Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-02-03 @ 9:34 AM
Study NCT ID:
NCT04056559
Status:
COMPLETED
Last Update Posted:
2019-08-14
First Post:
2019-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normative Assessment of Adaptable Mouthguards.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009912', 'term': 'Oral Manifestations'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2012-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2019-08-13', 'studyFirstSubmitQcDate': '2019-08-13', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact on ventilatory flow rate by minute', 'timeFrame': 'At Week 51', 'description': 'Average of measured values in one minute, compared to maximum aerobic reference speed of the subject\n\nModification of the ventilatory flow rate by min'}, {'measure': 'Impact on O2 consumption', 'timeFrame': 'At Week 51', 'description': 'Average of measured values in one minute, compared to reference of the subject'}, {'measure': 'Impact on respiratory rate', 'timeFrame': 'At Week 51', 'description': 'Average of measured values in one minute, compared to reference of the subject'}, {'measure': 'Impact on current volume', 'timeFrame': 'At Week 51', 'description': 'Average of measured values in one minute, compared to reference of the subject'}, {'measure': 'Impact on CO2 production', 'timeFrame': 'At Week 51', 'description': 'Average of measured values in one minute, compared to reference of the subject'}, {'measure': 'Impact on comfort according an analogical visual scale for 11 criteria', 'timeFrame': 'At Week 51', 'description': 'According an analogical visual scale (from 0 to 10) for 11 criteria (retention, muco-gingival appearance, mouth opening height, volume of mouthguards, nausea, phonation, open mouth ventilation, tight jaw ventilation, salivation, masticatory muscles, temporomandibular joint)'}, {'measure': 'Impact on electromyographic recording', 'timeFrame': 'At Week 52', 'description': 'The electromyographic activity will be amplified and filtered (bandwidth 10-1000 Hz). The signals will be digitized using a CED 1401 interface coupled to a microcomputer that is controlled by the "SPIKE2" software. The digitization frequency will be 2,000 Hz. The software "SPIKE2" will then calculate what is called "integrated electromyogram": the electromyographic signals will be rectified and filtered with a moving average having a period of 0,2 seconds.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prototype', 'Adaptable mouthguards'], 'conditions': ['Oral Manifestations']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to the validate adaptable mouthguards prototypes, patented by Bordeaux University and Bordeaux University Hospital.', 'detailedDescription': 'The current state of knowledge in the areas of mouthguards shows that type II (adaptable) models account for 90% of the mouthguards of the sporting population. But a majority of these devices do not appear to comply with the European Directive 89/686 / European Economic Community.\n\nA previous work consisted of the production of prototypes of mouthguards meeting the essential requirements of the directive. These prototypes were the subject of a patent filed by the Bordeaux University and the Bordeaux University Hospital.\n\nThe aim of this study is to the validate the prototypes for a future launch on the market.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject aged 18 to 35,\n* Subject affiliated to a social security,\n* Subject who has signed the free and informed consent form.\n\nExclusion Criteria:\n\n* Subject with a pathology incompatible with the performance of the test, namely: Recent infarction,Threat syndrome, blood pressure resting\\> 200/120 mmHg, uncompensated cardiac insufficiency, atrioventricular block 3rd degree acquired, Myocarditis, Pericarditis, Endocarditis, Aortic Dissection, Intracardiac Tumor or Thrombus, Deep Vein Thrombosis, Pulmonary Embolism,\n* Subject under B-mimetic drug treatment,\n* Subject under safeguard of justice,\n* Subject participating in another search,\n* Subject during pregnancy.'}, 'identificationModule': {'nctId': 'NCT04056559', 'acronym': 'ENORMPIBA', 'briefTitle': 'Normative Assessment of Adaptable Mouthguards.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Normative Assessment of Adaptable Mouthguards.', 'orgStudyIdInfo': {'id': 'CHU Bx 2011/04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SIngle arm', 'description': 'The research is based on a population of men and women practicing a sport at risk of oral trauma.', 'interventionNames': ['Device: Adaptable mouthguards']}], 'interventions': [{'name': 'Adaptable mouthguards', 'type': 'DEVICE', 'description': 'Validate a prototype of Adaptable Intra-Oral Protections patented by Bordeaux University and Bordeaux University Hospital according to 3 levels (ventilation, comfort, cervical muscle activity).', 'armGroupLabels': ['SIngle arm']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Philippe POISSON, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}