Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 5:26 AM
Study NCT ID:
NCT07061860
Status:
COMPLETED
Last Update Posted:
2025-07-18
First Post:
2025-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Complete Mandibular Dentures Produced Via 3D Printing in Comparison to Those Constructed From Metal-reinforced Acrylic Resin Regarding Their Retention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-21', 'size': 857174, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-13T05:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'blinding to patient and operator in intervention from begining'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomozied controlled parallel double blinding study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2025-07-01', 'studyFirstSubmitQcDate': '2025-07-10', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'retention measurement', 'timeFrame': 'immediatlly after denture construction', 'description': "To assess retention, a digital force gauge (Digital Force Gauge EXTECH 475044) was employed. All of the mandibular dentures were modified to receive a custom-made metal framework consisting of three tubes connected by a hook at the determining geometric center of the denture, two tubes extend 2 cm above the occlusal plane from the retromolar pad region, and one was made at the midline region lingual and below the central incisors. The mandibular denture's polished surface was then joined to the specially constructed custom-made metal framework using self-curing acrylic resin"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['digital denture', 'retention', 'metal reinforced denture'], 'conditions': ['Edentulous Alveolar Ridge']}, 'descriptionModule': {'briefSummary': 'in this study we will construct denture for patient by different way and material one of this denture constructed digitally and the other one constructed in conventional way with metal reinforced. then we will measure the retention of the dentures', 'detailedDescription': 'the complete denture is constructed for completely edentulous patient. the different technique of construction aim to increase retention of denture to prevent dislodgment during mastication'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Class I maxillary-mandibular relationship\n* well-maintained oral mucosa\n* normal salivary flow\n\nExclusion Criteria:\n\n* smokers patient\n* patient had any abnormalities in hard or soft tissues\n* severe ridge undercut\n* patient received radiation therapy to the head and neck region'}, 'identificationModule': {'nctId': 'NCT07061860', 'acronym': 'retention', 'briefTitle': 'To Evaluate the Complete Mandibular Dentures Produced Via 3D Printing in Comparison to Those Constructed From Metal-reinforced Acrylic Resin Regarding Their Retention', 'organization': {'class': 'OTHER', 'fullName': 'National Research Centre, Egypt'}, 'officialTitle': 'Comparative Study of Retention of Mandibular Denture Bases Three-dimensional (3D) Printing Technique and Metal-reinforced Acrylic Resin', 'orgStudyIdInfo': {'id': '8887082022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'complete edentulous patient receive 3D printed denture', 'description': 'group 1: 10 patients: Complete dentures constructed from poly-methyl methacrylate resin were used to create the mandibular and maxillary 3D-printed dentures', 'interventionNames': ['Device: digital complete denture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'complete edentulous patient receive metal reinforced denture', 'description': 'group 2: 10 patients: complete denture constructed from metal reinforced acrylic denture', 'interventionNames': ['Device: metal reinforced complete denture']}], 'interventions': [{'name': 'digital complete denture', 'type': 'DEVICE', 'description': 'different method of denture construction', 'armGroupLabels': ['complete edentulous patient receive 3D printed denture']}, {'name': 'metal reinforced complete denture', 'type': 'DEVICE', 'description': 'different method of denture construction', 'armGroupLabels': ['complete edentulous patient receive metal reinforced denture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11553', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'National Resaerch Center', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ayman F Elawady, Ass prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National research center, cairo, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no plan to share'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Research Centre, Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor in Prosthodontics Department, Oral and Dental Research Institution, National Research Centre, Cairo, Egypt.', 'investigatorFullName': 'Ayman Fathy Farouk El-Awadi', 'investigatorAffiliation': 'National Research Centre, Egypt'}}}}