Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-28 @ 7:07 AM
Study NCT ID:
NCT06362057
Status:
RECRUITING
Last Update Posted:
2025-03-27
First Post:
2024-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomechanical Effects of Digitally Constructed Subperiosteal Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 9}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-07-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2024-04-08', 'studyFirstSubmitQcDate': '2024-04-08', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bone loss under the implants', 'timeFrame': '10-15 years', 'description': 'amount of bone loss which appears on a modeling process, The modeling process will be completed using a three-dimensional modeling software. A three-dimensional mesh consisting of 556,365 nodes and 2972,897 elements with VRMesh Studio (VirtualGrid Inc, Bellevue City, WA, USA) will used in the program.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polyetherketoneketone', 'Titanium', 'Polyethereetherketone'], 'conditions': ['Bone Loss']}, 'referencesModule': {'references': [{'pmid': '40640731', 'type': 'DERIVED', 'citation': 'El-Sawy MA, El-Khatib B, Borg HS, Khater MT. Biomechanical effects of digitally constructed titanium, modified polyetheretherketone, and polyetherketoneketone subperiosteal implants on atrophied maxilla: a finite element analysis. BMC Oral Health. 2025 Jul 10;25(1):1142. doi: 10.1186/s12903-025-06426-z.'}]}, 'descriptionModule': {'briefSummary': 'Subperiosteal implants were first introduced in 1940 and then used worldwide for the treatment of edentulous maxilla or mandible with advanced bone atrophy.', 'detailedDescription': 'With the advancement of digital technology for the fabrication of materials and the emerging of new materials, subperiosteal implants can be fabricated from a wide variety of materials, and there is a lack of evidence regarding which material could be suitable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a three dimentional finite element analysis', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A 3D image of an edentulous maxilla bone derived from a computed tomography scan of an adult patient.\n* Maxilla with Cawood and Howell class 4 or 5 classification\n\nExclusion Criteria:\n\n* A 2D image of an edentulous maxilla bone\n* A non atrophied maxilla'}, 'identificationModule': {'nctId': 'NCT06362057', 'briefTitle': 'Biomechanical Effects of Digitally Constructed Subperiosteal Implants', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'Biomechanical Effects of Digitally Constructed Subperiosteal Implants From Different Materials With Different Prosthetic Superstructures on Atrophied Maxilla: A Finite Element Analysis', 'orgStudyIdInfo': {'id': '001-130125-017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Titanium framework group', 'description': 'Virtual design for Titanium subperiosteal framework group on atrophied maxilla.', 'interventionNames': ['Other: Subperiosteal implant framework']}, {'label': 'PEEK framework group', 'description': 'Virtual design for PEEK subperiosteal framework group on atrophied maxilla.', 'interventionNames': ['Other: Subperiosteal implant framework']}, {'label': 'PEKK framework group', 'description': 'Virtual design for PEKK subperiosteal framework group on atrophied maxilla.', 'interventionNames': ['Other: Subperiosteal implant framework']}], 'interventions': [{'name': 'Subperiosteal implant framework', 'type': 'OTHER', 'description': 'A 3D image of an edentulous maxilla bone will be derived from a computed tomography scan of an adult patient and saved as "stl" data. The solid geometry of the maxilla, including the cortical and spongious bone, was rebuilt from the "stl" data into the Digital Imaging and Communications in Medicine (DICOM) format with 3D-Doctor (Able Software Corp., MA, USA).\n\nWith the Boolean method, force loading will be achieved between prosthetic parts, subperiosteal implant screws and bone tissues', 'armGroupLabels': ['PEEK framework group', 'PEKK framework group', 'Titanium framework group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12345', 'city': 'Al Mansurah', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohammed A. El-Sawy, PhD', 'role': 'CONTACT', 'email': 'Dr_sawy@windowslive.com', 'phone': '161314522'}, {'name': 'PhD', 'role': 'CONTACT'}], 'facility': 'Mohammed A. El-Sawy', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Mohammed A. El-Sawy, PhD', 'role': 'CONTACT', 'email': 'Dr_sawy@windowslive.com', 'phone': '161314522'}], 'overallOfficials': [{'name': 'Mohammed A. El-Sawy, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Menoufia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The IPD is upon request from the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menoufia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer, Department of Prosthetic dental science, principle investigator', 'investigatorFullName': 'Mohammed El-Sawy', 'investigatorAffiliation': 'Menoufia University'}}}}