Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT04422093
Status:
WITHDRAWN
Last Update Posted:
2025-04-13
First Post:
2020-06-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring System for the Wearing of Orthodontic Elastics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The device was found to be too bulky, and therefore we decided not to enrol any subjects.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2020-06-04', 'studyFirstSubmitQcDate': '2020-06-04', 'lastUpdatePostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comfort of the device', 'timeFrame': '6 months', 'description': 'The wearing comfort for the patient is ok/not ok'}, {'measure': 'Handling of the device', 'timeFrame': '6 months', 'description': 'The handling for the therapist is ok/not ok'}], 'secondaryOutcomes': [{'measure': 'cooperation', 'timeFrame': '6 months', 'description': 'read on the sensors how long the patients followed the instructions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Medical Device Complication']}, 'referencesModule': {'references': [{'pmid': '20966997', 'type': 'BACKGROUND', 'citation': 'Mizrahi E. Risk management in clinical practice. Part 7. Dento-legal aspects of orthodontic practice. Br Dent J. 2010 Oct 23;209(8):381-90. doi: 10.1038/sj.bdj.2010.926.'}, {'pmid': '28651764', 'type': 'BACKGROUND', 'citation': 'Al-Moghrabi D, Salazar FC, Pandis N, Fleming PS. Compliance with removable orthodontic appliances and adjuncts: A systematic review and meta-analysis. Am J Orthod Dentofacial Orthop. 2017 Jul;152(1):17-32. doi: 10.1016/j.ajodo.2017.03.019.'}, {'pmid': '31143922', 'type': 'BACKGROUND', 'citation': 'Huanca Ghislanzoni L, Ameur S, Antonarakis GS, Kiliaridis S. Headgear compliance as assessed by a temperature-sensitive recording device: a prospective clinical study. Eur J Orthod. 2019 Nov 15;41(6):641-645. doi: 10.1093/ejo/cjz036.'}, {'pmid': '20963543', 'type': 'BACKGROUND', 'citation': 'Schott TC, Goz G. Applicative characteristics of new microelectronic sensors Smart Retainer(R) and TheraMon(R) for measuring wear time. J Orofac Orthop. 2010 Sep;71(5):339-47. doi: 10.1007/s00056-010-1019-3. Epub 2010 Oct 21. English, German.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to validate a novel sensor intended to measure the wearing time of orthodontic elastics in patients with multibracket appliances. The newly developped sensor will be tested in 42 patients over a period of 6 months', 'detailedDescription': "Fixed multibracket appliances are used to correct tooth and jaw malocclusions. Usually, elastics are inserted between the upper and lower jaws to adjust the position of the jaws in relation to each other. The wearing time of the elastics determines the duration of the treatment and the quality of the treatment results. While micro-sensors are increasingly used for removable appliances to monitor patient compliance, there is still no such possibility for fixed appliances. This gap is to be closed with the planned 'OrthoKontrol' (intraoral mini-sensor). This is intended to measure and record the wearing time of the elastics."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '11 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with class II malocclusion in treatment with fixed appliances', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Multibracket appliances (fixed braces) in both jaws\n* Need for intermaxillary elastics on at least one side\n* Minimum motor skills\n\nExclusion Criteria:\n\n* Patients with general diseases\n* Patients with inflammatory oral diseases\n* Patients with physical disabilities, which make it impossible to cooperate\n* Independent insertion of the elastics is not possible\n* Patients with impaired judgment Pregnant women'}, 'identificationModule': {'nctId': 'NCT04422093', 'acronym': 'OK', 'briefTitle': 'Monitoring System for the Wearing of Orthodontic Elastics', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'OrthoKontrol - System Zur Überwachung Der Tragedauer Von kieferorthopädischen Gummizügen', 'orgStudyIdInfo': {'id': 'OrthoKontrol'}}, 'armsInterventionsModule': {'interventions': [{'name': 'OrthoKontrol', 'type': 'DEVICE', 'description': 'Fixing OrthoKontrol Sensor on multibracket appliance to measure cooperation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4056', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'University Center for Dental Medicine UZB', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Carlalberta Verna', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Center for Dental Medicine, Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}