Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-02-25 @ 5:39 PM
Study NCT ID:
NCT06774560
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-14
First Post:
2024-12-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of 3D Printed Versus CAD/CAM Milled Onlays
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-12', 'studyFirstSubmitDate': '2024-12-28', 'studyFirstSubmitQcDate': '2025-01-12', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fracture', 'timeFrame': 'One Year', 'description': 'This outcome will be measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable, Charlie is not accepted'}], 'secondaryOutcomes': [{'measure': 'Retention', 'timeFrame': 'One Year', 'description': 'This outcome will be measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable, Charlie is not accepted'}, {'measure': 'Marginal adaptation', 'timeFrame': 'One Year', 'description': 'This outcome will be measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable, Charlie is not accepted'}, {'measure': 'Marginal discoloration', 'timeFrame': 'One Year', 'description': 'This outcome will be measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable, Charlie is not accepted'}, {'measure': 'Secondary caries', 'timeFrame': 'One Year', 'description': 'This outcome will be measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable, Charlie is not accepted'}, {'measure': 'Post-operative hypersensitivity', 'timeFrame': 'One Year', 'description': 'This outcome will be measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable, Charlie is not accepted'}, {'measure': 'Surface texture', 'timeFrame': 'One Year', 'description': 'This outcome will be measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable, Charlie is not accepted'}, {'measure': 'Anatomic form', 'timeFrame': 'One Year', 'description': 'This outcome will be measured using modified USPH criteria for clinical evaluation of restoration failure where they are given scores Alpha is excellent , Bravo is acceptable, Charlie is not accepted'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Badly Decayed Molars']}, 'descriptionModule': {'briefSummary': 'The digital workflow in dentistry has proven in the past decades to be a time-efficient, multifunctional, effortless, and accessible approach. The inherited shortages milling machines represented by the incapability to produce accurate complex hollow structures may give preference to modern 3D ceramic printing.\n\nComputer-aided-design/computer-aided-manufacturing (CAD/CAM) in dentistry is a digital subtractive approach for manufacturing indirect restorations. Nevertheless, waste materials and milling burs wearing are considered as key disadvantages of CAD/CAM technology, and are the main drive to improve 3D printing technology (additive manufacturing) as the latter has shown considerable efficiency in minimising wasted materials.\n\nAlthough additive manufacturing has been known since the 1980s, its application in dentistry is relatively new and not fully studied with limited research and in vivo studies on their clinical performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge: 25-45 years.\n\n* Males or females.\n* Participants with carious vital ower molars indicated for onlay (one or two missing cusps)\n* Patients with at least 20 teeth under occlusion.\n* Good oral hygiene.\n* Co-operative patients approving to participate in the trial.\n* Have sufficient cognitive ability to understand consent procedures.\n\nExclusion Criteria:\n\n* Participants with parafunctional habits or bruxism.\n* Participants with systemic diseases or disabilities that may affect participation.\n* Heavy smoking.\n* Pregnancy.\n* Lack of compliance.\n* Severe or active periodontal disease.\n* Cognitive impairment.'}, 'identificationModule': {'nctId': 'NCT06774560', 'briefTitle': 'Clinical Evaluation of 3D Printed Versus CAD/CAM Milled Onlays', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical Evaluation of 3D Printed Versus CAD/CAM Milled Onlays Over a Period of One Year: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '3DP_CAD/CAMM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CAD/CAM milled onlays', 'description': 'CAD/CAM has had a lasting impact on the dental market for decades. Its clinical reliability compared to any other dental material has been well documented. Several clinical studies proved its high clinical performance and survival rate. As CAD/CAM systems have become established in producing indirect restorations, it is considered the gold standard of digital manufacturing technology in dentistry.', 'interventionNames': ['Other: CAD/Cam milled onlays']}, {'type': 'EXPERIMENTAL', 'label': '3D printed onlays', 'description': '3D-printed restorations have shown several advantages. Some studies have shown that the edge and internal gap values of 3D printing restorations are significantly lower than those of milling restorations.', 'interventionNames': ['Other: 3D printed onlays']}], 'interventions': [{'name': 'CAD/Cam milled onlays', 'type': 'OTHER', 'description': 'The digital workflow in dentistry has proven in the past decades to be a time-efficient, multifunctional, effortless, and accessible approach. The inherited shortages milling machines represented by the incapability to produce accurate complex hollow structures may give preference to modern 3D ceramic printing.\n\nComputer-aided-design/computer-aided-manufacturing (CAD/CAM) in dentistry is a digital subtractive approach for manufacturing indirect restorations. Nevertheless, waste materials and milling burs wearing are considered as key disadvantages of CAD/CAM technology, and are the main drive to improve 3D printing technology (additive manufacturing) as the latter has shown considerable efficiency in minimising wasted materials.', 'armGroupLabels': ['CAD/CAM milled onlays']}, {'name': '3D printed onlays', 'type': 'OTHER', 'description': '3D printing technologies are developing more intensively in dentistry as this technology has the capacity to produce shapes or models with high accuracy and in a short time. This method of fabrication takes less time and money and saves on materials compared to CAD/CAM.\n\nAlthough it seems that digital manufacturing technology has made great changes in the restorative dentistry field, this technology is still not fully in use. This is possibly because of the lack of studies and research on this technology, particularly in terms of clinical performance and patient-centred outcomes. 3D printing technologies are novel technologies with a lack of research; therefore, the processing of 3D printing materials is still controversial.', 'armGroupLabels': ['3D printed onlays']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nada Sameh assistant lecturer', 'role': 'CONTACT', 'email': 'nada.farouk@dentistry.cu.edu.eg', 'phone': '00201065228277'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Nada Sameh Ahmed Farouk', 'investigatorAffiliation': 'Cairo University'}}}}