Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 11:32 PM
Study NCT ID:
NCT07066293
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-04
First Post:
2025-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sticky Bone Grafting With Concentrated Growth Factor Membrane for Repair of Unilateral Alveolar Cleft
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2025-07-04', 'studyFirstSubmitQcDate': '2025-07-04', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'inflammation', 'timeFrame': '1 month', 'description': 'mild, moderate, severe'}, {'measure': 'nasal regurgitation', 'timeFrame': '1 month', 'description': 'Yes or No'}, {'measure': 'fistula recurrence', 'timeFrame': '1 month', 'description': 'positive or negative'}, {'measure': 'bone graft volume', 'timeFrame': '1 month', 'description': 'soft ware'}, {'measure': 'bone mineral density', 'timeFrame': '1 month', 'description': 'soft ware'}], 'secondaryOutcomes': [{'measure': 'bone graft volume', 'timeFrame': '9 months', 'description': 'soft ware'}, {'measure': 'bone mineral density', 'timeFrame': '9 months', 'description': 'soft ware'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['alveolar cleft', 'sticky bone', 'concentrated growth factor', 'volumetric assessment', 'bone mineral density'], 'conditions': ['Unilateral Alveolar Cleft of Maxilla']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate using Sticky Bone grafting combined with concentrated growth factor membrane for repair of unilateral alveolar cleft.', 'detailedDescription': 'This study will be carried out on ten patients with unilateral alveolar clefts, The patients will be recieved, clinically\\& radiographically examined and managed at Oral \\& Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University.\n\nPreoperative evaluation:\n\nClinical evaluation will include presence of oronasal fistulas, nasal regurgitation and Presence of erupting teeth in cleft. .Preoperative cone beam computed tomography (CBCT) scans will be analyzed to measure alveolar cleft dimensions and the total cleft defect volume will be calculated.\n\nSurgical technique:\n\nUnder general anesthesia, mucoperiosteal flaps will be raised along the cleft margins, exposing the defect. The nasal lining will be sutured with 4/0 Vicryl, followed by the application of a concentrated growth factor (CGF) membrane to cover the nasal mucosa. The sticky bone graft will be packed tightly into the cleft, ensuring complete defect filling. A CGF membrane will be then placed over the graft to enhance stability and healing. The flaps will be sutured using tension-free interrupted 3/0 Vicryl sutures to ensure full coverage of the graft.\n\nPostoperative evaluation:\n\nThe patients will be evaluated over a nine-months follow-up period clinically at intervals of 1st \\& 2nd weeks, then 1st ,3rd and 9th months for healing parameters such as infection, wound dehiscence, recurrence of oronasal fistulas, nasal regurgitation and graft exposure \\& radiographically by using CBCT for assessing graft volume, bone mineral density immediate, 3rd \\& 9th months postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with unilateral alveolar clefts requiring repair.\n* patients free from any systemic disease that may affect normal healing of bone.\n* patients at an age older than 12 years\n\nExclusion Criteria:\n\n* Bilateral alveolar clefts.\n* Immunocompromised patients.\n* Syndromic patients.'}, 'identificationModule': {'nctId': 'NCT07066293', 'briefTitle': 'Sticky Bone Grafting With Concentrated Growth Factor Membrane for Repair of Unilateral Alveolar Cleft', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Evaluation of Using Sticky Bone Grafting Combined With Concentrated Growth Factor Membrane for Repair of Unilateral Alveolar Cleft', 'orgStudyIdInfo': {'id': '#R-OS-11-22-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sticky Bone grafting with concentrated growth factor membrane for unilateral alveolar cleft', 'description': 'This will include 10 patients in whom unilateral alveolar cleft will be repaired using sticky bone grafting combined with concentrated growth factor membrane', 'interventionNames': ['Procedure: Unilateral alveolar cleft repair']}], 'interventions': [{'name': 'Unilateral alveolar cleft repair', 'type': 'PROCEDURE', 'description': '10 patients in whom unilateral alveolar cleft will be repaired using sticky bone grafting combined with concentrated growth factor membrane', 'armGroupLabels': ['Sticky Bone grafting with concentrated growth factor membrane for unilateral alveolar cleft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'Omnia M Saber', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry, Tanta University, Egypt'}, {'name': 'Mohamed S Khedr, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry, Tanta University, Egypt'}, {'name': 'Ahmed M Elshareef, Ass prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry, Tanta University, Egypt'}, {'name': 'Maram N Breshah, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry, Tanta University, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Oral & Maxillofacial Surgery', 'investigatorFullName': 'Maram Nashaat Breshah', 'investigatorAffiliation': 'Tanta University'}}}}