent teeth in good condition\n* Natural opposing teeth\n* Willingness to participate and sign informed consent\n\nExclusion Criteria:\n\n* Abnormal occlusal habits such as bruxism\n* Active periodontal diseases\n* Allergy to crown materials (e.g., polymethyl methacrylate, PMMA)\n* Poor oral hygiene'}, 'identificationModule': {'nctId': 'NCT07099261', 'acronym': 'AI', 'briefTitle': 'A Comparative Clinical Study to Evaluate Crowns Designed by Artificial Intelligence Versus Crowns Designed Traditional Design Software', 'organization': {'class': 'OTHER', 'fullName': 'Tishreen University'}, 'officialTitle': 'A Comparative Clinical Study to Evaluate Crowns Designed by Artificial Intelligence Versus a Crowns Designed Traditional Design Software', 'orgStudyIdInfo': {'id': 'Tishreen U Ù€Prosthodontics'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Crowns designed with AI powered dentibird', 'description': '10 Crowns designed with AI powered dentbird', 'interventionNames': ['Other: Crowns']}, {'type': 'EXPERIMENTAL', 'label': 'Crowns designed with AI powered Exocad', 'description': '10 Crowns designed with AI powered Exocad', 'interventionNames': ['Other: Crowns']}, {'type': 'SHAM_COMPARATOR', 'label': 'Crowns designed with conventional Exocad', 'description': '10 Crowns designed with conventional Exocad (computer aided experienced)', 'interventionNames': ['Other: Crowns']}], 'interventions': [{'name': 'Crowns', 'type': 'OTHER', 'otherNames': ['dental crowns'], 'description': '1. Tooth Preparation: Prepare the teeth to receive a zirconia crown.\n2. Impression Taking: Obtain impressions using silicone.\n3. Digital Conversion: Convert impressions into a digital model using a laboratory scanner.\n4. Design Submission: Send the digital model to selected crown design program.\n5. Crown Fabrication: crowns designed will be produced from PMMA using a milling unit.\n6. Clinical Evaluation: Conduct a clinical assessment of the crowns\n7. the best crown design will be milled from zirconia and delivered\n\nEvaluation of Crowns designed by following metrics:\n\n1. Marginal fit\n2. proximal contact\n3. Occlusion', 'armGroupLabels': ['Crowns designed with AI powered Exocad', 'Crowns designed with AI powered dentibird', 'Crowns designed with conventional Exocad']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': "Zeyad Handhal, master's student", 'role': 'CONTACT', 'email': 'zeyad.handhal@tishreen.edu.sy', 'phone': '00963981898264'}, {'name': 'Rima Saker, Assistant professor', 'role': 'CONTACT', 'email': 'rima.saker@tishreen.edu.sy', 'phone': '00963949831419'}], 'overallOfficials': [{'name': "Zeyad Handhal, master's student", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tishreen University'}, {'name': 'Rima Saker, Assistant professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Tishreen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Undecided yet'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tishreen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}