Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-31 @ 5:29 AM
Study NCT ID:
NCT07209618
Status:
COMPLETED
Last Update Posted:
2025-10-07
First Post:
2025-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Horizontal Ridge Augmentation With Simultaneous Implant Placement Using Autogenous Ramus Grafts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016301', 'term': 'Alveolar Bone Loss'}, {'id': 'D016388', 'term': 'Tooth Loss'}], 'ancestors': [{'id': 'D001862', 'term': 'Bone Resorption'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-09-29', 'studyFirstSubmitQcDate': '2025-09-29', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'implant survival rate', 'timeFrame': '4 months post-surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alveolar Bone Loss', 'Tooth Loss / Rehabilitation']}, 'descriptionModule': {'briefSummary': 'This retrospective observational study evaluated the clinical outcomes of simultaneous implant placement with horizontal ridge augmentation using autogenous mandibular ramus block grafts. Sixteen patients were treated between January 2018 and March 2025. Clinical and radiological data were analyzed to assess implant survival, osseointegration, and graft incorporation.', 'detailedDescription': 'Horizontal alveolar bone deficiency is a significant challenge in implant rehabilitation. Traditional staged augmentation techniques prolong treatment time and increase morbidity. This study introduces a novel approach in which autogenous mandibular ramus block grafts were used to reconstruct buccal walls simultaneously with implant placement. Sixteen patients received 23 implants. Outcomes included implant survival, osseointegration success, bone healing, and complications during a mean follow-up of 30.6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Sixteen patients (9 females, 7 males; mean age 41.4 years, range 21-61 years) with horizontal alveolar ridge deficiencies were treated at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Akdeniz University, between January 2018 and March 2025. All patients underwent horizontal ridge augmentation with autogenous mandibular ramus block grafts in conjunction with simultaneous implant placement.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥18 years of age\n* ASA I or II status\n* Presence of horizontal alveolar ridge deficiency requiring augmentation for implant placement\n* Treated with autogenous mandibular ramus block grafts and simultaneous implant placement\n* Provided informed consent for surgical and prosthetic procedures, and use of clinical and radiological data\n\nExclusion Criteria:\n\n* Systemic conditions interfering with dental implant treatment (e.g., uncontrolled diabetes, metabolic bone disease)\n* Incomplete clinical or radiological records\n* Patients with contraindications for oral surgical procedures\n* Patients unwilling to provide informed consent'}, 'identificationModule': {'nctId': 'NCT07209618', 'briefTitle': 'Horizontal Ridge Augmentation With Simultaneous Implant Placement Using Autogenous Ramus Grafts', 'organization': {'class': 'OTHER', 'fullName': 'Akdeniz University'}, 'officialTitle': 'Rehabilitation of Alveolar Horizontal Bone Deficiencies Using Autogenous Onlay Bone Grafting With Simultaneous Implant Placement: A Novel Approach', 'orgStudyIdInfo': {'id': 'AKDENIZ-RAMUS-2018-TBAEK-415'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Simultaneous implant + ramus graft group', 'interventionNames': ['Procedure: utogenous mandibular ramus block grafting with simultaneous dental implant placement', 'Procedure: Autogenous mandibular ramus block graft with simultaneous implant placement']}], 'interventions': [{'name': 'utogenous mandibular ramus block grafting with simultaneous dental implant placement', 'type': 'PROCEDURE', 'description': 'Horizontal alveolar ridge augmentation performed using autogenous block grafts harvested from the mandibular ramus. The graft was fixed to reconstruct the buccal wall, followed by immediate placement of dental implants in the same surgical session. Prosthetic loading was initiated 4 months postoperatively.', 'armGroupLabels': ['Simultaneous implant + ramus graft group']}, {'name': 'Autogenous mandibular ramus block graft with simultaneous implant placement', 'type': 'PROCEDURE', 'description': 'Horizontal alveolar ridge augmentation performed using autogenous block grafts harvested from the mandibular ramus. The graft was fixed to reconstruct the buccal wall, followed by immediate placement of dental implants in the same surgical session. Prosthetic loading was initiated 4 months postoperatively.', 'armGroupLabels': ['Simultaneous implant + ramus graft group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07070', 'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Akdeniz University', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}], 'overallOfficials': [{'name': 'Ozalp', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Akdeniz University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akdeniz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Oznur Ozalp', 'investigatorAffiliation': 'Akdeniz University'}}}}