Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT03018158
Status:
COMPLETED
Last Update Posted:
2018-04-11
First Post:
2016-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MR Images Variation With or Without Denture Wear
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019554', 'term': 'Dental Restoration Wear'}], 'ancestors': [{'id': 'D003793', 'term': 'Dental Restoration, Permanent'}, {'id': 'D017266', 'term': 'Dental Prosthesis'}, {'id': 'D011476', 'term': 'Prosthodontics'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-09', 'studyFirstSubmitDate': '2016-12-28', 'studyFirstSubmitQcDate': '2017-01-09', 'lastUpdatePostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Luminance standard deviation value on MR image', 'timeFrame': 'MR Imaging was collected with each condition.Through study completion, an average of 2 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Magnetic Resonance Imaging']}, 'descriptionModule': {'briefSummary': 'The objective of this study was to compare level of artifact while tongue at rest and in motion of dentulous subjects.', 'detailedDescription': 'The magnetic resonance imaging (MRI) is useful to diagnose soft tissue morphology, especially to detect cancer and disk displacement with temporomandibular disorders. The prevalence of tongue cancer may increase with ageing population. A clear MR image is indispensable for clinical diagnosis. However, tongue motion associated with the habitual or swallowing tongue movement may cause artifacts on MRI. This occurrence of motion artifact is speculated to be prominent with the patients without the occlusal support. The objective of this pilot study was to compare level of artifact while tongue at rest and in motion of dentulous subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* dentulous\n* edentulous classified Eichner' s classfication\n\nExclusion Criteria:\n\n* involuntary motion occurs during imaging\n* absolutely contraindicated or as a rule contraindicated of MRI examination\n* subjects have ferromagnetic metals in the oral cavity\n* subjects can not swallow naturally"}, 'identificationModule': {'nctId': 'NCT03018158', 'briefTitle': 'MR Images Variation With or Without Denture Wear', 'organization': {'class': 'OTHER', 'fullName': 'Nihon University'}, 'officialTitle': 'MR Images Variation With or Without Denture Wear. Motion Artifacts Related With Tongue Movements', 'orgStudyIdInfo': {'id': 'EC 15-019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'dentulous', 'description': 'MR Imaging was collected with condition at the tongue at rest position.'}, {'type': 'NO_INTERVENTION', 'label': 'edentulous without denture wear.', 'description': 'MR Imaging was collected without denture wear.'}, {'type': 'EXPERIMENTAL', 'label': 'edentulous with denture wear.', 'description': 'MR Imaging was collected with denture wear.', 'interventionNames': ['Device: denture wear.']}], 'interventions': [{'name': 'denture wear.', 'type': 'DEVICE', 'description': 'MR Imaging was collected with or without denture wear.', 'armGroupLabels': ['edentulous with denture wear.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2718587', 'city': 'Matsudo', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Nihon University Hospital', 'geoPoint': {'lat': 35.77995, 'lon': 139.90144}}], 'overallOfficials': [{'name': 'Yasuhiko Kawai, DDS MSc PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Nihon University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nihon University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Dr.Yasuhiko kawai', 'investigatorFullName': 'Yasuhiko Kawai', 'investigatorAffiliation': 'Nihon University'}}}}