Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-02-28 @ 4:57 AM
Study NCT ID:
NCT06500559
Status:
COMPLETED
Last Update Posted:
2025-09-10
First Post:
2024-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alveolar Bone Dehiscence and Fenestration Following Accelerated Maxillary Canine Retraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2024-07-08', 'studyFirstSubmitQcDate': '2024-07-08', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alveolar bone dehiscence', 'timeFrame': '4 months', 'description': 'Pre- and post- retraction CBCTs will be obtained from patients. Linear measurement (mm) for dehiscence (LM-D) will be defined as the distance between the alveolar crest to the cementoenamel junction of each root (critical point will be set at 2 mm)'}, {'measure': 'Alveolar bone fenestration', 'timeFrame': '4 months', 'description': 'Pre- and post- retraction CBCTs will be obtained from patients. Linear measurement (mm) for fenestration (LM-F) will be recorded when the defect involved only the apical one-third of a root (critical point will be set at 2.2 mm)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['accelerated orthodontics', 'Dehiscence', 'fenestration', 'CBCT'], 'conditions': ['Fenestration', 'Dehiscence']}, 'descriptionModule': {'briefSummary': 'Alveolar bone loss and fenestration are the most prevalent bone defects that often result in root exposure, gingival recession, and potential treatment relapse or failure. These issues present complications in orthodontic therapy. Hence, reducing the length of orthodontic therapy and minimizing the occurrence of these serious complications are highly important for orthodontic patients, particularly adults. platelet-rich plasma (PRP) injection and decortication are two promising methods for accelerated tooth movements. Thus, The aim of this study is to evaluate alveolar bone dehiscence and fenestrations after canine retraction, using alveolar decortication and PRP injection as two methods for accelerating tooth movements.'}, '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': 'NCT06500559', 'briefTitle': 'Alveolar Bone Dehiscence and Fenestration Following Accelerated Maxillary Canine Retraction', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Comparison of Alveolar Bone Dehiscence and Fenestration Following Maxillary Canine Retraction Using Two Methods of Tooth Movement Acceleration. A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '#R-ORTH-6-24-3117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group I: PRP injection', 'description': 'Accelerated maxillary canine retraction will be done after PRP injection in one random side of the maxillary arch while the other side serve as control', 'interventionNames': ['Procedure: PRP injection']}, {'type': 'EXPERIMENTAL', 'label': 'group II: Combined decortication and PRP injection', 'description': 'Accelerated maxillary canine retraction will be done after combined decortication and PRP injection in one random side of the maxillary arch while the other side serve as control', 'interventionNames': ['Procedure: Combined decortication and PRP injection']}], 'interventions': [{'name': 'PRP injection', 'type': 'PROCEDURE', 'description': 'PRP (0.7 ml = 70 unit) will be injected submucosal disto-buccal and disto-palatal to the maxillary canine like the local anesthesia injection in group I experimental sides', 'armGroupLabels': ['group I: PRP injection']}, {'name': 'Combined decortication and PRP injection', 'type': 'PROCEDURE', 'description': 'Experimental sides will receive PRP injection 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': ['group II: Combined decortication and PRP injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6624033', 'city': 'Tanta', 'state': 'Tanta', 'country': 'Egypt', 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Orthodontics', 'investigatorFullName': 'Safa Basiouny Alawy', 'investigatorAffiliation': 'Tanta University'}}}}