Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2026-01-02 @ 6:29 AM
Study NCT ID:
NCT03628157
Status:
UNKNOWN
Last Update Posted:
2018-08-14
First Post:
2018-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GBR With Ptfe With Bovine Bone With and Without Autogenous
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-13', 'studyFirstSubmitDate': '2018-08-07', 'studyFirstSubmitQcDate': '2018-08-13', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of bone gain (height and width in mm)', 'timeFrame': '6 months', 'description': 'will be measured using linear measurements from CBCT'}], 'secondaryOutcomes': [{'measure': 'a bone sample will be collected and analyzed under histo-morphometric analysis. (no of bone cells in cubic mm)', 'timeFrame': '6 months', 'description': 'a bone sample will be collected and analyzed under histo-morphometric analysis.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrophied Anterior Maxillary Ridges']}, 'descriptionModule': {'briefSummary': 'Ridge Augmentation in Atrophic Anterior Maxillary Ridges with a Titanium Reinforced Polytetraflouroethelene Membrane and Anorganic Bovine Bone-Derived Mineral in intervention group and Anorganic Bovine Bone-Derived Mineralwith Particulated Autogenous Bone Chips in control group.\n\nCBCT will be done before surgery, immediate after surgery and 6 month to compare the bone gain in mm.\n\nBone sample will be collected during exposure after 6 month of surgery by trephine bur to assess the bone quality through histo-morphometric analysis in order to determine the size, shape and orientation of the bony trabeculae, the size and porosity of the bony cortex in addition to the new bone/ bone substitute ratio\n\n* 1ry outcome: Amount of bone gain will be measured using linear measurements from CBCT immediate after surgery and after 6 month.\n* 2ry outcome: a bone sample will be collected and analyzed under histo-morphometric analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Patients with atrophied anterior maxillary ridge area.\n\n * Age: 18 years and older.\n * Both sexes.\n * No intraoral soft and hard tissue pathology.\n * No systemic condition that contraindicate bone augmentation\n\nExclusion Criteria:\n\n* • Heavy smokers more than 20 cigarettes per day.(32)\n\n * Patients with systemic disease that may affect normal healing.\n * Psychiatric problems.\n * Disorders to bone augmentation are related to history of radiation therapy to the head and neck neoplasia.\n * Pregnant or nursing women.\n * Patients with uncontrolled diabetes mellitus, rheumatoid arthritis or osteoporosis.\n * Patient with previous history of radiotherapy.'}, 'identificationModule': {'nctId': 'NCT03628157', 'briefTitle': 'GBR With Ptfe With Bovine Bone With and Without Autogenous', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Ridge Augmentation in Atrophic Anterior Maxillary Ridges With a Titanium Reinforced Polytetraflouroethelene Membrane and Anorganic Bovine Bone-Derived Mineral With and Without Particulated Autogenous Bone Chips', 'orgStudyIdInfo': {'id': 'Bone augmentation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'using a bio-oss bovine bone alone', 'interventionNames': ['Other: Geistlich Bio-Oss® bovine bone alone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'using a bio-oss bovine bone with autogenous bone ratio 1:1', 'interventionNames': ['Other: Geistlich Bio-Oss® bovine bone alone']}], 'interventions': [{'name': 'Geistlich Bio-Oss® bovine bone alone', 'type': 'OTHER', 'description': 'Ridge augmentation by titanium reinforced polytetraflouroethelene membrane and anorganic bovine bone derived mineral alone', 'armGroupLabels': ['control', 'intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12613', 'city': 'Giza', 'country': 'Egypt', 'contacts': [{'name': 'hassan A ahmed, bachelor', 'role': 'CONTACT', 'email': 'hassan.ahmed@dentistry.cu.edu.eg', 'phone': '(+202) 23642938'}], 'facility': 'Faculty of Oral and Dental Medicine', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'sherif hegazy, bachelor', 'role': 'CONTACT', 'email': 'shekosoa@gmail.com', 'phone': '00201008183867'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Sherif osama hegazy', 'investigatorAffiliation': 'Cairo University'}}}}