Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-29 @ 3:44 AM
Study NCT ID:
NCT03966703
Status:
COMPLETED
Last Update Posted:
2019-05-29
First Post:
2019-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Masticatory Efficiency in Implant-fixed Complete Dentures Compared to the Conventional Dentures
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'], 'maskingDescription': 'patients are computer sorted in each group. samples were anonymous tagged by numbers and not by patient name'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '10 patients from each group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-25', 'studyFirstSubmitDate': '2019-05-22', 'studyFirstSubmitQcDate': '2019-05-25', 'lastUpdatePostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'color analysis mixing test', 'timeFrame': 'from 5 up to 20 second', 'description': 'a two color chewing gum is chewed for a specific number of cycles, gum is scanned and color mixing is analysed by a software called View Gum'}], 'secondaryOutcomes': [{'measure': 'weight reduction', 'timeFrame': 'from 5 up to 20 second', 'description': 'gum is weighted before each chewing cycle than dried and weighted after chewing.weight reduction is the secondary outcome for mastication efficiency analyzing'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['complete denture', 'implant-fixed denture', 'masticatory efficiency', 'mixing ability test'], 'conditions': ['Mastication']}, 'descriptionModule': {'briefSummary': "Purpose of this study is to compare the masticatory efficiency 'All on four' to 'Complete dentures on a class I ridge' with a color mixing analyzing test. Ten Patients with fixed complete dentures on implants and other ten patients with complete denture on a class I ridge (Atwood) had chewed a bicolor chewing gum (Hubba Bubba ®) for different number of cycles(5-10-15-20). The chewed gum is retrieved scanned and weighted to quantify masticatory efficiency"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* good general health, good intraoral conditions, and dentures in satisfactory conditions over edentulous high ridge Atwood's Class I. The minimum time of complete denture use ranged from 3 to 6 months. no temporomandibular dysfunction\n\nExclusion Criteria:\n\n\\-"}, 'identificationModule': {'nctId': 'NCT03966703', 'briefTitle': 'Masticatory Efficiency in Implant-fixed Complete Dentures Compared to the Conventional Dentures', 'organization': {'class': 'OTHER', 'fullName': 'St Joseph University, Beirut, Lebanon'}, 'officialTitle': 'Masticatory Efficiency in Implant-fixed Complete Dentures Compared to the Conventional Dentures: a Randomized Clinical Trial by Color Mixing Analysis Test.', 'orgStudyIdInfo': {'id': 'USJ -2017-65'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'conventional denture', 'description': '10 patients chewed a 2 color gum for 5 cycles 10, 15 and 20.each sample is retrieved weighted and scanned', 'interventionNames': ['Behavioral: mixing analysing test']}, {'type': 'EXPERIMENTAL', 'label': 'implant fixed denture', 'description': '10 patients chewed a 2 color gum for 5 cycles 10, 15 and 20.each sample is retrieved weighted and scanned', 'interventionNames': ['Behavioral: mixing analysing test']}], 'interventions': [{'name': 'mixing analysing test', 'type': 'BEHAVIORAL', 'otherNames': ['gum weight', 'hubba bubba'], 'description': 'The chewed gum is retrieved scanned and weighted to quantify masticatory efficiency', 'armGroupLabels': ['conventional denture', 'implant fixed denture']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Saint Joseph University', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'overallOfficials': [{'name': 'Elie Jasser, DSD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Master student in aesthetic and prosthetic dentistry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St Joseph University, Beirut, Lebanon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master student in aesthetic and prosthetic dentistry. Principal investigator', 'investigatorFullName': 'Elie Jasser', 'investigatorAffiliation': 'St Joseph University, Beirut, Lebanon'}}}}