Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-26 @ 3:24 PM
Study NCT ID:
NCT07086859
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-25
First Post:
2025-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alveolar Ridge Preservation Using Autogenous Whole Tooth Graft With 1 %Metformin :A Randomized Controlled Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The patients participating in this clinical trial'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Clinical Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2025-07-18', 'studyFirstSubmitQcDate': '2025-07-18', 'lastUpdatePostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographic buccolingual width ridge loss', 'timeFrame': '6 months', 'description': 'Measuring the CBCT these dimensions pre operative and after 6 months'}], 'secondaryOutcomes': [{'measure': 'Alveolar buccal ridge height, lingual ridge height', 'timeFrame': '6 months', 'description': 'Measuring them on CBCT pre operative and after 6 months'}, {'measure': 'the area percentage of newly formed bone, soft tissue and residual graft', 'timeFrame': '6 months', 'description': 'By Histology after taking a biopsy after 6 months'}, {'measure': 'Patient satisfaction evaluation', 'timeFrame': '2 weeks', 'description': 'by visual analog scale (0-10)'}, {'measure': 'Total number of analgesics taken in the first week', 'timeFrame': '1 week', 'description': 'by asking the patient'}, {'measure': 'Socket wound healing score', 'timeFrame': '2 weeks', 'description': 'by taking occlusal clinical pictures of socket'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alveolar ridge preservation', 'socket preservation', 'Autogenous Whole tooth Graft', 'AWTG', 'Tooth grafting', 'tooth extraction', 'bone graft'], 'conditions': ['Dimensional Changes After Tooth Extraction', 'Tooth Extraaction', 'Socket Preservation']}, 'referencesModule': {'references': [{'pmid': '33565656', 'type': 'BACKGROUND', 'citation': 'Elfana A, El-Kholy S, Saleh HA, Fawzy El-Sayed K. Alveolar ridge preservation using autogenous whole-tooth versus demineralized dentin grafts: A randomized controlled clinical trial. Clin Oral Implants Res. 2021 May;32(5):539-548. doi: 10.1111/clr.13722. Epub 2021 Mar 1.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.21608/ajdsm.2021.66398.1181', 'label': 'Related Info'}, {'url': 'https://doi.org/10.1097/SCS.0000000000004263', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study describes a technique used to preserve the bone dimensions after the tooth extraction inorder to facilitate later on the dental implant placement', 'detailedDescription': 'Socket preservation by type of graft used from the tooth combined with Metformin to enhace the results of the bone formation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* patients requiring single extraction of non-molar tooth\n* extraction sockets having more than 50% buccal alveolar bone loss\n\nExclusion Criteria:\n\n* Pregnancy\n* smokers\n* patients not maintaing good oral hygiene\n* presernce of acute endodontic infection in the tooth to be ectracted\n* medical conditions hindering implant placement\n* uncontrolled diabetes\n* Immune suppression\n* bisphosphanates'}, 'identificationModule': {'nctId': 'NCT07086859', 'briefTitle': 'Alveolar Ridge Preservation Using Autogenous Whole Tooth Graft With 1 %Metformin :A Randomized Controlled Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Alveolar Ridge Preservation Using Autogenous Whole Tooth Graft With 1 %Metformin :A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '279'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test', 'description': 'Autogenous Whole tooth graft + Metformin in the socket of extracted non-molar tooth', 'interventionNames': ['Procedure: TEST 1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Autogenous whole tooth graft', 'interventionNames': ['Procedure: Control']}], 'interventions': [{'name': 'TEST 1', 'type': 'PROCEDURE', 'description': 'Autogenous whole tooth graft with metformin', 'armGroupLabels': ['Test']}, {'name': 'Control', 'type': 'PROCEDURE', 'description': 'Autogenous whole tooth graft', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'contacts': [{'name': 'Nada Gadallah, Masters Degree Candidate', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cairo Univeristy', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Nada Gadallah, Masters Degree Candidate', 'role': 'CONTACT', 'email': 'nada.gadallah@dentistry.cu.edu.eg', 'phone': '+201000130279'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Masters Degree Candidate', 'investigatorFullName': 'Nada Mohamed Hassan Gadallah', 'investigatorAffiliation': 'Cairo University'}}}}