Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-25 @ 5:34 PM
Study NCT ID:
NCT06054204
Status:
COMPLETED
Last Update Posted:
2023-11-28
First Post:
2023-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrieval of Displaced Root in the Maxillary Sinus Via Lateral Bony Window Using the Piezoelectric Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009957', 'term': 'Oroantral Fistula'}], 'ancestors': [{'id': 'D016155', 'term': 'Oral Fistula'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'single group assignment patients'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-25', 'studyFirstSubmitDate': '2023-09-19', 'studyFirstSubmitQcDate': '2023-09-19', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. degree of pain evaluated clinically', 'timeFrame': 'one-two weeks', 'description': 'using visual analogue scale:0 represent no pain and 10 represents the highest level of pain'}, {'measure': 'soft tissue healing evaluated clinically', 'timeFrame': 'one- two week', 'description': 'presence of dehiscence and exposure of bone or not'}, {'measure': 'the position of bony window evaluated radiographically', 'timeFrame': 'one week', 'description': 'using panoramic view to evaluate the precise position of bony window'}, {'measure': 'bony window osteointegration and density evaluated radiographically', 'timeFrame': 'four months', 'description': 'CT scan will be used using hounsfield units to evaluate density \\>1250 D1 850-1250 D2 350-850 D3 150-350 D4'}], 'secondaryOutcomes': [{'measure': 'inflammation clinically', 'timeFrame': 'one week', 'description': '0 no inflammation 1-3 mild inflammation 4-7 moderate inflammation 8-10 sever inflammation 0 no inflammation 1-3 mild inflammation 4-7 moderate inflammation 8-10 sever inflammation 0 no inflammation 1-3 mild inflammation 4-7 moderate inflammation 8-10 sever inflammation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['displaced root', 'maxillary sinus', 'lateral bony window', 'piezoelectric device'], 'conditions': ['Oroantral Fistula', 'Displaced Tooth']}, 'descriptionModule': {'briefSummary': 'Ten patients with displaced root in maxillary sinus will be included in this study. the root will be recieved via lateral bony window in maxillary sinus wall using peizoelectric device then the bony window will be repositioned in its place.The patients will be received, clinically and radiologically examined, managed and followed up at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University', 'detailedDescription': 'Purpose: This study is designed to allow removal of displaced root from maxillary sinus with minimal surgical injury and simultaneous preservation of the integrity of the lateral wall of maxillary sinus by repositioning of osteotomized lateral bony window.\n\nMaterials \\& Methods: Ten patients with displaced root in maxillary sinus will be included in this study.\n\nsurgical procedure: A full thickness flap will be elevated to expose the lateral wall of the sinus and a rectangular bony window will be done, then the sinus lining will be incised, the displaced root will be delivered, the bony window will be repositioned, and the flap will be sutured.\n\nPreoperative evaluation: The patients will be evaluated clinically for presence of inflammation, infection or oroantral communication and radiographically using computed tomography (CT) scan to identify the position of the displaced root.\n\nPostoperative evaluation: The patients will be evaluated clinically each week for one month regarding to healing, presence of infection, inflammation. Radiographically, immediate panoramic view to evaluate the position of bony window and four months later to evaluate bone healing CT scan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nroot displaced in maxillary sinus absence of infection\n\nExclusion Criteria:\n\n* • patients taking medications that affect bone healing\n* patients underwent head and neck radiotherapy'}, 'identificationModule': {'nctId': 'NCT06054204', 'briefTitle': 'Retrieval of Displaced Root in the Maxillary Sinus Via Lateral Bony Window Using the Piezoelectric Device', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Lecturer of Oral &Maxillofacial Surgery', 'orgStudyIdInfo': {'id': '2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lateral bony window in maxillary sinus', 'description': 'a displaced root in maxillary sinus which will be removed through a rectangular bony window will be done on the lateral wall of sinus using piezo-electric device after elevation of a full thickness mucoperiosteal flap, then the bony window will be repositioned, and the flap will be sutured.', 'interventionNames': ['Device: lateral bony window']}], 'interventions': [{'name': 'lateral bony window', 'type': 'DEVICE', 'description': 'bony window will be made on lateral maxillary sinus wall using piezo-electric device after elevation of full thickness mucoperiosteal membrane', 'armGroupLabels': ['lateral bony window in maxillary sinus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3111', 'city': 'Tanta', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'mona s sheta, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University'}, {'name': 'marwa t Ibrahim, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of oral and maxillofacial surgery department', 'investigatorFullName': 'mona samy sheta', 'investigatorAffiliation': 'Tanta University'}}}}