Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-02 @ 11:32 AM
Study NCT ID:
NCT06693635
Status:
COMPLETED
Last Update Posted:
2025-01-01
First Post:
2024-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Evaluation of Implant Planning Software
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007575', 'term': 'Jaw, Edentulous'}, {'id': 'D009066', 'term': 'Mouth, Edentulous'}], 'ancestors': [{'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-30', 'studyFirstSubmitDate': '2024-11-14', 'studyFirstSubmitQcDate': '2024-11-14', 'lastUpdatePostDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Segmentation of Bones', 'timeFrame': '1 day', 'description': 'The segmentation of bone structures and anatomical boundaries performed by the software will be evaluated.'}, {'measure': 'Recognition of Neural structure', 'timeFrame': '1 day', 'description': 'The segmentation and recognition of nerve structures performed by the software will be evaluated.'}, {'measure': 'Segmentation of teeth', 'timeFrame': '1 day', 'description': 'The segmentation of teeth performed by the software will be evaluated.'}, {'measure': 'Bone density', 'timeFrame': '1 day', 'description': 'The bone hardness and density data will be evaluated at three different points. The value will be given on the Hounsfield Scale.'}, {'measure': 'Time Workflow', 'timeFrame': '1 day', 'description': 'The execution time of each planning will be evaluated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Artificial Intelligence in Implantology', 'AI', 'Implant planning', 'AI software'], 'conditions': ['Edentulous Jaw', 'Edentulous Alveolar Ridge', 'Edentulous Mouth', 'Partial-edentulism']}, 'descriptionModule': {'briefSummary': 'Artificial intelligence (AI) is increasingly being integrated into dental implant planning, revolutionizing the way clinicians approach treatment. AI-driven software can enhance the accuracy of implant placement by analyzing complex data sets, including bone density, anatomical structures, and patient-specific factors. This technology enables the creation of precise 3D models and surgical guides, facilitating more predictable and personalized treatment outcomes. Additionally, AI algorithms can automate tasks such as segmentation, matching digital impressions with CBCT scans, and even suggesting optimal implant positions. The integration of AI in implant planning not only improves clinical efficiency but also contributes to better patient outcomes by reducing surgical risks and enhancing the overall success of implant procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients requiring implant rehabilitation with digital planning', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CBCT of Patient who needs Implant rehabilitations\n\nExclusion Criteria:\n\n* Patient not suitable for implant rehabilitation'}, 'identificationModule': {'nctId': 'NCT06693635', 'briefTitle': 'Comparative Evaluation of Implant Planning Software', 'organization': {'class': 'OTHER', 'fullName': 'University of Bari Aldo Moro'}, 'officialTitle': 'Evaluating the Impact of Artificial Intelligence in Implant Planning Software: A Case Study Approach', 'orgStudyIdInfo': {'id': 'AISoftware'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Implant planning', 'type': 'DIAGNOSTIC_TEST', 'description': 'The implant planning will be carried out using various software programs. The AI assistance provided by each software will be evaluated.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70124', 'city': 'Bari', 'country': 'Italy', 'facility': 'University of Bari Aldo Moro', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}], 'overallOfficials': [{'name': "Giuseppe D'Albis, Dr", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bari Aldo Moro'}, {'name': 'Massimo Corsalini, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Bari Aldo Moro'}, {'name': 'Saverio Capodiferro, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Bari Aldo Moro'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bari Aldo Moro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS, MSc', 'investigatorFullName': "Giuseppe D'Albis", 'investigatorAffiliation': 'University of Bari Aldo Moro'}}}}