Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-06 @ 6:49 AM
Study NCT ID:
NCT07394933
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-18
First Post:
2026-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Guided Bone Regeneration Using Ti-Reinforced PTFE Membrane Vs. Khoury's Technique in Augmentation of Posterior Mandibular Defects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-15', 'studyFirstSubmitDate': '2026-01-31', 'studyFirstSubmitQcDate': '2026-01-31', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cone Beam Volumetric Topography (CBVT)', 'timeFrame': '6 Months'}], 'secondaryOutcomes': [{'measure': 'Clinical measurement: the frequency of complications', 'timeFrame': '6 Months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrophic Ridge']}, 'descriptionModule': {'briefSummary': 'The aim of the present clinical trial is to compare two different alveolar ridge bone augmentation techniques for mandibular horizontal bone defects.', 'detailedDescription': "Will using PTFE membrane with a mixture of xenograft and particulate autogenous bone result in bone gain similar to standard Khoury's bone shell technique?"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Have one or more missing teeth in the posterior mandibular segment.\n2. The alveolar ridge in the edentulous site of the selected patients will have a buccolingual width of less than 5 mm.\n3. Sufficient vertical bone height above inferior alveolar nerve.\n4. Free of any local or systemic condition that may contraindicate ridge expansion procedure.\n5. No sex predilection.\n6. The patient will be between the ages of 18-70 years.\n\nExclusion Criteria:\n\n1. Patients taking any medication that may interfere with bone healing or bone biology.\n2. Patients with any systemic disease that may affect bone healing.\n3. Any patients with any previous bone grafting procedure at the site of interest.\n4. Heavy Smokers (more than 20 cigarettes daily).\n5. Patient's that have been diagnosed with periodontal disease, as sufficient ridge height would be improbable."}, 'identificationModule': {'nctId': 'NCT07394933', 'briefTitle': "Guided Bone Regeneration Using Ti-Reinforced PTFE Membrane Vs. Khoury's Technique in Augmentation of Posterior Mandibular Defects", 'organization': {'class': 'OTHER', 'fullName': 'British University In Egypt'}, 'officialTitle': "Guided Bone Regeneration Using Ti-Reinforced PTFE Membrane Vs. Khoury's Technique in Augmentation of Posterior Mandibular Defects", 'orgStudyIdInfo': {'id': '25-019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': "Khoury's bone shell technique", 'description': 'Bone blocks will be harvested from the retromolar area after measuring of the size required and measuring of the donor site anatomy. Piezoelectric device will be used to perform the graft osteotomy. The block size should be slightly larger than the defect size. Sharp bony edges will be smoothened, and the donor defect will be packed with gelatin sponges. The bone block margins will be smoothened and separated into two thinner bone shells using titanium disk with copious saline irrigation. The blocks will be fixed into the recipient site buccally using at least two micro-screws leaving a gap to be filled with bone graft.', 'interventionNames': ["Procedure: Khoury's bone shell technique"]}, {'type': 'EXPERIMENTAL', 'label': 'GBR using Ti-reinforced PTFE Membrane', 'description': 'A non-resorbable ti-enforced polytetrafluoroethylene (PTFE) membrane will be fixed with titanium screws on the lingual bone plate and on the buccal bone plate allowing for packing of particulate mix of bone graft (50% Xenograft: 50% Autogenous graft).', 'interventionNames': ['Procedure: GBR using Ti-reinforced PTFE Membrane']}], 'interventions': [{'name': "Khoury's bone shell technique", 'type': 'PROCEDURE', 'description': 'Bone blocks will be harvested from the retromolar area after measuring of the size required and measuring of the donor site anatomy. Piezoelectric device will be used to perform the graft osteotomy. The block size should be slightly larger than the defect size. Sharp bony edges will be smoothened, and the donor defect will be packed with gelatin sponges. The bone block margins will be smoothened and separated into two thinner bone shells using titanium disk with copious saline irrigation. The blocks will be fixed into the recipient site buccally using at least two micro-screws leaving a gap to be filled with bone graft.', 'armGroupLabels': ["Khoury's bone shell technique"]}, {'name': 'GBR using Ti-reinforced PTFE Membrane', 'type': 'PROCEDURE', 'description': 'A non-resorbable ti-enforced polytetrafluoroethylene (PTFE) membrane will be fixed with titanium screws on the lingual bone plate and on the buccal bone plate allowing for packing of particulate mix of bone graft (50% Xenograft: 50% Autogenous graft).', 'armGroupLabels': ['GBR using Ti-reinforced PTFE Membrane']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Dentistry - The British University in Egypt', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'British University In Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ahmed Hassan El-Zaher', 'investigatorAffiliation': 'British University In Egypt'}}}}