Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT05020405
Status:
COMPLETED
Last Update Posted:
2023-07-18
First Post:
2021-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Simvastatin With Guided Bone Regeneration in Ridge Splitting and Simultaneously Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C039746', 'term': '4-azido-2-nitrophenyluridylyl pyrophosphate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-17', 'studyFirstSubmitDate': '2021-08-18', 'studyFirstSubmitQcDate': '2021-08-18', 'lastUpdatePostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurements of the amount of bone formation in millimeters around immediately placed dental implants', 'timeFrame': '9 months', 'description': 'Measurements of the amount of bone formation in millimeters using GBR with or without the combined effect of SMV in the ridge splitting following immediate implant placement.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ridge Splitting', 'Simvastatin', 'Immediate Implant']}, 'referencesModule': {'references': [{'pmid': '38172458', 'type': 'DERIVED', 'citation': 'Issa DR, Elamrousy W, Gamal AY. Alveolar ridge splitting and simvastatin loaded xenograft for guided bone regeneration and simultaneous implant placement: randomized controlled clinical trial. Clin Oral Investig. 2024 Jan 4;28(1):71. doi: 10.1007/s00784-023-05427-y.'}]}, 'descriptionModule': {'briefSummary': 'Ridge split augmentation technique, with immediate implant placement, reduces the time of the treatment and the time of the final prosthetic reconstruction. Furthermore, compression of the bone increases its density. SMV is also found to promote osteogenic differentiation of bone marrow stem cells, suppress osteoclastic differentiation in bone tissue, and promotes osseointegration around implants in animal studies. The aim of this study is to compare surgical outcomes of the application of the alveolar ridge splitting (ARS) in combination with guided bone regeneration (GBR) using bone grafting and a barrier membrane, associated with immediate implant placement versus ARS in combination with the use of SMV with GBR using bone grafting and a barrier membrane, associated with immediate implant placement in patients with horizontally atrophic jaw bones.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* good general health at the time of surgery.\n* at least 3 months of healing after tooth extraction.\n* horizontally compromised alveolar ridges at least 10 mm high and 3 mm wide.\n\nExclusion Criteria:\n\n* a vertical bone defect in the edentulous ridge.\n* thick cortex in the labial/buccal with less cancellous bone inside\n* obvious undercut on the labial/buccal side.\n* uncontrolled periodontal conditions or other oral disorders.\n* history of radiotherapy in the head and neck region.\n* uncontrolled diabetes mellitus or other systematic disorders.\n* smokers.\n* Pregnancy.\n* non-compliant patients.\n* allergic reaction to the medications used.'}, 'identificationModule': {'nctId': 'NCT05020405', 'briefTitle': 'The Effect of Simvastatin With Guided Bone Regeneration in Ridge Splitting and Simultaneously Implantation', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'The Effect of Simvastatin With Guided Bone Regeneration on Ridge Volume in Ridge Splitting and Simultaneously Implantation: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'KFSIRB200- 22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ARS with GBR and SMV', 'description': 'alveolar ridge splitting in combination with the use of GBR with SMV with immediate implant placement', 'interventionNames': ['Procedure: Immediate implant placement and ARS with GBR and SMV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'alveolar ridge splitting with GBR', 'description': 'alveolar ridge splitting in combination with the use of GBR without SMV with immediate implant placement', 'interventionNames': ['Procedure: Immediate implant placement and ARS with GBR']}], 'interventions': [{'name': 'Immediate implant placement and ARS with GBR and SMV', 'type': 'PROCEDURE', 'description': 'Implant insertion and GBR for augmentation of the gap between buccal and lingual plate using bone graft mixed with SMV', 'armGroupLabels': ['ARS with GBR and SMV']}, {'name': 'Immediate implant placement and ARS with GBR', 'type': 'PROCEDURE', 'description': 'Implant insertion and GBR for augmentation of the gap between buccal and lingual plate', 'armGroupLabels': ['alveolar ridge splitting with GBR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33511', 'city': 'Kafr ash Shaykh', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Kafrelsheikh University', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}], 'overallOfficials': [{'name': 'Dalia R Issa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kafrelsheikh University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Dalia Rasheed Issa', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}