Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
Study NCT ID:
NCT06887595
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-03-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Linear Micro-Perforation Ridge Split Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016301', 'term': 'Alveolar Bone 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2025-03-16', 'studyFirstSubmitQcDate': '2025-03-16', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ridge width', 'timeFrame': '12-months', 'description': 'The width of the alveolar bone will be measured again using CBCT'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alveolar Bone Loss', 'Dental Implant Failed']}, 'descriptionModule': {'briefSummary': 'The traditional ridge split technique might be performed simultaneously with implant placement, resulting in a shortened treatment time. However, this approach has the potential for serious complications, including buccal bone fracture, prolonged pain or paresthesia, and loss of bone height. Linear Micro-Perforation Osteotomy (LMPO) has emerged as a less invasive alternative, promoting natural bone expansion through controlled micro-perforations in the cortical bone, allowing for ridge widening without extensive grafting. However, the precision required for LMPO can be difficult to achieve manually, especially in anatomically complex or narrow ridge areas, leading to variability in outcomes and potential risks such as bone fractures or inadequate expansion.Our study aims to evaluate the efficacy, clinical, and radiological outcomes of the flapless AI-powered/computer-guided LMPO ridge split/expansion technique compared to the traditional LMPO ridge split/expansion method for lateral ridge reconstruction of mandibular horizontal ridge deficiencies.', 'detailedDescription': "In contemporary dentistry, the aim is to replace missing teeth with prosthetics or to remove diseased teeth from the patient and return them to normal in terms of shape, function, comfort, appearance, speech, and health. Why implant dentistry is different is the capacity to fulfill this objective despite atrophy, illness, or harm to the stomatognathic apparatus.\n\nImplant-based dental rehabilitation of partly or completely edentulous areas has become a frequent procedure with consistent long-term outcomes in recent decades. Nevertheless, alveolar ridges are frequently impaired with horizontal inadequacy as a result of bone resorption, which has an impact on implant application.\n\nThe resorption of alveolar bone is a common sequelae of tooth loss and presents a clinical problem for implant placement. Implants must be placed with at least 1 mm of bone on the buccal and lingual aspects to maintain crestal bone levels.\n\nNarrow edentulous ridges less than 5 mm wide present a challenge to the clinician for implant placement. Hence, lateral bone augmentation procedures are necessary to overcome maxillary and mandibular bone deficiencies. These procedures involve the use of bone augmentation, such as guided bone regeneration (GBR), bone block (autogenous or non-autogenous), and conventional onlay/inlay graft. Those procedures have many drawbacks such as longer healing time (6-9 months) for adequate bone regeneration before implant placement, the possibility of membrane exposure, an increased risk of infection, high cost, and rapid graft resorption; thus leading to inadequate bone regeneration or loss of the newly formed bone.\n\nBased on previous knowledge, ridge split/expansion was introduced as an alternative to treat the width insufficiency of alveolar ridges with specific indications. The basic procedure includes a sagittal osteotomy in the center of the edentulous ridge, where the two cortical plates are expanded to increase the width and thereby simultaneous implant insertion with an appropriate diameter could be achieved.\n\nDue to double cellularity and double vascularity gained from the lateral bony plate, bone healing, and regeneration tendency were significantly improved without the need for bone graft or membrane. A shorter treatment period, no need for donor sites, and the possibility of simultaneous implant placement are among the merits of ridge splitting over different augmentation techniques.\n\nFor successful ridge split with simultaneous implantation, the alveolar ridge width should be 3 mm or more with at least 1 mm trabecular bone between the cortical plates.\n\nThe splitting could be performed using the chisel and mallet, the surgical disc, ultra-fine fissure burs, and recently the piezoelectric surgical devices and the electromagnetic mallet. Osteotomes, chisels, bone spreaders, and engine-driven expanders were utilized for Ridge expansion.