Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-01 @ 12:21 PM
Study NCT ID:
NCT06866067
Status:
COMPLETED
Last Update Posted:
2025-03-10
First Post:
2025-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Clip Material on the Retention of Implant Supported Mandibular Overdenture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2025-02-25', 'studyFirstSubmitQcDate': '2025-03-06', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overdenture retention assessed using Universal Testing Machine (Newton)', 'timeFrame': 'From enrollment and after 3 months and finally at the end of treatment at 6 months', 'description': "Denture resistance corresponding to vertical displacement force was obtained using a universal testing machine (INSTRON, United States) to measure retention. Each patient had his chin securely fixed on a support while seated upright. The attachment portion of the universal machine was adjusted in accordance with the device's bar being securely attached to the denture. The device gradually increased the vertical load by 10 mm per minute until the denture completely fell out of place. A tuck sound can be heard to indicate the load at the dislodgment point. Additionally, the force plot in the recorded computer software data exhibits an abrupt drop (Nexyge; Lloyd Instruments; MT-4.6). Each test was repeated five times to obtain five records, and the mean of these records was calculated. Testing was carried out on the mandibular overdenture after insertion, as well as at 3 and 6 months."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Denture Retention']}, 'descriptionModule': {'briefSummary': 'This study is aiming to evaluate the retention of implant supported mandibular overdenture using two different clip materials namely polyoxymethylene (POM) and poly-ether-ether-ketone (PEEK) on PEEK bar at three-time intervals; immediately after placement, after 3 months and after 6 months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '50 Years', 'genderBased': True, 'genderDescription': 'bone density', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria:\n\n * Male.\n * Completely edentulous.\n * Age: 50-60 years.\n * Free from any systemic diseases that affect bone metabolism.\n * Good intraoral condition.\n * Anterior mandibular bone height \\> 13mm and width \\> 5mm.\n * The inter-arch space from 15mm to 17mm.\n\nExclusion criteria:\n\n* Smoking and drug abusing.\n* Severe maxillomandibular skeletal discrepancy.\n* Bone metabolic disorders.\n* History of head and neck radiotherapy.\n* Intravenous bisphosphonate therapy.\n* Presence of para-functional habits.\n* Temporomandibular joint disorders.\n* Severe bony undercuts.'}, 'identificationModule': {'nctId': 'NCT06866067', 'briefTitle': 'The Effect of Clip Material on the Retention of Implant Supported Mandibular Overdenture', 'organization': {'class': 'OTHER', 'fullName': 'MTI University'}, 'officialTitle': 'The Effect of Clip Material on the Retention of Implant Supported Mandibular Overdenture: Clinical Comparative Study', 'orgStudyIdInfo': {'id': '970/6525'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PEEK clip', 'description': 'Clip for overdenture retention made from poly-ether-ether-ketone (PEEK)', 'interventionNames': ['Device: PEEK clip']}, {'type': 'OTHER', 'label': 'Nylon clip', 'description': 'Clip for overdenture retention made from nylon (C6H11NO)n', 'interventionNames': ['Device: Nylon clip']}], 'interventions': [{'name': 'PEEK clip', 'type': 'DEVICE', 'description': 'The overdentures were attached with PEEK clip . The retention of overdenture was assessed', 'armGroupLabels': ['PEEK clip']}, {'name': 'Nylon clip', 'type': 'DEVICE', 'description': 'The overdentures were attached with Nylon clip . The retention of overdenture was assessed', 'armGroupLabels': ['Nylon clip']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'MTI University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MTI University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Removable Prosthodontics', 'investigatorFullName': 'Sara Medhat Mohamed Ali', 'investigatorAffiliation': 'MTI University'}}}}