Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-01-01 @ 5:20 PM
Study NCT ID:
NCT05433051
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2022-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Two Protocol for Maxillary Molar Intrusion Buccal Miniscrew and TPA Versus Vertical Holding Appliance
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': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-21', 'studyFirstSubmitDate': '2022-06-22', 'studyFirstSubmitQcDate': '2022-06-22', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'amount of dental', 'timeFrame': 'Post-intervention at 6 months', 'description': 'rate of maxillary molar intrusion by cephalometry'}, {'measure': 'amount of skeletal changes', 'timeFrame': 'Post-intervention at 6 months', 'description': 'amount of vertical overlap by cephalometry'}, {'measure': 'amount of skeletal changes', 'timeFrame': 'Post-intervention at 6 months', 'description': 'amount of mandibular rotation by cephalometry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TPA', 'Miniscrew', 'intrusion', 'vertical holding appliance', 'cephalometry'], 'conditions': ['Dental Intrusion', 'Mandibular Rotation', 'ANB , SNA, SNB', 'Openbite Teeth | Teeth and Gum | Dental']}, 'descriptionModule': {'briefSummary': 'this study is to compare the dental and skeletal changes caused by the intrusion of maxillary first molars buccal miniscrew and TPA versus vertical holding appliance using lateral cephalometry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering class I or II with AOB.\n* AOB ranged between 3-7 mm assessed from cephalometry.\n* Patients with excess in posterior dentoalveolar height according to Burrstone .\n* Patients with good oral hygiene and general health.\n* Patients with no previous orthodontic treatment.\n* Good quality of lateral cephalometry.\n\nExclusion Criteria:\n\n* Skeletal open bite\n* previous orthodontic treatment'}, 'identificationModule': {'nctId': 'NCT05433051', 'briefTitle': 'A Comparison of Two Protocol for Maxillary Molar Intrusion Buccal Miniscrew and TPA Versus Vertical Holding Appliance', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'A Comparison of Two Protocol for Maxillary Molar Intrusion Buccal Miniscrew and TPA Versus Vertical Holding Appliance Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '807/220'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Buccal miniscrews with TPA', 'description': 'active comparator double center', 'interventionNames': ['Biological: buccal miniscrew and TPA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'vertical holding appliance', 'description': 'active comparator double center', 'interventionNames': ['Biological: vertical holding appliance']}], 'interventions': [{'name': 'buccal miniscrew and TPA', 'type': 'BIOLOGICAL', 'description': 'intrusion of molars', 'armGroupLabels': ['Buccal miniscrews with TPA']}, {'name': 'vertical holding appliance', 'type': 'BIOLOGICAL', 'description': 'intrusion of molars', 'armGroupLabels': ['vertical holding appliance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Cairo', 'state': 'Nasr City', 'country': 'Egypt', 'facility': 'Mohamed Shendy', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'Mohamed Abdelrhman Shendy Abdelrhman', 'investigatorAffiliation': 'Al-Azhar University'}}}}