Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-01-03 @ 3:17 AM
Study NCT ID:
NCT07272694
Status:
COMPLETED
Last Update Posted:
2025-12-09
First Post:
2025-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Split Crest Procedure: Is It Necessary to Fill the Gap?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-11-26', 'studyFirstSubmitQcDate': '2025-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in alveolar ridge width following split crest proceduree with or without bone or dentin grafting', 'timeFrame': 'Preoparative, Immediately postoperative, and 3 months after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alveolar Bone Resorption', 'Alveolar Bone Grafting', 'Bone Expansion']}, 'descriptionModule': {'briefSummary': 'This prospective controlled clinical study evaluates the effectiveness of adding bone graft or dentin graft material during the split crest (alveolar ridge splitting) procedure for horizontal ridge augmentation with simultaneous implant placement.\n\nThe study includes patients with narrow alveolar ridges requiring implant-supported rehabilitation. Participants are divided into three groups: split crest without grafting, split crest with bone graft, and split crest with dentin graft. The aim is to determine whether the addition of graft material to the osteotomy gap improves bone width, bone density, and primary implant stability compared to the split crest technique alone.\n\nClinical and radiographic assessments are performed using cone-beam computed tomography (CBCT) and implant stability measurements (ISQ values) before surgery, immediately after implant placement, and three months postoperatively. All patients are monitored over a one-year follow-up period to evaluate healing progression and treatment outcomes.\n\nThis study seeks to identify the most effective approach for horizontal ridge augmentation and to improve clinical decision-making in implant dentistry. The findings aim to contribute to optimizing surgical protocols, enhancing implant stability, and improving long-term functional outcomes for patients.\n\nParticipation is voluntary, and all procedures are conducted in accordance with approved ethical standards and clinical guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients aged 18-65 years\n* Indication for tooth extraction in posterior mandibular region with planned implant placement\n* Presence of post-extraction alveolar bone defect requiring ridge preservation procedure\n* Good general health (ASA I or ASA II)\n* Ability to understand the study procedures and provide written informed consent\n* Willingness to comply with scheduled follow-up visits and study protocol\n\nExclusion Criteria:\n\n* Systemic diseases affecting bone healing (e.g. uncontrolled diabetes, osteoporosis, metabolic bone disorders)\n* History of radiotherapy in the head and neck region\n* Use of bisphosphonates or other antiresorptive medications\n* Active periodontal or periapical infection at the surgical site\n* Heavy smokers (\\>10 cigarettes per day)\n* Pregnancy or breastfeeding\n* Known allergies to materials used in the study\n* Poor oral hygiene or lack of complianc'}, 'identificationModule': {'nctId': 'NCT07272694', 'briefTitle': 'Split Crest Procedure: Is It Necessary to Fill the Gap?', 'organization': {'class': 'OTHER', 'fullName': 'Faculty of Stomatology in Pancevo'}, 'officialTitle': 'A Prospective Controlled Clinical Study Evaluating the Effect of Bone and Autologous Dentin Grafting in the Osteotomy Gap During the Split Crest Procedure With Simultaneous Implant Placement', 'orgStudyIdInfo': {'id': 'SC-DENTIN-2024-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Split Crest Only', 'interventionNames': ['Procedure: Split Crest Technique']}, {'type': 'EXPERIMENTAL', 'label': 'Split Crest + Bone Graft', 'interventionNames': ['Procedure: Split Crest Technique']}, {'type': 'EXPERIMENTAL', 'label': 'Split Crest + Dentin Graft', 'interventionNames': ['Procedure: Split Crest Technique']}], 'interventions': [{'name': 'Split Crest Technique', 'type': 'PROCEDURE', 'description': 'A surgical split crest (alveolar ridge splitting) procedure performed to increase horizontal alveolar bone width and enable simultaneous dental implant placement. A controlled osteotomy is created along the crest of the ridge, followed by gradual expansion of the buccal cortical plate to form an osteotomy gap for implant insertion.', 'armGroupLabels': ['Split Crest + Bone Graft', 'Split Crest + Dentin Graft', 'Split Crest Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26000', 'city': 'Pančevo', 'country': 'Serbia', 'facility': 'Faculty of Stomatology, Department of Oral Surgery, University Business Academy in Novi Sad,', 'geoPoint': {'lat': 44.87177, 'lon': 20.64167}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vladimir Biocanin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Vladimir Biocanin', 'investigatorAffiliation': 'Faculty of Stomatology in Pancevo'}}}}