Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-28 @ 8:49 PM
Study NCT ID:
NCT05999760
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2023-08-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retention, Chewing Efficiency and Masticatory Performance of Partial Dentures Opposing Implant Retained Prosthesis.
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': 'each patient was not informed about material of received prosthesis'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-13', 'studyFirstSubmitDate': '2023-08-06', 'studyFirstSubmitQcDate': '2023-08-13', 'lastUpdatePostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluation of change of retention of versacrylic and CAD/CAM partial denture', 'timeFrame': 'on day 1 ,1 month and 2months of prosthesis delivery', 'description': 'measurement of retention of partial dentures made of Versacryle and CAD/CAM technology'}, {'measure': 'evaluation of change of chewing efficiency of versacrylic and CAD/CAM partial denture', 'timeFrame': 'on day 1 ,1 month and 2months of prosthesis delivery', 'description': 'measurement of chewing efficiency of partial dentures made of Versacryle and CAD/CAM technology'}, {'measure': 'evaluation of change of masticatory performance of versacrylic and CAD/CAM partial denture', 'timeFrame': 'on day 1,1 month and 2months of prosthesis delivery', 'description': 'measurement of masticatory performance of partial dentures made of Versacryle and CAD/CAM technology'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Retention', 'Chewing efficiency', 'Removable Prosthodontics'], 'conditions': ['Implant Site Reaction', 'Implant Complication']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate retention ,chewing efficiency and masticatory performance of flexible versus CAD/CAM partial dentures opposing to fixed implant retained restorations.', 'detailedDescription': 'in this study 22 patients will be selected following inclusion and exclusion criteria. The patients will be divided randomly into two groups.\n\nGroup I patients will receive Versacrylic removable partial denture. group II patients will receive CAD/CAM removable partial denture all patients will be given the home care instructions at night and brush cleaning of the dentures.\n\nMeasurements of retention using universal testing machine, masticatory performance using T-scan III computerized system and chewing efficiency using chewing function questionnaire'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-smoker male Patients\n* Age ranging from 40-50 years.\n* Highly cooperative and motivated patients.\n* Patients Systemically free from any immunosuppressive diseases.\n* Patients free from Diabetes, Hypertension, Cancer, any mental or physical diseases.\n* Patients not receiving any Radiotherapy or chemotherapy treatment.\n\nExclusion Criteria:\n\n* Female patients\n* Smoker patients.\n* Age exceeding 50 years\n* Uncooperative and unmotivated patients.'}, 'identificationModule': {'nctId': 'NCT05999760', 'briefTitle': 'Retention, Chewing Efficiency and Masticatory Performance of Partial Dentures Opposing Implant Retained Prosthesis.', 'organization': {'class': 'OTHER', 'fullName': 'National Research Centre, Egypt'}, 'officialTitle': 'Retention, Chewing Efficiency and Masticatory Performance of Maxillary Flexible Versus Computer Aided Design/Computer Aided Manufacture(CAD/CAM) Partial Dentures Opposing Fixed Implant Retained Prosthesis.', 'orgStudyIdInfo': {'id': 'Elhotieby.M'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I (patients received Versacryle removable partial denture)', 'description': 'patients having Kennedy class I received maxillary Versacryle removable partial denture', 'interventionNames': ['Device: evaluation of retention of Versacryle and CAD/CAM partial dentures by force gauge', 'Device: chewing efficiency by electromyograph(E.M.G)', 'Other: masticatory performance(questionnaire)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II (patients received CAD/CAM fabricated removable partial denture)', 'description': 'patients having Kennedy class I received maxillary CAD/CAM fabricated removable partial denture', 'interventionNames': ['Device: evaluation of retention of Versacryle and CAD/CAM partial dentures by force gauge', 'Device: chewing efficiency by electromyograph(E.M.G)', 'Other: masticatory performance(questionnaire)']}], 'interventions': [{'name': 'evaluation of retention of Versacryle and CAD/CAM partial dentures by force gauge', 'type': 'DEVICE', 'description': 'Evaluation of retention of Versacryle and CAD/CAM partial dentures by force gauge on day one, on first month, and on the second month of prosthesis delivery.', 'armGroupLabels': ['Group I (patients received Versacryle removable partial denture)', 'Group II (patients received CAD/CAM fabricated removable partial denture)']}, {'name': 'chewing efficiency by electromyograph(E.M.G)', 'type': 'DEVICE', 'description': 'Evaluation of chewing efficiency of Versacryle and CAD/CAM partial dentures by force gauge on day one, on first month, and on the second month of prosthesis delivery.', 'armGroupLabels': ['Group I (patients received Versacryle removable partial denture)', 'Group II (patients received CAD/CAM fabricated removable partial denture)']}, {'name': 'masticatory performance(questionnaire)', 'type': 'OTHER', 'description': 'Evaluation of masticatory performance of Versacryle and CAD/CAM partial dentures by questionnaire on day one, on first month, and on the second month of prosthesis delivery.', 'armGroupLabels': ['Group I (patients received Versacryle removable partial denture)', 'Group II (patients received CAD/CAM fabricated removable partial denture)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12622', 'city': 'Giza', 'country': 'Egypt', 'facility': 'National Research Centre', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Menatallah Elhotieby, Researcher', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Research Centre, Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Research Centre, Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator Researcher fixed and removable prosthodontics', 'investigatorFullName': 'Menatallah Mohamed Elhotieby', 'investigatorAffiliation': 'National Research Centre, Egypt'}}}}