Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT07180732
Status:
COMPLETED
Last Update Posted:
2025-09-18
First Post:
2025-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Accuracy of Injection Moulding Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2025-09-12', 'studyFirstSubmitQcDate': '2025-09-12', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy', 'timeFrame': 'From enrolment to the end of treatment after 4 weeks', 'description': 'The root mean square (RMS) values were obtained through the "3D-compare" method followed by comparison at each surface point between the reference digital design desing and the final outcome using injection moulding'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Injection moulding', 'Veneers', 'Accuracy', 'Geomagic', 'resin composite'], 'conditions': ['Esthetic Restorations']}, 'descriptionModule': {'briefSummary': 'To evaluate the discrepancy between the digital smile design (DSD) and the resulting direct composite veneers via Injection Moulding Technique.', 'detailedDescription': 'This study will be aiming at testing the accuracy of the injection moulding technique compared with the digital smile design, therefore improving the outcome of composite veneers for the patients in order to reach more predictable results. Utilizing a quantitative method to assess accuracy of Injection moulding technique is deficient in literature and using a geometrical subtraction software will be an objective method to compare the difference with the digital smile design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants requiring smile make-over\n* Good oral hygiene\n* Compliance\n\nExclusion Criteria:\n\n* Poor oral hygiene\n* Need for orthodontic treatment\n* Need of full coverage restoration\n* Parafunctional habits\n* Lack of compliance'}, 'identificationModule': {'nctId': 'NCT07180732', 'briefTitle': 'Accuracy of Injection Moulding Technique', 'organization': {'class': 'OTHER', 'fullName': 'NewGiza University'}, 'officialTitle': 'Accuracy of Direct Composite Veneers Using Injection Moulding Technique', 'orgStudyIdInfo': {'id': 'Accuracy of injection mouldong'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Injection moudling technique', 'description': 'A dental procedure where a patient-approved tooth shape, established from a diagnostic wax-up, is replicated using a transparent silicone index', 'interventionNames': ['Procedure: Injection moulding technique']}, {'type': 'OTHER', 'label': 'Digital smile design', 'description': 'Baseline smile design', 'interventionNames': ['Diagnostic Test: Digital smile design']}], 'interventions': [{'name': 'Injection moulding technique', 'type': 'PROCEDURE', 'description': 'A dental technique that uses a transparent silicone index or stent to inject a low-viscosity composite into a pre-planned and approved tooth shape.', 'armGroupLabels': ['Injection moudling technique']}, {'name': 'Digital smile design', 'type': 'DIAGNOSTIC_TEST', 'description': "A modern approach that uses digital imaging, videos, and software to create a customized, virtual 3D model of a patient's ideal smile before any treatment begins", 'armGroupLabels': ['Digital smile design']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12577', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'School of dentistry, Newgiza University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Omar O Shaalan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor, Department of conservative dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared due to concerns regarding participant privacy and the absence of explicit consent for data sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NewGiza University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor of conservative dentistry', 'investigatorFullName': 'Omar Shaalan', 'investigatorAffiliation': 'NewGiza University'}}}}