Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT05173402
Status:
COMPLETED
Last Update Posted:
2021-12-29
First Post:
2021-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treating Gnathic Form of Mesial Occlusion in Early Adolescence Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008397', 'term': 'Masks'}], 'ancestors': [{'id': 'D058257', 'term': 'Surgical Attire'}, {'id': 'D004865', 'term': 'Equipment and Supplies, Hospital'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D011482', 'term': 'Protective Devices'}, {'id': 'D000067393', 'term': 'Personal Protective Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-23', 'studyFirstSubmitDate': '2021-12-14', 'studyFirstSubmitQcDate': '2021-12-23', 'lastUpdatePostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'dentoalveolar compensation method', 'timeFrame': '2014-2020', 'description': 'orthopedic treatment was performed using the dentoalveolar compensation method with permanent apparatus with a palatal expanding screw'}, {'measure': 'face mask', 'timeFrame': '2014-2020', 'description': 'orthopedic treatment was performed using a face mask'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['early adolescence', 'orthodontic practice', 'orthodontic treatment'], 'conditions': ['Gnathic (Skeletal) Mesial Occlusion']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study was to evaluate the immediate and previous results of the effectiveness of non-surgical orthopedic treatment in children aged 12-14 years with gnathic forms of mesial occlusion by the method of dentoalveolar compensation using a permanent apparatus with a palatal expanding screw.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'To evaluate the early and late results of the non-surgical orthopedic treatment efficiency in 12-14 years old children with the gnathic forms of mesial occlusion by the dentoalveolar compensation utilizing a permanent device with a palatal expanding screw.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\npatients with a gnathic (skeletal) mesial occlusion patients age 12-14 years patients who underwent orthopedic treatment\n\nExclusion Criteria:\n\nchange of residence severe form of gnathic mesial occlusion congenital anomalies of the dento-maxillo-facial area'}, 'identificationModule': {'nctId': 'NCT05173402', 'briefTitle': 'Treating Gnathic Form of Mesial Occlusion in Early Adolescence Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'The 108 Military Central Hospital'}, 'officialTitle': 'Treating Gnathic Form of Mesial Occlusion in Early Adolescence Patients: A Clinical Trial', 'orgStudyIdInfo': {'id': 'Le Thi Thu Hai'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The experimental group', 'description': 'The experimental group included 26 patients - orthopedic treatment was performed using the dentoalveolar compensation method with permanent apparatus with a palatal expanding screw.', 'interventionNames': ['Device: dentoalveolar compensation method']}, {'label': 'The comparison group', 'description': 'The comparison group included 20 patients - orthopedic treatment was performed using a face mask.', 'interventionNames': ['Device: face mask']}], 'interventions': [{'name': 'dentoalveolar compensation method', 'type': 'DEVICE', 'description': 'orthopedic treatment was performed using the dentoalveolar compensation method with permanent apparatus with a palatal expanding screw', 'armGroupLabels': ['The experimental group']}, {'name': 'face mask', 'type': 'DEVICE', 'description': 'orthopedic treatment was performed using a face mask.', 'armGroupLabels': ['The comparison group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The study was anonymous. No personal data will be revealed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The 108 Military Central Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr., Associate Professor', 'investigatorFullName': 'Le Thi Thu Hai', 'investigatorAffiliation': 'The 108 Military Central Hospital'}}}}