Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-01-01 @ 12:17 PM
Study NCT ID:
NCT06402656
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-31
First Post:
2024-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Customized and Standard Facemasks for Early Treatment of Class III Malocclusion
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': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2024-05-02', 'studyFirstSubmitQcDate': '2024-05-06', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Questionnaire on the preference of the patient for one of the two types of face masks', 'timeFrame': '4 months', 'description': 'The primary endpoint is a questionnaire on the preference between the two types of face masks at the end of the second phase of therapy (4 months after delivery of the first face mask)'}], 'secondaryOutcomes': [{'measure': 'Pain reported by patients', 'timeFrame': 'At 2 weeks and at 2 months after delivery of each of the 2 face masks', 'description': 'Pain measured through Visual Analogue Scale with minimum value of 0 and maximum value of 10. Higher scores mean worse pain.'}, {'measure': 'Difficulty in sleeping reported by patients', 'timeFrame': 'At 2 weeks and at 2 months after delivery of each of the 2 face masks', 'description': 'Difficulty in sleeping measured through VAS Visual Analogue Scale with minimum value of 0 and maximum value of 10. Higher scores mean more difficulty in sleeping.'}, {'measure': 'Number of complications', 'timeFrame': 'At 2 weeks and at 2 months after delivery of each of the 2 face masks', 'description': 'Number of complications'}, {'measure': 'Total time wear', 'timeFrame': 'At 2 months after delivery of each of the 2 face masks', 'description': 'Total time wear measured with a thermosensor (Theramon)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malocclusion, Angle Class III', 'Extraoral Traction Appliances']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare a customized facemask for the treatment of Class III malocclusion in the prepubertal growing patient (patients between the ages of 5 and 12 years) versus a standard commercial facemask. Specifically, preference, pain, difficulty in sleeping, time of use, and possible complications for the two types of facemasks will be analyzed.\n\nThis is a single-center, national, controlled, superiority, randomized, crossover, open-label study.\n\nEach patient will be treated with both the customized facemask and the standard commercial facemask. Each patient will wear one type of facemask for 2 months and the other type of facemask for the next 2 months. After 2 weeks and at the end of therapy with each of the facemask types, the patient, with the possible help of the parents, will have to answer a questionnaire about pain and difficulty sleeping and report any complications. In addition, after completing both phases (fourth month), the patient should indicate a preference for one of the two types of mask with which to complete therapy for an additional 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 5 and 12 years;\n* Class III malocclusion, for which early orthopedic treatment with rapid maxillary expander and facemask is indicated.\n* signing of informed consent\n\nExclusion Criteria:\n\n* Cleft lip and/or palate.\n* Craniofacial syndromes.'}, 'identificationModule': {'nctId': 'NCT06402656', 'briefTitle': 'Comparison of Customized and Standard Facemasks for Early Treatment of Class III Malocclusion', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero-Universitaria Careggi'}, 'officialTitle': 'Comparison of Customized and Standard Facemasks for Early Treatment of Class III Malocclusion: Randomized Crossover Study', 'orgStudyIdInfo': {'id': 'LF14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Customized facemask', 'interventionNames': ['Device: Customized facemask']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard facemask', 'interventionNames': ['Device: Standard facemask']}], 'interventions': [{'name': 'Customized facemask', 'type': 'DEVICE', 'description': "The customized face mask will be fabricated from a 3D digital image of the patient's face obtained by means of a 3D scanner. Such a scanner consists of 6 digital SLR cameras and software capable of processing a 3-D image of the patient's face exportable as an stl file.", 'armGroupLabels': ['Customized facemask']}, {'name': 'Standard facemask', 'type': 'DEVICE', 'description': 'The standard facemask is the commercially available Petit standard facemask', 'armGroupLabels': ['Standard facemask']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD will be shared on appropriate request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero-Universitaria Careggi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}