Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT06853392
Status:
COMPLETED
Last Update Posted:
2025-03-03
First Post:
2025-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Socket Preservation Using Dentin Graft Autogenous Dentin Graft With Collagen Sponge on Dental Implant Stability AUTOGENOUS TOOTH GRAFT WITH COLLAGEN SPONGE ON DENTAL IMPLANT STABILITY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001862', 'term': 'Bone Resorption'}], '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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'test group :socket preservation by dentin graft covered with collagen sponge control group :socket preservation by demineralized freeze dried allograft covered by collagen sponge'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2025-02-27', 'studyFirstSubmitQcDate': '2025-02-27', 'lastUpdatePostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in radiographic Socket dimensions from base line to 6 months', 'timeFrame': '6 months following the end of treatment', 'description': 'CBCT measuring socket dimensions'}, {'measure': 'change in bone density from base line to 6 months', 'timeFrame': '6 months following the end of treatment', 'description': 'CBCT measuring bone density within the socket'}], 'secondaryOutcomes': [{'measure': 'new bone formation', 'timeFrame': 'after six months at the time of implant placement', 'description': 'Histological analysis for new bone formation by masson trichrome'}, {'measure': 'implant stability', 'timeFrame': 'after six months at the time of implant placement', 'description': 'measuring primary Implant Stability by resonance frequency analysis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['socket preservation', 'alveolar ridge defect', 'Dentin graft', 'Demineralized freeze dried allograft'], 'conditions': ['Bone Loss', 'Bone Remodeling Disorder', 'Bone Resorption']}, 'descriptionModule': {'briefSummary': 'The present study was performed to evaluate socket preservation using collagen sponge with autogenous dentin graft versus collagen sponge with de-mineralised freez-dried bone graft on dental implant stability', 'detailedDescription': 'in our study we made socket preservation using two different grafts in two groups.\n\nbefore grafting we took CBCT\n\nwe used autogenous dentin graft covered by collagen sponge in one group and demineralized freeze - dried allograft covered with collagen sponge in the other group.\n\nafter 6 months we Took another CBCT to assist the dimensional changes and bone density in the alveolar socket after grafting We inserted the implant and during insertion we took a core biopsy with trephine bur with external diameter 3 mm for histological analysis.\n\nAfter implant insertion we assisted the stability using RFA.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients are free from any systemic diseases.\n* Patients with good oral hygiene.\n* Age range from 25-50 years.\n* Adequate inter arch space .\n\nExclusion Criteria:\n\n* Medications that may affect bone turnover, and bone metabolic diseases.\n* Smoker patients and alcoholics.\n* Patients with parafunctional habits.\n* Patients with active acute infection related to tooth of interest.\n* Patients with a lack of compliance, and serious mental or psychological problems.\n* Pregnant females.'}, 'identificationModule': {'nctId': 'NCT06853392', 'briefTitle': 'Socket Preservation Using Dentin Graft Autogenous Dentin Graft With Collagen Sponge on Dental Implant Stability AUTOGENOUS TOOTH GRAFT WITH COLLAGEN SPONGE ON DENTAL IMPLANT STABILITY', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Faculty of Dental Medicine for Girls'}, 'officialTitle': 'Evaluation of Socket Preservation Using Autogenous Dentin Graft With Collagen Sponge on Dental Implant Stability', 'orgStudyIdInfo': {'id': 'P-ME-23-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'demineralized freeze dried allograft', 'description': 'demineralized freeze dried allograft with collagen sponge', 'interventionNames': ['Combination Product: Demineralized freeze dried allograft with collagen sponge']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'autogenous dentin graft', 'description': 'Autogenous dentin graft with collagen sponge', 'interventionNames': ['Combination Product: autogenous dentin graft with collagen sponge']}], 'interventions': [{'name': 'Demineralized freeze dried allograft with collagen sponge', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['DFDBA'], 'description': 'Demineralized freeze dried allograft,filling 2/3 of the socket covered with collagen sponge ,six months, one time', 'armGroupLabels': ['demineralized freeze dried allograft']}, {'name': 'autogenous dentin graft with collagen sponge', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['ADG'], 'description': 'autogenous mineralized dentin graft, filling 2/3 of the socket covered with collagen sponge , six months, one time', 'armGroupLabels': ['autogenous dentin graft']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'AL Azhar university for girls', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculty of Dental Medicine for Girls', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Beni-Suef University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'teaching assistant', 'investigatorFullName': 'Amira Ali El said', 'investigatorAffiliation': 'Faculty of Dental Medicine for Girls'}}}}