Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT07014527
Status:
COMPLETED
Last Update Posted:
2025-06-11
First Post:
2025-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of the Accuracy of Full Digital Workflow in Patient Specific Submerged Subperiosteal Implants: A Case Series Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-07', 'studyFirstSubmitDate': '2025-05-25', 'studyFirstSubmitQcDate': '2025-06-07', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy', 'timeFrame': 'immediately postoperative', 'description': 'accuracy of the position of patient specific subperiosteal implants by superimposition of immediately postoperative CT over the preoperative plan and taking linear measurements (in millimeters)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Edentulous Alveolar Ridge Atrophy', 'ATROPHYC EDENTULOUS JAW', 'Edentulous Maxilla', 'Edentulous Alveolar Ridge In Mandible']}, 'descriptionModule': {'briefSummary': "custom made subperiosteal implants will be designed using the patients' CT data and will be inserted with the help of a surgical guide and loaded by a screw retained full arch prosthesis. accuracy will be assessed"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults patients with severely atrophic alveolar ridges in both maxilla and mandible.\n\nExclusion Criteria:\n\n* Alveolar bone dimensions that can allow for root form implant placement'}, 'identificationModule': {'nctId': 'NCT07014527', 'briefTitle': 'Assessment of the Accuracy of Full Digital Workflow in Patient Specific Submerged Subperiosteal Implants: A Case Series Study', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Assessment of the Accuracy of Full Digital Workflow in Patient Specific Submerged Subperiosteal Implants: A Case Series Study', 'orgStudyIdInfo': {'id': 'OMFS 2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Computer guided custom made subperiosteal implant treatment', 'description': 'Patients will receive a patient specific custom made subperiosteal implant and the accuracy will be assessed', 'interventionNames': ['Procedure: Patient specific subperiosteal implants']}], 'interventions': [{'name': 'Patient specific subperiosteal implants', 'type': 'PROCEDURE', 'description': 'Patient specific subperiosteal implants', 'armGroupLabels': ['Computer guided custom made subperiosteal implant treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of dentistry, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Data will be available upon reasonable request from the authors'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Mohamed Shawky', 'investigatorAffiliation': 'Cairo University'}}}}