Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT06789627
Status:
COMPLETED
Last Update Posted:
2025-01-27
First Post:
2025-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oral Health Related Quality of Life in Cad Metallic and Poly Ether Ether Ketone (Peek) Partial Denture Frameworks in Mandibular Kennedy Class I Cases
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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2025-01-17', 'studyFirstSubmitQcDate': '2025-01-17', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oral Health Related Quality of Life (OHRQoL)', 'timeFrame': '2 years', 'description': 'measured by Oral Health Impact Profile- 14 Minimum score 0 , Maximum score 56 higher scores indicate worse OHRQoL'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CAD/CAM', 'Digital metallic RPD', 'patient centered outcomes', '3D printing', 'PEEK', 'OHIP-14'], 'conditions': ['Partial Edentulism', 'Oral Health-Related Quality of Life']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to compare CAD Poly ether ether ketone (PEEK) RPD to CAD metallic RPD in treating partial edentulism in terms of Oral health related quality of life'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with bilateral free end saddles in the mandible (Kennedy class I) with the last standing abutment second premolar\n* Opposing dentition is fully intact or restored to be intact\n* Adequate inter-arch space of at least 7mm\n* Angle's class I maxilla-mandibular relationship\n* Patients with no periodontal disease and good oral hygiene\n* Cooperative patients showing motivation to follow-up\n\nExclusion Criteria:\n\n* Periodontal affection of the abutment teeth\n* Skeletal mal-relationship\n* Unmotivated patients to maintain adequate oral hygiene and to follow up---- ---- Patients with neuro-mascular disorders\n* Systemic disease affecting periodontal health like uncontrolled diabetes"}, 'identificationModule': {'nctId': 'NCT06789627', 'briefTitle': 'Oral Health Related Quality of Life in Cad Metallic and Poly Ether Ether Ketone (Peek) Partial Denture Frameworks in Mandibular Kennedy Class I Cases', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Indirect CAD/CAM Removable Partial Denture Frameworks: a Comparative Study', 'orgStudyIdInfo': {'id': 'HendHegazi'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RPD with metallic framework', 'description': 'Indirectly CAD/CAM produced Metallic framework', 'interventionNames': ['Other: RPD with metallic framework']}, {'type': 'EXPERIMENTAL', 'label': 'RPD with PEEK framework', 'description': 'Indirectly CAD/CAM produced PEEK framework', 'interventionNames': ['Other: RPD with PEEK framework']}], 'interventions': [{'name': 'RPD with PEEK framework', 'type': 'OTHER', 'description': 'Indirectly CAD/CAM produced PEEK framework', 'armGroupLabels': ['RPD with PEEK framework']}, {'name': 'RPD with metallic framework', 'type': 'OTHER', 'description': 'Indirectly CAD/CAM produced metallic RPD', 'armGroupLabels': ['RPD with metallic framework']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0', 'city': 'Cairo', 'state': 'Giza Governorate', 'country': 'Egypt', 'facility': 'Faculty of dentistry, Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prinicipal investigator', 'investigatorFullName': 'Hend Mahmoud Mohamed Hegazi', 'investigatorAffiliation': 'Cairo University'}}}}