Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-02-25 @ 8:11 PM
Study NCT ID:
NCT02907450
Status:
COMPLETED
Last Update Posted:
2016-09-20
First Post:
2016-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TolTwiCare : Qualitative Evaluation Routine Care From Primary Tolerance of a Prefabricated and Removable Orthosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-14', 'studyFirstSubmitDate': '2016-09-09', 'studyFirstSubmitQcDate': '2016-09-14', 'lastUpdatePostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'No appearance of more than one injury that can not be attributed to causes other than the orthosis', 'timeFrame': '11 weeks'}], 'secondaryOutcomes': [{'measure': 'The clinical evaluation of the compliance of the orthosis (occurrence of tooth movement, state of the brace, usual patient interview)', 'timeFrame': '11 weeks'}, {'measure': 'The subjective assessment of the compliance of wearing the brace by patient by self questionnaire', 'timeFrame': '11 weeks'}, {'measure': 'The subjective assessment of patient acceptability questionnaires self treatment', 'timeFrame': '11 weeks'}, {'measure': 'The support type envisaged endline by the doctor', 'timeFrame': '11 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dentofacial Functional Disorder']}, 'descriptionModule': {'briefSummary': 'The TwiCare® device is a removable brace that can be used in orthopedic referred to stimulate mandibular growth or in interception / contention.\n\nThe proposed research project will focus initially on assessing the comfort and safety of TwiCare® device. The orthopedic efficiency therefore not part of this study.\n\nThe comfort and safety of the brace will be evaluated firstly by the practitioner during the visit control around 2 ½ months (or 11 weeks) after the start of the port of the device, and with the help of a questionnaire completed by the patient at home 3 weeks and 6 weeks after the start of the port of the device, and during the control visit at 11 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* male or female patients, where the laying of a brace phase of interception or contention after dental-facial orthodontic treatment is indicated (an intended age range of 8-18 years, not exhaustive or limiting) , recipient of a social security scheme, for which a management of the orthosis is acquired.\n* incisor width compatible with the sizes of TwiCare® orthotics available, according to manufacturer's recommendations\n* patient in good general health\n* parent or guardian able to receive clear information, and express their opposition not to the patient's participation in this research\n* for patients with malocclusions, the incisors (maxillary and mandibular) should be aligned.\n\nExclusion Criteria:\n\n* General chronic health problem, unbalanced\n* obvious oral ventilation\n* history of temporomandibular dysfunction\n* nocturnal episodes of severe bruxism\n* unbalanced periodontal disease\n* allergies or intolerances known to one of the constituents of the orthosis\n* opposition of representatives of the parental authority (parent or guardian) or the patient himself at the patient's participation in this research\n* patient unable to respond to the questionnaire\n* monitoring difficulties (going on holiday, imminent change, remoteness, lack of motivation)\n* simultaneous participation in intervention research\n* pregnant Patient on examination of the latter, according to his age\n* Incisive (maxilla and / or mandible) unaligned"}, 'identificationModule': {'nctId': 'NCT02907450', 'acronym': 'TolTwiCare', 'briefTitle': 'TolTwiCare : Qualitative Evaluation Routine Care From Primary Tolerance of a Prefabricated and Removable Orthosis', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'orgStudyIdInfo': {'id': 'BRD/11/2-W'}, 'secondaryIdInfos': [{'id': '2011-A01106-35', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinical evaluation of the tolerance of the orthosis', 'interventionNames': ['Device: TwiCare®.']}], 'interventions': [{'name': 'TwiCare®.', 'type': 'DEVICE', 'armGroupLabels': ['Clinical evaluation of the tolerance of the orthosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': "CHU de Nantes -Service d'Odontologie Restauratrice et Chirurgicale", 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}