Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-02 @ 1:45 PM
Study NCT ID:
NCT06773104
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-14
First Post:
2024-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autogenous Tooth Bone Graft Versus Allogeneic Bone Graft Around Dental Implant in Aesthetic Zone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014180', 'term': 'Transplantation'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'non restorable anterior teeth with thin labial plate of bone'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-06-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-12', 'studyFirstSubmitDate': '2024-12-30', 'studyFirstSubmitQcDate': '2025-01-12', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'labial bone thickness', 'timeFrame': '6 months', 'description': 'measuring thickness of labial bone labial to the implant'}, {'measure': 'marginal bone loss', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'bone density around dental implant', 'timeFrame': '6 months', 'description': 'bone density will be assessed using CBCT buccal to the implant fixtures 6 months after implant installation'}, {'measure': 'implant secondary stability', 'timeFrame': '6 months', 'description': 'Implant stability will be assessed at the time of implant insertion and 6 months after the operation. Resonance frequency analysis (RFA) values expressed as implant stability quotient (ISQ) will be recorded by a transducer attached to the implant by a screw and a frequencyresponse analyzer (Osstell Mentor Device) with the average of 2measurements performed with the probe in 2 perpendiculardirections'}, {'measure': 'implant success', 'timeFrame': '6 months', 'description': 'when the following clinical features arise: emerging of the fistula, the particle of the bone graft material flow out from the fistula or mucosal dehiscence, and the chronic inflammation ragarded as failure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['autogenous tooth bone graft', 'allogenic bone graft', 'grafting the jumbing gap', 'immediate dental implant'], 'conditions': ['Immediate Dental Implants', 'Thin Labial Plate of Bone Pre-extraction', 'Hopeless Tooth in Esthetic Zone']}, 'descriptionModule': {'briefSummary': '24 patienta with non restorable anterior teeth underwent extraction with immediate implant installation using bone grafts either autogenous tooth bone graft or allogenic bone graft Autogenous tooth bone graft group (study group): 12 patients will have immediate implant placement with autogenous tooth bone graft.\n\n• Allogeneic bone graft group (control group): 12 patients will have immediate implant placement with allogeneic bone graft (demineralized freeze dried bone allograft - cortico cancellous).', 'detailedDescription': '24 patienta with non restorable anterior teeth underwent extraction with immediate implant installation randomized to two groups Autogenous tooth bone graft group (study group): 12 patients will have immediate implant placement with autogenous tooth bone graft.\n\n• Allogeneic bone graft group (control group): 12 patients will have immediate implant placement with allogeneic bone graft (demineralized freeze dried bone allograft - cortico cancellous).\n\npreparation of autogenous tooth bone graft Any restorations, caries, cementum, periodontal ligament and pulp tissue will be removed .The tooth will be grinded using dental bone mill and bone crusher Tooth particles will be sieved to particles size 300 to 1200 microns. The sorted particles will be immersed in 70 % ethanol and 5% Peracetic acid\\* in a sterile container for 10 minutes to remove any soft tissue remnants, bacteria and smear layer (defatting and sterilization).\n\nTooth particles will be demineralized using 2% HNO3for 20 minutes to expose the dentine organic matrix.\n\nThe bacteria-free particulate dentin will be washed with phosphate buffered saline‡ twice for 5 minutes to restore the PH balance to 7.4. In the same setting, surgical procedure after atraumatic extraction immediate implant willbe inserted according to dimensions taken from CBCT and jumbing gap will be filled with bone graft according to randomization'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with non restorable maxillary anterior teeth need to be extracted.\n\n* Thin labial plate of bone of the tooth to be extracted.\n* Patients age above 20years old.\n* Good oral hygiene.\n* No signs of acute infection or inflammation\n\nExclusion Criteria:\n\n* Prior radiation therapy.\n* Soft and hard tissue pathology at the operation site.\n* Any relevant systemic disease or medication that might compromise bone healing.'}, 'identificationModule': {'nctId': 'NCT06773104', 'briefTitle': 'Autogenous Tooth Bone Graft Versus Allogeneic Bone Graft Around Dental Implant in Aesthetic Zone', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Autogenous Tooth Bone Graft Versus Allogeneic Bone Graft Around Dental Implant in Aesthetic Zone', 'orgStudyIdInfo': {'id': 'diab123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '• Autogenous tooth bone graft group (study group): 12 patients will have immediate implant placement', 'description': '• Autogenous tooth bone graft group (study group): 12 patients will have immediate implant placement preparation of autogenous tooth bone graft : Any restorations, caries, cementum, periodontal ligament and pulp tissue will be removed .The tooth will be grinded using dental bone mill and bone crusher (bone graft kit Tooth particles will be sieved to particles size 300 to 1200 microns. The sorted particles will be immersed in 70 % ethanol and 5% Peracetic acid\\* in a sterile container for 10 minutes to remove any soft tissue remnants, bacteria and smear layer (defatting and sterilization).\n\nTooth particles will be demineralized using 2% HNO3‡ for 20 minutes to expose the dentine organic matrix.\n\nThe bacteria-free particulate dentin will be washed with phosphate buffered saline‡ twice for 5 minutes to restore the PH balance to 7.4. In the same setting, after atraumatic extraction immediate implant inserted and juming gap will be filled with autogenous tooth bone graft', 'interventionNames': ['Procedure: immediate implant and grafting with autogenous tooth bone graft']}, {'type': 'EXPERIMENTAL', 'label': '• Allogeneic bone graft group (control group', 'description': '• Allogeneic bone graft group (control group): 12 patients will have immediate implant placement with allogeneic bone graft (demineralized freeze dried bone allograft - cortico cancellous).\n\nafter atraumatic extraction and immediate implant insertion jumbing gap will be filled with allogenic bone graft', 'interventionNames': ['Procedure: immediate implant with allogenic bone graft']}], 'interventions': [{'name': 'immediate implant and grafting with autogenous tooth bone graft', 'type': 'PROCEDURE', 'description': 'In autogenous tooth bone graft group:\n\nAny restorations, caries, cementum, periodontal ligament and pulp tissue will be removed .The tooth will be grinded using dental bone mill and bone crusher Tooth particles will be sieved to particles size 300 to 1200 microns. The sorted particles will be immersed in 70 % ethanol and 5% Peracetic acid\\* in a sterile container for 10 minutes to remove any soft tissue remnants, bacteria and smear layer (defatting and sterilization).\n\nTooth particles will be demineralized using 2% HNO3‡ for 20 minutes to expose the dentine organic matrix.\n\nThe bacteria-free particulate dentin will be washed with phosphate buffered saline‡ twice for 5 minutes to restore the PH balance to 7.4. In the same setting, after atraumatic extraction immediate implant will be inserted with graft', 'armGroupLabels': ['• Autogenous tooth bone graft group (study group): 12 patients will have immediate implant placement']}, {'name': 'immediate implant with allogenic bone graft', 'type': 'PROCEDURE', 'description': 'after atraumatic extraction immediate implant will be inserted with allogenic bone graft', 'armGroupLabels': ['• Allogeneic bone graft group (control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3111', 'city': 'Tanta', 'country': 'Egypt', 'facility': 'Faculty of Dentistry', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'diab abdelgaied diab, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of dentistry tanta university'}, {'name': 'Rafic ramadan bedir, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of dentistry tanta university'}, {'name': 'Ibrahim mohammed nowair, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of dentistry tanta university'}, {'name': 'Mona samy sheta, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of dentistry tanta university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Diab Abdel Gaied Diab Ghanem Mohammed', 'investigatorAffiliation': 'Tanta University'}}}}