Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT06114069
Status:
COMPLETED
Last Update Posted:
2024-11-21
First Post:
2023-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prosthetic Management of All on Four Versus All on Six to Rehabilitate Completely Edentulous Maxillary Ridge Opposed by Natural Teeth
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': 'The patients were classified into 2 groups:\n\n1. Group I; 4 patients received 4-implant supported fixed prosthesis.\n2. Group II; 4 patients received 6-implant supported fixed prosthesis.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2023-10-29', 'studyFirstSubmitQcDate': '2023-10-29', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anterior area index', 'timeFrame': 'six months', 'description': 'outcome is being evaluated by radiograph'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prosthesis Survival']}, 'descriptionModule': {'briefSummary': 'the aim of the study to compare the anterior maxillary bone index changes for patient rehabilitated with implant supported fixed prosthesis opposed by natural teeth'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. All patient wearing a maxillary implant supported overdenture or implant supported fixed restoration and mandibular natural teeth or fixed restoration within natural dentition.\n\n 2\\. All patients were unsatisfied by the maxillary restoration and presented clear preference for a better prosthesis.\n\n 3\\. They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. This was achieved through medical history and clinical examination by physician.\n\n 4\\. At least one year passed after the last restoration. 5. At least 15 mm restorative space must be available (from the mucosa covering the crest of the residual ridge to proposed occlusal plane) to permit construction of all types of tested prosthesis (class I according to Ahuja and Cagna).195 This was detected by a tentative jaw relation.\n\nExclusion Criteria:\n\n* 1\\. Patients had head and neck radiotherapy, patients with bleeding disorders or hepatic patients.\n\n 2\\. Patients with metabolic disorders as diabetes mellitus, osteoporosis and hepatic disorders which might affect implant lifespan.\n\n 3\\. Long term immunosuppress and corticosteroid drug therapy. 4. Patient with abnormal habits as clenching and bruxism. 5. Smoking patient. 6. Uncooperative patients. 7. Neuromuscular diseases. 8. Patient with problems in TMJ.'}, 'identificationModule': {'nctId': 'NCT06114069', 'briefTitle': 'Prosthetic Management of All on Four Versus All on Six to Rehabilitate Completely Edentulous Maxillary Ridge Opposed by Natural Teeth', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Prosthetic Management of All on Four Versus All on Six to Rehabilitate Completely Edentulous Maxillary Ridge Opposed by Natural Teeth', 'orgStudyIdInfo': {'id': 'M07100522'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'all on four group', 'description': '4 patients received 4-implant supported fixed prosthesis', 'interventionNames': ['Procedure: implant supported maxillary fixed prosthesis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'all on six group', 'description': '4 patients received 6-implant supported fixed prosthesis', 'interventionNames': ['Procedure: implant supported maxillary fixed prosthesis']}], 'interventions': [{'name': 'implant supported maxillary fixed prosthesis', 'type': 'PROCEDURE', 'description': 'Maxillary fixed prosthesis according to all on four or all on six concept', 'armGroupLabels': ['all on four group', 'all on six group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35111', 'city': 'Al Mansurah', 'state': 'DK', 'country': 'Egypt', 'facility': 'Amr Saeed', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'researcher', 'investigatorFullName': 'Amr ELsaeed', 'investigatorAffiliation': 'Mansoura University'}}}}