Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:13 PM
Study NCT ID:
NCT06975358
Status:
RECRUITING
Last Update Posted:
2025-06-27
First Post:
2025-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Accelerated Orthodontics With Alveolar Decortication Plus CGF Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000054', 'term': 'Acceleration'}], 'ancestors': [{'id': 'D009038', 'term': 'Motion'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2025-05-08', 'studyFirstSubmitQcDate': '2025-05-08', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of canine retraction', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Accelerate Tooth Movement']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to evaluate alveolar bone decortication combined with CGF Injection on tooth movement acceleration'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '22 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age of the patients ranged from 16: 22 years old.\n2. Malocclusion that requires extraction of the maxillary first premolar and canine retraction (e.g. class I bimaxillary dentoalveolar protrusion and class II div 1 malocclusion).\n3. Maximum anchorage needed for the maxillary arch as a part of the orthodontic treatment plan.\n4. Good oral hygiene and periodontal condition.\n\nExclusion Criteria:\n\n1. Medically compromised patients.\n2. Severe crowding in the maxillary arch.\n3. Chronic intake of NSAIDs or any medication that interfere with OTM.\n4. Previous orthodontic treatment.'}, 'identificationModule': {'nctId': 'NCT06975358', 'briefTitle': 'Accelerated Orthodontics With Alveolar Decortication Plus CGF Injection', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Impact of Alveolar Decortication Combined With CGF Injection on Acceleration of Maxillary Canine Retraction-A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '#R-OS-12-24-3158'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alveolar decortication plus CGF', 'description': 'Alveolar decortication followed by submucosal CGF injection (70 units) disto-buccal and disto-palatal to the maxillary canine will be randomly assigned to one side of the maxillary arch (experimental) while the other side serve as (control) receiving orthodontic treatment without any additional intervention', 'interventionNames': ['Procedure: Alveolar decortication plus CGF injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'the other side of the maxillary arch will receive the usual orthodontic treatment without any additional intervention', 'interventionNames': ['Procedure: canine retraction without acceleration']}], 'interventions': [{'name': 'Alveolar decortication plus CGF injection', 'type': 'PROCEDURE', 'description': 'Experimental sides will receive CGF injection (70 units) disto-buccal and disto-palatal to the maxillary canine after performing decortication. After administration of local anesthesia, two-line flap will be performed from the mesial surface of the maxillary second premolar to the distal surface of the maxillary canine Mucoperiosteal flap will be reflected in the buccal side. Two millimeters of marginal crestal bone will be held intact and using a high-speed drill and a round carbide bur (1mm diameter) under copious saline irrigation, the cortical wall will be penetrated to reach marrow spaces. Multiple perforations (10 holes for standardization) in the cortical bone will be created. The surgical site will then rinsed, and the flap will be repositioned and sutured.', 'armGroupLabels': ['Alveolar decortication plus CGF']}, {'name': 'canine retraction without acceleration', 'type': 'PROCEDURE', 'description': 'in the control side, the maxillary canine will be retracted without any acceleration procedure', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6624033', 'city': 'Tanta', 'state': 'Tanta', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Safa B Alawy, PhD', 'role': 'CONTACT', 'email': 'safa_basyouny@dent.tanta.edu.eg', 'phone': '+201009088252'}], 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Safa B Alawy, PhD', 'role': 'CONTACT', 'email': 'safa_basyouny@dent.tanta.edu.eg', 'phone': '0201009088252'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Safa Basiouny Alawy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Orthodontics', 'investigatorFullName': 'Safa Basiouny Alawy', 'investigatorAffiliation': 'Tanta University'}}}}