Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-27 @ 4:46 PM
Study NCT ID:
NCT05610150
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2022-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharyngeal Airway Dimensions With Twinblock Versus Myobrace Appliances in Developing Skeletal Class II 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2022-11-02', 'studyFirstSubmitQcDate': '2022-11-02', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SNA', 'timeFrame': 'Six months', 'description': 'Angle formed between points Sella, Nasion and A point and describes anteroposterior position of the maxilla relative to the anterior cranial base.'}, {'measure': 'SNB', 'timeFrame': 'Six months', 'description': 'Angle formed between points Sella, Nasion and B point and describes anteroposterior position of the mandible relative to the anterior cranial base.'}, {'measure': 'ANB', 'timeFrame': 'Six months', 'description': 'Angle formed between points A, Nasion and B point indicating the skeletal relationship between the maxilla and the mandible.'}, {'measure': 'Witts appraisal', 'timeFrame': 'Six months', 'description': 'The linear distance between the perpendicular projections of points A and B over the functional occlusal plane.'}, {'measure': 'FMA', 'timeFrame': 'Six months', 'description': 'Angle formed between mandibular plane and Frankfort horizontal plane.'}, {'measure': 'Pharyngeal air way area measurement', 'timeFrame': 'Six months', 'description': 'The upper border of Naso Pharyngeal air way area will be delineated by a line extending from the harmonium (H) to the posterior nasal spine. The lower extent of the NPAA will be traced by marking a line at the tip of the soft palate parallel to the Frankfort horizontal (FH) plane extending to the posterior wall of the pharynx. The OPAA and LPAA are differentiated by a line drawn at the level of the tip of epiglottis parallel to the FH plane to the posterior wall of the pharynx. The lower border of the LPAA is defined as a line drawn parallel to FH plane and passing through the anteroinferior most point (C5AI) of the fifth cervical vertebra. Area will be measured.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Airway', 'Myobrace', 'Twinblock'], 'conditions': ['Malocclusion, Angle Class II, Division 1']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the pharyngeal airway changes after treatment with Myobrace and after treatment with Twinblock in developing skeletal Class II patients.\n\nThe main question it aims to answer is: Is the efficacy of the twin-block Vs Myobrace appliances in the improvement of pharyngeal airway dimensions in adolescents having skeletal Class II malocclusion with retrognathic mandible utilizing sagittal pharyngeal airway area measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy children\n* 9-12 Years\n* Skeletal Class II with mandibular defeciency and normal maxillary growth depending on clinical diagnosis and confirmed with lateral cephalometric x-reay readings ( ANB angle \\>4 and SNA angle \\<78)\n\nExclusion Criteria:\n\n* Previous Orthodontic treatment\n* Previous extractions\n* mandibular shifts\n* Severe Crowding\n* Anterior open bite\n* Any perioral habits'}, 'identificationModule': {'nctId': 'NCT05610150', 'briefTitle': 'Pharyngeal Airway Dimensions With Twinblock Versus Myobrace Appliances in Developing Skeletal Class II Patients', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Cephalometric Changes in Pharyngeal Airway Dimensions After Functional Treatment With Twinblock Versus Myobrace Appliances in Developing Skeletal Class II Patients: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '0418-03/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Myobrace functional Appliance', 'description': 'Thirteen patients with developing skeletal Class II malocclusion will be treated with Myobrace functional appliance for six months.', 'interventionNames': ['Device: Myobrace Functional Appliance']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Twin Block Functional appliance', 'description': 'Thirteen patients with developing skeletal Class II malocclusion will be treated with Twinblock functional appliance for six months.', 'interventionNames': ['Device: Twin Block']}], 'interventions': [{'name': 'Myobrace Functional Appliance', 'type': 'DEVICE', 'description': 'An Appliance for treating growing Class II patients with mandibular deficiency', 'armGroupLabels': ['Myobrace functional Appliance']}, {'name': 'Twin Block', 'type': 'DEVICE', 'description': 'An Appliance for treating growing Class II patients with mandibular deficiency', 'armGroupLabels': ['Twin Block Functional appliance']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Ahmed Median', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Ahmed Median, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}