Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT04881669
Status:
COMPLETED
Last Update Posted:
2021-05-11
First Post:
2021-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Obturator Thickness on the Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-06', 'studyFirstSubmitDate': '2021-05-03', 'studyFirstSubmitQcDate': '2021-05-06', 'lastUpdatePostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the effect of bulb thickness', 'timeFrame': '3 weeks', 'description': 'measuring the efficacy of masticatory function with chewing test'}, {'measure': 'the effect of weight reduction', 'timeFrame': '3 weeks', 'description': 'measuring the weight differences of prostheses'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obturator, bulb'], 'conditions': ['Maxilla--Cancer']}, 'descriptionModule': {'briefSummary': 'the effect of obturator bulb thickness on masticatory function has been verified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '71 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* having maxillectomy operation\n\nExclusion Criteria:\n\n* having radiation therapy before the study'}, 'identificationModule': {'nctId': 'NCT04881669', 'acronym': 'obturator', 'briefTitle': 'The Effect of Obturator Thickness on the Function', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'The Effect of the Wall Thickness of Obturator Bulbs on Masticatory Function in Patients With Maxillectomy', 'orgStudyIdInfo': {'id': '1297'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low group', 'description': 'low thickness group', 'interventionNames': ['Device: obturator']}, {'type': 'EXPERIMENTAL', 'label': 'moderate group', 'description': 'moderate thickness group', 'interventionNames': ['Device: obturator']}, {'type': 'EXPERIMENTAL', 'label': 'high group', 'description': 'high thickness group', 'interventionNames': ['Device: obturator']}], 'interventions': [{'name': 'obturator', 'type': 'DEVICE', 'otherNames': ['bulb'], 'description': 'variable bulbs', 'armGroupLabels': ['high group', 'low group', 'moderate group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34452', 'city': 'Fatih', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul university,Faculty of Dentistry', 'geoPoint': {'lat': 39.94548, 'lon': 32.87302}}], 'overallOfficials': [{'name': 'merve benli, phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istanbul University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dr. Merve Benli', 'investigatorAffiliation': 'Istanbul University'}}}}