Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT04376320
Status:
COMPLETED
Last Update Posted:
2020-11-04
First Post:
2020-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Two Pre-prosthetic Surgical Techniques for Augmentation of Mandibular Vertical Ridge Defects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-02', 'studyFirstSubmitDate': '2020-04-29', 'studyFirstSubmitQcDate': '2020-05-01', 'lastUpdatePostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean percentage of change of alveolar bone height', 'timeFrame': '6 months', 'description': 'change of alveolar bone height after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alveolar Ridge Enlargement']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare two pre-prosthetic surgical techniques for augmentation of vertical mandibular ridge defects in preparation for implant placement, the first using customized ceramic membranes and the second using tenting titanium screws in conjunction with particulate bone graft and collagen membrane (modified sausage technique).', 'detailedDescription': 'Background: Expansion of the periosteum and soft tissue matrix by tenting has been described as a method of Guided Bone Regeneration (GBR) for reconstruction of atrophic alveolar ridges.\n\nMaterials and Methods: The current study is a prospective controlled clinical trial, conducted on 14 patients, having about 7 mm of vertical bone height in the posterior mandible above the inferior alveolar canal. They are divided into 2 equal groups, each consisting of 7 patients. The first group receives customized ceramic membranes with a vertical height 5 mm above the crest of the ridge to tent out the soft tissue matrix, while in the second group, tenting of the soft tissue is done by fixation of two tenting screws, particulate bone graft is packed then covered by collagen membrane that is fixed by bone tacks (modified sausage technique).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients of both genders\n* with age range from 40 to 60 years,\n* having about 7 mm of vertical bone height in the posterior mandible above the inferior alveolar canal and\n* requiring prosthetic rehabilitation with dental implants.\n\nExclusion Criteria:\n\n* heavy smokers,\n* patients undergoing radiotherapy or chemotherapy,\n* those having infection or local lesions in the area of surgery, and\n* patients with bone diseases which may compromise the results'}, 'identificationModule': {'nctId': 'NCT04376320', 'briefTitle': 'Comparison of Two Pre-prosthetic Surgical Techniques for Augmentation of Mandibular Vertical Ridge Defects', 'organization': {'class': 'OTHER', 'fullName': 'University of Alexandria'}, 'officialTitle': 'Comparison of Two Pre-prosthetic Surgical Techniques for Augmentation of Mandibular Vertical Ridge Defects', 'orgStudyIdInfo': {'id': 'UAlexandriaDentSurg'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1(ceramic membrane)', 'description': 'using customized ceramic membranes for augmentation of vertical mandibular ridge defects in preparation for implant placement', 'interventionNames': ['Device: customised ceramic sheets (Group 1)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2 (modified sausage technique)', 'description': 'using tenting titanium screws in conjunction with particulate bone graft and collagen membrane (modified sausage technique) for augmentation of vertical mandibular ridge defects in preparation for implant placement', 'interventionNames': ['Combination Product: modified sausage technique (Group 2)']}], 'interventions': [{'name': 'customised ceramic sheets (Group 1)', 'type': 'DEVICE', 'description': 'guided bone regeneration', 'armGroupLabels': ['Group 1(ceramic membrane)']}, {'name': 'modified sausage technique (Group 2)', 'type': 'COMBINATION_PRODUCT', 'description': 'guided bone regeneration', 'armGroupLabels': ['Group 2 (modified sausage technique)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21411', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Dentistry', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lydia Nabil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Oral and Maxillofacial Surgery', 'investigatorFullName': 'Lydia Nabil', 'investigatorAffiliation': 'University of Alexandria'}}}}