Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT05912127
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2023-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
All on Four Versus All on Three Implant Treatment Concepts
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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be classified into 2 groups according to the implant treatment concept they received:\n\n* Group 1 (control group); included 3 patients who received All on 4 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 2 vertical implants in the lateral incisor/canine areas.\n* Group 2 (test group); included 3 patients who received All on 3 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 1 vertical implant in the midline of the mandible.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-12', 'studyFirstSubmitDate': '2023-06-12', 'studyFirstSubmitQcDate': '2023-06-12', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patient satisfaction', 'timeFrame': 'one year', 'description': 'Patient satisfaction was evaluated using a questionnaire based on visual analog scale (VAS)'}, {'measure': 'crestal bone loss', 'timeFrame': 'Two year', 'description': 'bone loss was measured around the implants in mm'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prosthesis Durability']}, 'descriptionModule': {'briefSummary': 'the evaluation of patient satisfaction of All on-4 versus All on-3 implant treatment concepts rehabilitation of atrophied mandibular ridge.', 'detailedDescription': 'Patients will be classified into 2 groups according to the implant treatment concept they received:\n\n* Group 1 (control group); included patients who received All on 4 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 2 vertical implants in the lateral incisor/canine areas.\n* Group 2 (test group); included patients who received All on 3 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 1 vertical implant in the midline of the mandible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. All patients already have implants inserted in their mandibular ridges According to the All on 4 or All on 3 concepts.\n\n 2\\. They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetes or osteoporosis. This was achieved through medical history and clinical examination by the physician.\n\n 3\\. All patients have sufficient inter-arch space. 4. All patients are of angle class I maxillo-mandibular relationships. 5. All patients had maxillary conventional complete dentures.\n\nExclusion Criteria:\n\n1\\. Any neuromuscular disorders 2. Uncooperative patients\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05912127', 'briefTitle': 'All on Four Versus All on Three Implant Treatment Concepts', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'All On-4 Versus All o-3 Implant Treatment Concepts for Rehabilitation of Atrophied Mandibular Ridge. A Study of Patient Satisfaction', 'orgStudyIdInfo': {'id': 'A09071221'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '• Group 1 (control group)', 'description': 'patients who received All on 4 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 2 vertical implants in the lateral incisor/canine areas.', 'interventionNames': ['Device: implant supported fixed full arch prosthesis']}, {'type': 'ACTIVE_COMPARATOR', 'label': '• Group 2 (test group);', 'description': 'patients who received All on 3 implant-supported fixed restoration. The patients received 2 inclined implants anterior to the mental foramina and 1 vertical implant in the midline of the mandible.', 'interventionNames': ['Device: implant supported fixed full arch prosthesis']}], 'interventions': [{'name': 'implant supported fixed full arch prosthesis', 'type': 'DEVICE', 'description': 'the patients will receive screw-retained cast metal-ceramic fixed prostheses that replace lost gingival tissues with pink porcelain.', 'armGroupLabels': ['• Group 1 (control group)', '• Group 2 (test group);']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'P.O.Box:35516', 'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Christine Ibrahim', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Mostafa Elsyad, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'professor of prosthodontics, Faculty of dentistry , Mansoura University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}