Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-25 @ 2:20 PM
Study NCT ID:
NCT05290766
Status:
COMPLETED
Last Update Posted:
2025-01-17
First Post:
2022-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Two Versus Four Implant-supported Fixed Full-arch Prosthesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011475', 'term': 'Prosthesis Failure'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-04-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2022-03-02', 'studyFirstSubmitQcDate': '2022-03-11', 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog scale (VAS) questionnaire', 'timeFrame': 'one year', 'description': 'Regarding VAS, participants were asked to score their answer according to the amount of satisfaction on a 100mm line (Score zero = no satisfaction at all and score 100 = complete satisfaction). The questions cover several items related to prosthesis such as: retention, stability, comfort, ease of cleaning, ease of speaking, ease of chewing, limited activities due to embarrassment, quality of bolus and appearance'}], 'secondaryOutcomes': [{'measure': 'Quality of Life (Secondary Outcome).', 'timeFrame': 'one year', 'description': 'The oral Health impact profile (OHIP-14) questions were utilized to assess OHRQoL. The questions were composed of seven domains'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prosthesis Durability']}, 'descriptionModule': {'briefSummary': 'The aim of this study will be the evaluation of patient satisfaction and oral health-related-quality of life (OHRQoL) of two versus four implants supporting fixed full-arch screw-retained metal acrylic hybrid mandibular prosthesis.', 'detailedDescription': '* Six completely edentulous patients will be selected for this study from the outpatient clinic of the prosthodontic department\n* All patients will be informed about all surgical and prosthodontics procedures that will be done for them. All patients will sign the consent form of the ethical committee in faculty dentistry Mansoura University.\n\nThe patients will be divided into 2 groups\n\n1. Control group: will receive implant-supported mandibular fixed metal acrylic prosthesis on 4 implants that were placed according to the "All on four concept".\n2. Study group: will receive implant-supported mandibular fixed metal acrylic prosthesis on two implants placed according to "All On two concept".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Eligible patients needed must have Sufficient interarch space (at least 15 mm from the occlusal plane to the mandibular ridge) to provide space for fixed prosthesis construction all patients should be completely edentulous patients with resorbed mandibular ridge all patients must be angle class I\n\nExclusion Criteria:\n\n* systemic diseases that contraindicate implant placement bone metabolic diseases such as diabetes mellitus irradiation of the head and neck region chemotherapy within the past 3 years smoking habits.'}, 'identificationModule': {'nctId': 'NCT05290766', 'briefTitle': 'Two Versus Four Implant-supported Fixed Full-arch Prosthesis', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Two Versus Four Implant Supporting Fixed Full-arch Screw-retained Metal Acrylic Hybrid Mandibular Prosthesis.(A Study of Patient Satisfaction)', 'orgStudyIdInfo': {'id': 'A03040122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'will receive implant-supported mandibular fixed metal acrylic prosthesis on 4 implants that were placed according to the "All on four concept".', 'interventionNames': ['Procedure: placement of four dental implants', 'Device: mandibular full arch prosthesis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Study group', 'description': 'will receive implant-supported mandibular fixed metal acrylic prosthesis on two implants placed according to "All On two concept".', 'interventionNames': ['Procedure: placement of two dental implants', 'Device: mandibular full arch prosthesis']}], 'interventions': [{'name': 'placement of four dental implants', 'type': 'PROCEDURE', 'description': 'placement of four dental implants according to the " All on four concept"', 'armGroupLabels': ['Control group']}, {'name': 'placement of two dental implants', 'type': 'PROCEDURE', 'description': 'placement of two dental implants according to " All on two concepts"', 'armGroupLabels': ['Study group']}, {'name': 'mandibular full arch prosthesis', 'type': 'DEVICE', 'description': 'loading of the mandibular fixed full-arch screw-retained metal acrylic prosthesis', 'armGroupLabels': ['Control group', 'Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Eldakahlia', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}, {'zip': 'P.O.Box:35516', 'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Christine Ibrahim', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}