Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:19 AM
Study NCT ID:
NCT07413003
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Orthodontic Aligner Treatment Protocols Managed Through Remote Monitoring Versus In-Person Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2026-01-30', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment adherence', 'timeFrame': 'From enrollment through the monitoring phase of approximately 4 months.', 'description': 'The assessment and quantification will be carried out using a dedicated record. A clinical evaluation will also be performed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mild Intellectual Disability']}, 'referencesModule': {'references': [{'pmid': '36997411', 'type': 'RESULT', 'citation': 'Ferlito T, Hsiou D, Hargett K, Herzog C, Bachour P, Katebi N, Tokede O, Larson B, Masoud MI. Assessment of artificial intelligence-based remote monitoring of clear aligner therapy: A prospective study. Am J Orthod Dentofacial Orthop. 2023 Aug;164(2):194-200. doi: 10.1016/j.ajodo.2022.11.020. Epub 2023 Mar 28.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess patient adherence to orthodontic treatment with dental aligners delivered through remote monitoring compared with in-person care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 11 and 12 years\n* Diagnosis of mild intellectual disability\n* Presence of dental malocclusion requiring orthodontic treatment with aligner\n\nExclusion Criteria:\n\n\\- Presence of dental malocclusion requiring orthodontic treatment with a fixed appliance'}, 'identificationModule': {'nctId': 'NCT07413003', 'briefTitle': 'Comparison of Orthodontic Aligner Treatment Protocols Managed Through Remote Monitoring Versus In-Person Care', 'organization': {'class': 'OTHER', 'fullName': 'Oasi Research Institute-IRCCS'}, 'officialTitle': 'Comparison of Orthodontic Aligner Treatment Protocols Managed Through Remote Monitoring Versus In-Person Care', 'orgStudyIdInfo': {'id': 'RC-2794677 (aligners)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remote monitoring aligner', 'interventionNames': ['Device: Remotely monitored orthodontic aligner treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'In-person care monitoring aligner', 'interventionNames': ['Device: In-person monitored orthodontic aligner treatment']}], 'interventions': [{'name': 'Remotely monitored orthodontic aligner treatment', 'type': 'DEVICE', 'description': 'Remotely monitored orthodontic aligner treatment', 'armGroupLabels': ['Remote monitoring aligner']}, {'name': 'In-person monitored orthodontic aligner treatment', 'type': 'DEVICE', 'description': 'In-person monitored orthodontic aligner treatment', 'armGroupLabels': ['In-person care monitoring aligner']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94018', 'city': 'Troina', 'state': 'EN', 'country': 'Italy', 'contacts': [{'name': 'Antonio Fallea', 'role': 'CONTACT', 'email': 'afallea@oasi.en.it', 'phone': '+39 3381113255'}], 'facility': 'Oasi Research Institute', 'geoPoint': {'lat': 37.78437, 'lon': 14.59605}}], 'centralContacts': [{'name': 'Antonio Fallea', 'role': 'CONTACT', 'email': 'afallea@oasi.en.it', 'phone': '+39 3381113255'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oasi Research Institute-IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}