Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT06134869
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2023-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open Membrane Technique as an Innovative Minimally Invasive Technique
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': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-15', 'studyFirstSubmitDate': '2023-08-10', 'studyFirstSubmitQcDate': '2023-11-15', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hard tissue gain', 'timeFrame': '5 months', 'description': 'Bone thickness measured clinically and on CBCT (during bone grafting and at re-entry)'}], 'secondaryOutcomes': [{'measure': 'Soft tissue gain', 'timeFrame': '5 months', 'description': 'Keratinized tissue measured clinically before and after the treatment (at implant placement)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Graft', 'Keratinized Tissue']}, 'descriptionModule': {'briefSummary': 'Sixteen patients with horizontal deficiencies in the posterior mandible were treated with "the Open Membrane Technique" (OMT). Dense PTFE membranes covering an allograft biomaterial were used without any attempt to passivate the flap. Flap closure with an open wound (membrane exposure) was monitored weekly for up to 6w at the time of membrane removal. At implant placement, soft and hard tissue gains were assessed clinically and radiographically. Bone cores were harvested for histological analysis from the implant preparation sites'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults\n* Free of any systemic disease affecting bone metabolism\n* Highly compliant\n* Good oral hygiene\n* Willing to sign informed consents prior to their inclusion\n\nExclusion Criteria:\n\n* Untreated periodontal disease\n* Heavy smokers\n* Excessive alcohol consumption\n* Uncontrolled systemic conditions'}, 'identificationModule': {'nctId': 'NCT06134869', 'briefTitle': 'Open Membrane Technique as an Innovative Minimally Invasive Technique', 'organization': {'class': 'OTHER', 'fullName': 'Saint-Joseph University'}, 'officialTitle': 'Open Membrane Technique as an Innovative Minimally Invasive Technique for Hard and Soft Tissue Augmentation: a Prospective Case Series', 'orgStudyIdInfo': {'id': 'USJ-2023-241'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients requiring horizontal bone augmentation in the posterior mandible', 'interventionNames': ['Procedure: Bone augmentation']}], 'interventions': [{'name': 'Bone augmentation', 'type': 'PROCEDURE', 'description': 'Dense PTFE membranes covering an allograft biomaterial were used without any attempt to passivate the flap', 'armGroupLabels': ['Patients requiring horizontal bone augmentation in the posterior mandible']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'state': 'Ashrafieh', 'country': 'Lebanon', 'facility': 'Clinic 506', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'The data are available at any time', 'ipdSharing': 'YES', 'description': 'Any data will be shared with other researches if it is required or will help conducting further studies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint-Joseph University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Abdel Rahman Kassir', 'investigatorAffiliation': 'Saint-Joseph University'}}}}