Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-09 @ 6:16 AM
Study NCT ID:
NCT07238335
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Digital And Direct Pickup Of Attachments With Digitally Constructed 2-Implant Overdenture Bases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-15', 'studyFirstSubmitDate': '2025-09-23', 'studyFirstSubmitQcDate': '2025-11-15', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Peri-implant marginal alveolar bone height using digital periapical radiograph at baseline (definite insertion), 6 months, ,and 12 months after insertion', 'timeFrame': 'at baseline (definite insertion), at 6 months, and after 12 months after insertion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Estimation of Bone Height Changes']}, 'descriptionModule': {'briefSummary': 'Comparing digital attachment pickup prior to jaw relation registration with intraoral pickup using digitally constructed mandibular overdenture bases is the aim of this study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Upper and lower ridges covered with healthy mucosa\n* Sufficient quality and quantity of alveolar bone\n* Sufficient inter arch space\n* Angle class one relation\n\nExclusion Criteria:\n\n* Active cancer\n* Immune disease\n* Uncontrolled diabetes'}, 'identificationModule': {'nctId': 'NCT07238335', 'briefTitle': 'Comparison Between Digital And Direct Pickup Of Attachments With Digitally Constructed 2-Implant Overdenture Bases', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Comparative Study Between Digital Pick-up of Attachments Before Registration of Jaws Relations and Intraoral Pick-up With Digitally Constructed 2-Implant Mandibular Overdenture Bases : Peri-Implant Alveolar Bone Height Changes', 'orgStudyIdInfo': {'id': 'A05010023RP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'digital pickup before jaw relation', 'interventionNames': ['Device: digital pickup of attachment before jaw relation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'intraoral pickup during insertion', 'interventionNames': ['Device: intraoral pickup of attachment during insertion']}], 'interventions': [{'name': 'digital pickup of attachment before jaw relation', 'type': 'DEVICE', 'description': 'Arm 1 - Digital Pick-up Before Jaw Relation\n\nIntervention Type: Device Description (short): Extraoral digital pick-up of ball attachments on master cast, CAD/CAM denture base fabrication, jaw relation registration, and denture insertion.', 'armGroupLabels': ['digital pickup before jaw relation']}, {'name': 'intraoral pickup of attachment during insertion', 'type': 'DEVICE', 'description': 'Arm 2 - Intraoral Pick-up During Insertion\n\nIntervention Type: Device Description (short): Intraoral direct pick-up of ball attachments during denture insertion after CAD/CAM denture base fabrication and jaw relation registration.', 'armGroupLabels': ['intraoral pickup during insertion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Faculty of Dentistry Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'mohamed m foaud, phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of dentistry Mansoura university removable Prosthodontics department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'master degree', 'investigatorFullName': 'Nesma mousa', 'investigatorAffiliation': 'Mansoura University'}}}}