\n\nThe traditional ridge split technique might be performed simultaneously with implant placement, resulting in a shortened treatment time. However, this approach has the potential for serious complications, including buccal bone fracture, prolonged pain or paresthesia, and loss of bone height. On the other hand, the staged approach has been proposed with splitting and expansion performed followed by implant placement after a 3-week healing interval to allow re-establishment of the blood supply to the surgical site.\n\nLinear Micro-Perforation Osteotomy (LMPO) has emerged as a less invasive alternative, promoting natural bone expansion through controlled micro-perforations in the cortical bone, allowing for ridge widening without extensive grafting. However, the precision required for LMPO can be difficult to achieve manually, especially in anatomically complex or narrow ridge areas, leading to variability in outcomes and potential risks such as bone fractures or inadequate expansion.\n\nComputer-guided technology presents an opportunity to enhance LMPO by providing a structured, pre-planned guide for split-osteotomy and expansion. Utilizing 3D imaging data, a computer-guided splint can be custom-fabricated to fit each patient's unique anatomy, offering unparalleled accuracy in osteotomy execution and minimizing the risk of error. Additionally, performing LMPO without flap elevation with the assistance of this guided splint further reduces surgical trauma, preserves periosteal blood supply, and promotes faster healing, making it a more patient-friendly option.\n\nLimited clinical data are available about LMPO. Our study aims to evaluate the efficacy, clinical, and radiological outcomes of the flapless AI-powered/computer-guided LMPO ridge split/expansion technique compared to the traditional LMPO ridge split/expansion method for lateral ridge reconstruction of mandibular horizontal ridge deficiencies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presenting with narrow alveolar ridge that requires dental implantation.\n\n * Minimum bone width of 3 mm\n * Ridge width of not less than 3 mm in CBCT image\n * Minimum bone height of 10 mm\n * Proper inter-occlusal space\n * Perioperative cone beam CT scan image of the atrophic ridge\n\nExclusion Criteria:\n\n* • Uncontrolled diabetes.\n\n * Heavy smokers.\n * Current chemotherapy or radiotherapy.\n * Alcohol or drug abuse.\n * Pregnant women.\n * Active infection.\n * Inter-occlusal space not less than 7-8 mm.'}, 'identificationModule': {'nctId': 'NCT06887595', 'briefTitle': 'Linear Micro-Perforation Ridge Split Approach', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'A Comparative Study of AI-Powered/Computer-Guided Versus Conventional Linear Micro-Perforation Split Approach for Treatment of Horizontal Mandibular Ridge Atrophy (A Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': 'KFSIRB200-467'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group I', 'description': 'ridge split and expansion with free-hand linear micro perforation osteotomy approach with simultaneous implant placement', 'interventionNames': ['Procedure: Free-hand linear micro perforation osteotomy and ridge splitting']}, {'type': 'EXPERIMENTAL', 'label': 'study group II', 'description': 'ridge split and expansion with AI-assisted/computer-guided (linear micro perforation osteotomy approach with simultaneous implant placement)', 'interventionNames': ['Procedure: AI-assisted/computer-guided linear micro perforation osteotomy and ridge splitting']}], 'interventions': [{'name': 'Free-hand linear micro perforation osteotomy and ridge splitting', 'type': 'PROCEDURE', 'otherNames': ['Free-hand crestal ridge splitting expansion after linear micro perforation osteotomy will be performed using electromagnetic mallet'], 'description': 'AI-assisted/computer-guided linear micro perforation osteotomy and ridge splitting', 'armGroupLabels': ['study group I']}, {'name': 'AI-assisted/computer-guided linear micro perforation osteotomy and ridge splitting', 'type': 'PROCEDURE', 'description': 'AI-assisted/computer-guided crestal ridge splitting expansion after linear micro perforation osteotomy will be performed using electromagnetic mallet', 'armGroupLabels': ['study group II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '214312', 'city': 'Kafr ash Shaykh', 'state': 'Kafrelsheikh', 'country': 'Egypt', 'facility': 'faculty of dentistry, kafrelsheikh University', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of periodontology', 'investigatorFullName': 'Walid Elamrousy', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}