Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-03-01 @ 1:44 PM
Study NCT ID:
NCT06602518
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in the Sagittal Pharyngeal Airway Dimension Following Leveling and Alignement in Class II Division 2 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008312', 'term': 'Malocclusion, Angle Class II'}], 'ancestors': [{'id': 'D008310', 'term': 'Malocclusion'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009970', 'term': 'Orthodontics'}], 'ancestors': [{'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 27}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-15', 'studyFirstSubmitDate': '2024-09-15', 'studyFirstSubmitQcDate': '2024-09-15', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the sagittal pharyngeal airway space (SPAD)', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Changes in the mandibular position', 'timeFrame': '6 months'}, {'measure': 'Sagittal skeletal measurements', 'timeFrame': '6 months'}, {'measure': 'Vertical skeletal measurements', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Class II Division 2 Malocclusion']}, 'descriptionModule': {'briefSummary': 'Aim of the study: is to compare the changes in the sagittal pharyngeal airway dimension (SPAD) and mandibular position before and after the levelling and alignment stage of orthodontic treatment in Class II division 2 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Class II/2 subjects as per the British Standard Institute Classification.\n* Age ranging from 12-16 years, with Cervical Vertebral Maturational Index (CVMI) stages 4, and 5.\n* Contact between maxillary and mandibular incisors, with the presence of a deep bite of at least 70%.\n* Full permanent dentition, aside from the third molars\n\nExclusion Criteria:\n\n* Previous orthodontic treatment.\n* Patients with severe transverse problems, pain and/or clicking sound in the temporomandibular joint (TMJ).\n* Patients with craniofacial anomalies or diagnosed syndromes'}, 'identificationModule': {'nctId': 'NCT06602518', 'briefTitle': 'Changes in the Sagittal Pharyngeal Airway Dimension Following Leveling and Alignement in Class II Division 2 Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Alexandria'}, 'officialTitle': 'Changes in the Sagittal Pharyngeal Airway Dimension Following Leveling and Alignement in Class II Division 2 Patients: A Prospective Clinical Trial', 'orgStudyIdInfo': {'id': '1/6-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Levelling and alignment', 'interventionNames': ['Procedure: Orthodontic Treatment']}], 'interventions': [{'name': 'Orthodontic Treatment', 'type': 'PROCEDURE', 'description': 'All the enrolled patients will undergo conventional fixed appliance therapy by bonding straight wire Roth appliance in the maxillary arch. The bonding procedure will be standardized in all patients and performed by the same operator using light-cured composite. Levelling and alignment will then be started using the following wire sequence: 0.014-in nickel titanium (NiTi), 0.018-in NiTi, 17×25-in Niti, and 19×25-in Niti arch wires. The upper arch will then be stabilized using a 19×25-in stainless steel (SS) arch wire for 2 months. This stage will require approximately 6 months of treatment.', 'armGroupLabels': ['Levelling and alignment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Farah Y Eid, PhD', 'role': 'CONTACT', 'email': 'farahyousry66@gmail.com', 'phone': '+20 10 01495565'}], 'facility': 'Faculty of Dentistry, Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'Farah Y Eid, PhD', 'role': 'CONTACT', 'email': 'farahyousry66@gmail.com', 'phone': '+201001495565'}], 'overallOfficials': [{'name': 'Farah Y Eid, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry, Alexandria University, Egypt'}, {'name': 'Dina Elfouly, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Dentistry, Alexandria University, Egypt'}, {'name': 'Ahmed Madian, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Dentistry, Alexandria University, Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nourhan M.Aly', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Dental Public Health', 'investigatorFullName': 'Nourhan M.Aly', 'investigatorAffiliation': 'University of Alexandria'}}}}