Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-01-01 @ 10:46 PM
Study NCT ID:
NCT06452368
Status:
COMPLETED
Last Update Posted:
2024-06-14
First Post:
2024-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Palatal Versus Buccal Protraction Using Plates Assisted With Facemask in Growing Class III Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008313', 'term': 'Malocclusion, Angle Class III'}], 'ancestors': [{'id': 'D008310', 'term': 'Malocclusion'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-12', 'studyFirstSubmitDate': '2024-06-05', 'studyFirstSubmitQcDate': '2024-06-05', 'lastUpdatePostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cephalometric radiographs', 'timeFrame': '12 month', 'description': 'cephalometric radiographs were analyzed and the amount of maxillary protraction, the dentoskeletal as well the soft tissue changes were evaluated'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Class III Malocclusion']}, 'descriptionModule': {'briefSummary': 'to compare Palatal and buccal protraction using plates assisted with facemask in growing class III patients', 'detailedDescription': 'A randomized controlled clinical trial was adopted in this study. A total of 20 growing Class III patients were selected from patients seeking orthodontic treatment. The participants were recruited from the department of Orthodontics at Faculty of Dentistry, Mansoura University. No active advertisement was used for participant recruitment, and instead, a convenience sample was formed. Prior to participating in the study, the purpose of the study was explained to the parents of the children and informed consents and assents were obtained according to the guidelines on human research adopted by the Research Ethics Committee Faculty of Dentistry, Mansoura University'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Growing patients with age ranged between 8-13 years old.\n* Patients should have examination: Class III malocclusion due to maxillary retrusion as verified by clinical and radiographic examination; SNA \\<79 and ANB angle \\< -1.\n* Good likelihood of recall availability.\n\nExclusion Criteria:\n\n* Vertical skeletal mal relationship.\n* History of previous orthodontic/orthopedic treatment.\n* Bad habits that may jeopardize the appliance.\n* Patients with systemic diseases\n* Congenital deformities such as cleft lip and/or palate.'}, 'identificationModule': {'nctId': 'NCT06452368', 'briefTitle': 'Palatal Versus Buccal Protraction Using Plates Assisted With Facemask in Growing Class III Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Palatal Versus Buccal Protraction Using Plates Assisted With Facemask in Growing Class III Patients', 'orgStudyIdInfo': {'id': 'M04020822'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Palatal protraction', 'description': 'Palatal plate assisted with facemask', 'interventionNames': ['Device: facemask']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Buccal protraction', 'description': 'Buccal plate assisted with facemask', 'interventionNames': ['Device: facemask']}], 'interventions': [{'name': 'facemask', 'type': 'DEVICE', 'description': 'Fixation of miniplates by four screws in the maxilla and protraction by using facemask', 'armGroupLabels': ['Buccal protraction', 'Palatal protraction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Mohamed Adel Raghib', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Phd researcher', 'investigatorFullName': 'Mohamed Adel Raghib', 'investigatorAffiliation': 'Mansoura University'}}}}