Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2026-01-02 @ 10:08 AM
Study NCT ID:
NCT07127328
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-17
First Post:
2025-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Benefits of an Orthodontic Device Removable Functional Appliance in the Management of Malocclusions/Orofacial Dysfunctions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009970', 'term': 'Orthodontics'}], 'ancestors': [{'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2025-08-11', 'studyFirstSubmitQcDate': '2025-08-11', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvment of malocclusion dysfunctions with removable functional appliances', 'timeFrame': 'A follow-up every 6 weeks for 6 months.', 'description': 'The improvment of malocclusion is evaluated with the observation of photography and videos with cephalometric analyze (Steiner).'}, {'measure': 'Correction of dysfunctions with removable functional appliances', 'timeFrame': 'A follow-up every 6 weeks for 6 months.', 'description': 'The correction is evaluated with the observation of photography and videos with cephalometric analyze (Steiner).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orthodontic Appliances']}, 'descriptionModule': {'briefSummary': "The removable functional appliance's goal is to restore functional balance (breathing, swallowing, chewing, etc.) and muscular balance (facial muscles, etc.) in the child. This promotes the establishment of a harmonious and stable occlusion.. The objective of this study is to investigate the benefits of an orthodontic device (removable functional appliance ) in the management of malocclusions/orofacial dysfunctions"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who had a malocclusion and/or a dysfunction which can be treated by removable functionnal appliance.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who had a malocclusion and/or a dysfunction which can be treated by removable functionnal appliance\n\nExclusion Criteria:\n\n* Patients who don't need a removable functionnal appliance."}, 'identificationModule': {'nctId': 'NCT07127328', 'briefTitle': 'Benefits of an Orthodontic Device Removable Functional Appliance in the Management of Malocclusions/Orofacial Dysfunctions', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Benefits of an Orthodontic Device (Removable Functional Appliance in the Management of Malocclusions/Orofacial Dysfunctions', 'orgStudyIdInfo': {'id': '25Odonto04'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Patient with removable funcitonal appliance', 'type': 'DEVICE', 'otherNames': ['orthodontic treatment'], 'description': 'Patients who have a malocclusion and/or a dysfunction treated by removable functional appliance'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'state': 'Alpes Maritimes', 'country': 'France', 'facility': 'CHU NICE', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'Carole Charavet', 'role': 'CONTACT', 'email': 'charavet.c@chu-nice.fr', 'phone': '04 92 03 30 07'}, {'name': 'Rachida YATIMI', 'role': 'CONTACT', 'email': 'yatimi.r@chu-nice.fr', 'phone': '0492033007'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}