Ignite Creation Date:
2025-12-24 @ 1:27 PM
Ignite Modification Date:
2025-12-28 @ 6:14 AM
Study NCT ID:
NCT04720495
Status:
COMPLETED
Last Update Posted:
2021-01-22
First Post:
2021-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
One-stage Versus Two-stage Inverted U-shaped Ridge Splitting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-19', 'studyFirstSubmitDate': '2021-01-19', 'studyFirstSubmitQcDate': '2021-01-19', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in bone density buccal to the implant', 'timeFrame': 'baseline and 4 months', 'description': 'Bone density was evaluated by CBCT'}, {'measure': 'Change in bone width gain at the undercut area', 'timeFrame': 'baseline and 4 months', 'description': 'Bone width gain was evaluated by CBCT'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Maxillary Ridge Augmentation']}, 'descriptionModule': {'briefSummary': 'Fourteen patients having anterior maxillary undercut defect were selected to match a list of inclusion and exclusion criteria.\n\nThe participants were randomly allocated using a computer system into two groups:\n\nGroup A undergo inverted U-shaped maxillary ridge splitting using piezotomes with simultaneous implant placement in the same surgery.\n\nGroup B undergo inverted U-shaped maxillary ridge splitting as a first stage and after four weeks, ridge expansion and implant placement will be performed with only envelop flap.\n\nAssessment included measurements of bone gain at the undercut defect and bone density labial to implants in each group from the cone-beam computed tomography'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Adult patients (20-45) years of age with no sex predilection\n* At least one tooth missing in the anterior maxilla\n* The presence of a labial undercut \\>2 mm in thickness which is not able to house an implant\n* The presence of adequate bone width near the alveolar bone crest\n* The absence of a vertical bone defect.\n\nExclusion criteria\n\n* History of any systemic disease that would contraindicate surgery example uncontrolled diabetes.\n* Pregnancy or lactation.\n* Long-term amino-bisphosphonate therapy.\n* Smoking more than 10 cigarettes per day.\n* Alcohol or drug abuse.\n* Uncontrolled periodontal disease.\n* Active infection.\n* Inadequate inter-incisal space.\n* Bruxism or clenching.'}, 'identificationModule': {'nctId': 'NCT04720495', 'briefTitle': 'One-stage Versus Two-stage Inverted U-shaped Ridge Splitting', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'One-stage Versus Two-stage Inverted U-shaped Ridge Splitting With Simultaneous Implant Placement for Treatment of Anterior Maxillary Alveolar Ridge Undercut (a Comparative Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': 'Ridge_splitting'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'One stage ridge splitting', 'interventionNames': ['Procedure: One stage ridge splitting with simultaneous implant placement']}, {'type': 'EXPERIMENTAL', 'label': 'Two-stage ridge splitting', 'interventionNames': ['Procedure: Two-stage ridge splitting with implant placement']}], 'interventions': [{'name': 'One stage ridge splitting with simultaneous implant placement', 'type': 'PROCEDURE', 'description': 'A full mucoperiosteal flap was raised using the sharp periosteal elevator to expose the bone crestally and buccally.\n\nAn inverted U-shaped bone cut, down to the cancellous bone, was done in the undercut area with a piezoelectric device.\n\nThe horizontal bone cut was made apical to the most concave point in the undercut area with a distance of 3 mm.\n\nThe two vertical bone cuts were placed at least 1 mm away from the adjacent roots and extended beyond the undercut area.\n\nThe released bone end was minimally elevated using a periosteotome through a greenstick fracture.\n\nAll implants were installed with the implant shoulders flush to the bone level using a low-speed drilling procedure.', 'armGroupLabels': ['One stage ridge splitting']}, {'name': 'Two-stage ridge splitting with implant placement', 'type': 'PROCEDURE', 'description': 'The first surgery is the same as one stage ridge splitting Four weeks later, after revascularization between the bone block and the mucoperiosteum, the second surgery will be performed.\n\nA crestal incision was done and the envelope flap slightly elevated to preserve the blood supply.\n\nThe implants will be placed in the same manner as one stage ridge splitting', 'armGroupLabels': ['Two-stage ridge splitting']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hams Hamed Abdelrahman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of DPH and Clinical statistician', 'investigatorFullName': 'Hams Hamed Abdelrahman', 'investigatorAffiliation': 'Alexandria University'}}}}