Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
Study NCT ID:
NCT05604612
Status:
UNKNOWN
Last Update Posted:
2022-11-03
First Post:
2022-10-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of the Effectiveness of Corticision Combined by Selfligating Bracket System on the Acceleration of Orthodontic Tooth Movement; A Prospective Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-30', 'studyFirstSubmitDate': '2022-10-30', 'studyFirstSubmitQcDate': '2022-10-30', 'lastUpdatePostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Little's Irregularity Index", 'timeFrame': 'two months', 'description': 'crowding resolution'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orthodontic Appliance Complication']}, 'descriptionModule': {'briefSummary': 'the goal of this clinical trial is to assess the effectiveness of the corticision with self-ligating bracket system on the acceleration of orthodontic tooth movement.The main question it aims to answer is whether or not there would be an augmented effect by undergoing corticision with using self-ligating brackets regarding the acceleration of orthodontic tooth movement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Class I orthodontic patients with mild to moderate crowding of upper anterior segment (2-4 mm) All permanent teeth are erupted (3rd molar not included). Good oral and general health No systemic disease or regular medication that could interfere and/or affect orthodontic teeth movement No previous orthodontic treatment.\n\nExclusion Criteria:\n\n* Orthodontic cases with severe crowding of upper anterior segment that require extraction treatment approach. Patients with a blocked-out tooth that will not allow for placement of the bracket at the initial bonding appointment. Patients with untreated decay or endodontic lesion.'}, 'identificationModule': {'nctId': 'NCT05604612', 'briefTitle': 'Assessment of the Effectiveness of Corticision Combined by Selfligating Bracket System on the Acceleration of Orthodontic Tooth Movement; A Prospective Clinical Study', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Assessment of the Effectiveness of Corticision Combined by Selfligating Bracket System on the Acceleration of Orthodontic Tooth Movement; A Prospective Clinical Study', 'orgStudyIdInfo': {'id': '721/271'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'interventionNames': ['Procedure: Corticision']}, {'type': 'NO_INTERVENTION', 'label': 'Active Comparator'}], 'interventions': [{'name': 'Corticision', 'type': 'PROCEDURE', 'description': 'Incisions in the cortical plate of maxillary bone', 'armGroupLabels': ['Experimental']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hazem Abd Elhafeez', 'investigatorFullName': 'Hazem Abd Elhafeez Abd Elkhalek', 'investigatorAffiliation': 'Al-Azhar University'}}}}