Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-01-11 @ 1:01 AM
Study NCT ID:
NCT03175458
Status:
UNKNOWN
Last Update Posted:
2017-06-05
First Post:
2017-05-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Schnederian Membrane Elevation and Augmentation With Deproteinized Bovine Bone [Tutu-gen Bone] Versus Graft Less Tenting Technique With Simultaneous Implant Placement
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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-01', 'studyFirstSubmitDate': '2017-05-17', 'studyFirstSubmitQcDate': '2017-06-01', 'lastUpdatePostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patient satisfaction', 'timeFrame': '7 days post operative', 'description': 'evaluation of post operative complications in terms of pain and edema using patient pain chart'}], 'secondaryOutcomes': [{'measure': 'implant stability', 'timeFrame': 'will be measured intraoperatively immediately after insertion of the implants and will be measure one more time 6 months after the 1st operation at the time of exposure of the implants', 'description': 'measurement of the implant stability using the osstell device'}, {'measure': 'height of bone gained or lost around the implants', 'timeFrame': '6 months postoperative', 'description': 'two cone beam computed tomography(CBCT) will be taken for the patient, one immediate postoperative and the other 6 months after the operation then the height of bone gained or lost around the implants will be assessed by superimposing the same section in the two CBCTS.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tenting', 'grafting', 'implant placement'], 'conditions': ['Maxillary Sinus Floor Elevation']}, 'descriptionModule': {'briefSummary': '30 recruited patients indicated for sinus membrane elevation with simultaneous implant placement. patients are divided into 2 groups each group contain 15 patients, one group assigned for placement of bovine bone graft after membrane elevation and insertion of the implants while the other group assigned for graft-less tenting technique after membrane elevation and insertion of the implant.', 'detailedDescription': 'On the 2 groups a mucoperiosteal flap is elvated then a lateral wondow is created then sinus membrane is elevated then the implants are placed, in the control group deproteinized bovine bone graft substitute is placed in the sinus for augmentation while in the study group no bone graft is added inside the sinus( graftless tenting technique)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with atrophic maxilla and pneumatization of the maxillary sinus with residual bone height at least 5mm as per MISCH criteria.\n* both sexes.\n\nExclusion Criteria:\n\n* sinus pathology\n* heavy smokers(more than 20 cigarettes per day.\n* patients with systemic disease that may affect normal healing.'}, 'identificationModule': {'nctId': 'NCT03175458', 'briefTitle': 'Schnederian Membrane Elevation and Augmentation With Deproteinized Bovine Bone [Tutu-gen Bone] Versus Graft Less Tenting Technique With Simultaneous Implant Placement', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Schnederian Membrane Elevation and Augmentation With Deproteinized Bovine Bone [Tutu-gen Bone] Versus Graft Less Tenting Technique With Simultaneous Implant Placement: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'cebc.cu'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sinus lift,implant placement,tenting', 'description': 'elevation of the sinus membrane with simultaneous implant placement without the use of any bone graft material(tenting technique)', 'interventionNames': ['Procedure: sinus lift,implant placement,tenting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sinus lift,implant placement,bovine bone', 'description': 'elevation of the sinus membrane with simultaneous implant placement together with deproteinized bovine bone graft substitute for augmentation', 'interventionNames': ['Procedure: sinus lift,implant placement,bovine bone']}], 'interventions': [{'name': 'sinus lift,implant placement,tenting', 'type': 'PROCEDURE', 'description': 'elevation of the sinus membrane then insertion of the implants without any bone graft material( graft-less) for augmentation', 'armGroupLabels': ['sinus lift,implant placement,tenting']}, {'name': 'sinus lift,implant placement,bovine bone', 'type': 'PROCEDURE', 'description': 'sinus membrane elevation then placement of the implants together with deproteinized bovine bone substitute as a graft material for augmentation', 'armGroupLabels': ['sinus lift,implant placement,bovine bone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Dentistry Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Waleed Fouad Mahmoud', 'investigatorAffiliation': 'Cairo University'}}}}