Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 2:42 AM
Study NCT ID:
NCT07467369
Status:
COMPLETED
Last Update Posted:
2026-03-12
First Post:
2026-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Mallet and Piezotome in Atrophic Anterior Maxillary Ridge Expansion With Simultaneous Bone Graft and Implant Placement (
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-03-09', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'secondary implant stability', 'timeFrame': 'up to 6 months', 'description': '(2ry stability ) will be recorded after 6 months by using osstell device. The result is presented in form of ISQ value from 1to 100, the higher the ISQ the higher the stability of implant.'}], 'secondaryOutcomes': [{'measure': 'change in pain scores', 'timeFrame': 'up to 7 days', 'description': 'Pain will be assessed for 7 days postoperatively using 10-point visual analouge scale (VAS)(0-1=None, 2-4=mild, 5-7=moderate, 8-10=severe )'}, {'measure': 'change in labial bone thickness', 'timeFrame': 'baseline and 6 months', 'description': 'it will be measured on CBCT'}, {'measure': 'Marginal bone loss', 'timeFrame': 'up to 6 months', 'description': 'it will be measured on CBCT'}, {'measure': 'change in bone density', 'timeFrame': 'up to 6 months', 'description': 'it will be measured on CBCT'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alveolar Bone Loss']}, 'descriptionModule': {'briefSummary': 'Background: teeth loss in the anterior maxilla initiate residual ridge resorption, especially in the anterior region. The consequence of this resorption is a gradual medial or palatal shift of the crest of maxilla. This results in change in facial morphology as result of diminished maxillary lip support. This may also lead to compromised occlusal relationship of prosthetic teeth as they are positioned labially to the crest of alveolar ridge.\n\nAim: to compare the use of magnetic mallet and piezotome in atrophic anterior maxillary ridge expansion with simultaneous bone graft and implant placement.Materials and Methods: 20 patients with anterior atrophic maxilla will be included in the study. Patients will be divided into two groups, group A the bone expansion will be done by the magnetic mallet. Group B the bone expansion will be done by the piezotome , both groups will have bone graft and implant.\n\nclinical evaluation will include intra operative and post operative evaluation, primary and secondary stability, operative time and time . Radiographic evaluation will include bone density and marginal bone loss around the tnalpmi'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* alveolar ridge width from 3-5 mm\n* Patient with missing more than two anterior maxillary teeth\n* Patient with good oral hygiene and acceptable inter-arch space\\[8-12mm\\] for the restoration\n* D3 bone density\n\nExclusion Criteria:\n\n* Heavy smoker, alcohol abuse, parafunctional habits.\n* Patient with uncontrolled hypertension, uncontrolled diabetes, on radiation therapy'}, 'identificationModule': {'nctId': 'NCT07467369', 'briefTitle': 'Magnetic Mallet and Piezotome in Atrophic Anterior Maxillary Ridge Expansion With Simultaneous Bone Graft and Implant Placement (', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Comparison Between Magnetic Mallet and Piezotome in Atrophic Anterior Maxillary Ridge Expansion With Simultaneous Bone Graft and Implant Placement (Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': '0915-05/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'interventionNames': ['Procedure: ridge expansion by piezotome']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'interventionNames': ['Procedure: ridge expansion by magnetic mallet']}], 'interventions': [{'name': 'ridge expansion by magnetic mallet', 'type': 'PROCEDURE', 'description': 'Surgery will be performed under local anesthesia using articaine with 1:100,000 adrenaline, a full-thickness buccal and palatal flaps will be raised. After the flaps were reflected, the crestal incision will be performed into the bone to perform an intra-osseous groove with an n. 64 beaver blade attached to magnetic mallet, this groove will be continued apically down to 7-11mm. The implant site will be created by expanding the bone tissue both laterally against the preexisting walls and apically by using osteotome attached to magnetic mallet, in this way the buccal plate will be slowly dislocated in a facial direction.', 'armGroupLabels': ['Control Group']}, {'name': 'ridge expansion by piezotome', 'type': 'PROCEDURE', 'description': 'Surgery will be performed under local anesthesia using articaine with 1:100,000 adrenaline, after exposing the ridge, a sagittal osteotomy of 1mm depth will be outlined in the cortical bone by using sharp piezoelectric insert no. OT2. After that the sagittal osteotomic cut will be deepened with a 0.25 mm diameter piezoelectric micro-saw no. OT12s toward apical direction, at depth equivalent to the planned implant length. When the bone cuts will be completed, the ridges will be separated in buccal/lingual direction using densah burs . Then implants will be placed within the confines of the newly created space .', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Alexandria Faculty of Dentistry', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}