Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2026-01-23 @ 4:50 PM
Study NCT ID:
NCT03757195
Status:
UNKNOWN
Last Update Posted:
2018-11-28
First Post:
2017-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Augmentation of Maxillary Horizontal And Vertical Bone Deficiency Using Mineralized Plasmatic Matrix
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2020-10-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-27', 'studyFirstSubmitDate': '2017-11-27', 'studyFirstSubmitQcDate': '2018-11-27', 'lastUpdatePostDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'amount of bone loss', 'timeFrame': 'change from baseline at 6 months', 'description': 'amount of bone loss after xenograft by CBCT'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mineralized plasmatic matrix', 'sticky bone', 'plasma', 'autogeous fibrin glue'], 'conditions': ['Alveolar Ridge Abnormality of Maxilla']}, 'descriptionModule': {'briefSummary': 'A new technique of grafting introduce called Mineralized plasmatic matrix. This technique can be used in grafting in anterior zone giving a good results and bone substitution occur using allograft or xenograft.\n\nThe bone graft have a good consistency when it mixed with plasma give easy application, strength and stability of the graft. Also plasma rich with CGF (Cellular growth factors).', 'detailedDescription': 'Patients suffering from anterior maxillary vertical and horizontal bone loss will be treated using a xeno-graft mixed with the same patient plasma that extracted from his own blood during the operation this graft will be stabilized by collagen membrane and surgical tags.\n\nPatients will be follow up for 6 months to measure amount of bone loss of the xeno-graft during this period post operative using C.B.C.T'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: from 20 to 40 years old\n* no history of previous grafting.\n* no History of previous implant placement\n* Medically Free e.g no debilitating diseases\n\nExclusion Criteria:\n\n* Smoker patients.\n* Alcoholic patients\n* Pregnant.\n* Drug Abusers.\n* Hypertensive , Diabetic, having Problems or disease in Kidney and/or liver.\n* Thyroid Disease.\n* Problem in Vit.D absorption or in calcitonin hormone secretion.\n* History of blood transfusion or donating blood less than 4 months.\n* Patient under Corticosteroid therapy.\n* Neurologicaly unstable patients.\n* History of radiotherapy or chemo-therapy.\n* Patient undergo Spect C.T Scan less than 4 Months .'}, 'identificationModule': {'nctId': 'NCT03757195', 'briefTitle': 'Augmentation of Maxillary Horizontal And Vertical Bone Deficiency Using Mineralized Plasmatic Matrix', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Augmentation of Maxillary Horizontal And Vertical Bone Deficiency Using Mineralized Plasmatic Matrix', 'orgStudyIdInfo': {'id': 'CEBC-CU-2017-11-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'augmentation by xenograft', 'description': 'xenograft mixed with plasma extracted from blood', 'interventionNames': ['Procedure: Augmentation']}], 'interventions': [{'name': 'Augmentation', 'type': 'PROCEDURE', 'description': 'combination product', 'armGroupLabels': ['augmentation by xenograft']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Hany M Ahmed, BDS', 'role': 'CONTACT', 'email': 'hanyyusf4@gmail.com', 'phone': '00201091971228'}], 'facility': 'Cairo Univerisity', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'status': 'NOT_YET_RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Tarek I. Abdallah, P.H.D', 'role': 'CONTACT'}, {'name': 'Hany M. Ahmed, B.D.S', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Hany M Ahmed, B.D.S', 'role': 'CONTACT', 'email': 'hanyyusf4@gmail.com', 'phone': '00201091971228'}, {'name': 'Tarek I Abdallah, P.H.D', 'role': 'CONTACT', 'email': 't_ghareeb@hotmail.com', 'phone': '01282931864'}], 'overallOfficials': [{'name': 'Tarek I. Abdallah, P.H.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of Oral Surgery in Nahda University', 'investigatorFullName': 'hany mostafa ahmed', 'investigatorAffiliation': 'Cairo University'}}}}