Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 12:05 PM
Study NCT ID:
NCT07405918
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-12
First Post:
2026-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
3D Printed Customized Bone Graft for Alveolar Regeneration: Longitudinal Cohort Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D016301', 'term': 'Alveolar Bone Loss'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D001862', 'term': 'Bone Resorption'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '6 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-08', 'studyFirstSubmitDate': '2026-01-21', 'studyFirstSubmitQcDate': '2026-02-08', 'lastUpdatePostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Periodontal Clinical Parameter of the implants Placed in the Grafted area', 'timeFrame': '5 years', 'description': 'Marginal Bone Loss \\< 2mm'}], 'secondaryOutcomes': [{'measure': 'Bone Graft Volume Alteration', 'timeFrame': '6 years', 'description': 'Tomographic Volumetric Measurement (mm3) of the 3D printed graft after a period ranged between 1 to 6 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Personalized bone graft', '3D printed customized bone block', 'Guided Bone Regeneration', 'Personalized Medicine'], 'conditions': ['Periodontal Diseases', 'Periodontal Bone Loss']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the behavior of the implant-supported restorations (prosthesis) placed into the areas grafted with the 3D printed customized bone (personalized graft produced to fit a specific bone defect), as well as the volume contraction of the printed bone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This prospective cohort study will evaluate the peri-implant conditions of patients who received regenerative procedures using 3D-printed blocks at the UnG Clinic. To this end, participants will be selected from the UnG graduate clinic who received the regenerative treatment using 3D-printed blocks between 2019 and 2025. Participants selected for the study must sign the Informed Consent Form (ICF) after a verbal and written explanation of the project. Subjects will receive oral hygiene instruction and professional prophylaxis prior to clinical examinations.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systemically healthy individuals\n* over 18 years of age\n* Subjects that received regenerative surgical treatment by customized 3D printed blocks.\n* Subjects must agree to participate in the study and agree to sign the Informed Consent.\n\nExclusion Criteria:\n\n* Subjects with ilness that avoid their presence to the clinical evaluation\n* ISubjects who have lost the customized blocks\n* Subjects who do not agree to participate in the study will be excluded.'}, 'identificationModule': {'nctId': 'NCT07405918', 'briefTitle': '3D Printed Customized Bone Graft for Alveolar Regeneration: Longitudinal Cohort Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'University of Guarulhos'}, 'officialTitle': '3D Printed Customized Bone Graft for Alveolar Regeneration: Longitudinal Cohort Evaluation', 'orgStudyIdInfo': {'id': 'Guaruhos University'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Clinical evaluation', 'type': 'OTHER', 'description': 'Clinical parmeters and radiographical analysis'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jamil A Shibli, DDS, PhD', 'role': 'CONTACT', 'email': 'jshibli@ung.br', 'phone': '+55 11 982593439'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Guarulhos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jamil awad shibli', 'investigatorAffiliation': 'University of Guarulhos'}}}}