Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:55 PM
Study NCT ID:
NCT07333235
Status:
COMPLETED
Last Update Posted:
2026-01-12
First Post:
2026-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone Level Evaluation Around Implants in All on Four Hybrid Restorations With Different Connections (Radiographic Evaluation)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-01', 'studyFirstSubmitDate': '2026-01-01', 'studyFirstSubmitQcDate': '2026-01-01', 'lastUpdatePostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'crestal bone loss around implants', 'timeFrame': '12 months', 'description': 'The DIGORA Optime intraoral sensor and a specially built acrylic template for each patient will be used to take intraoral radiographs with the standardized long cone paralleling technique to measure changes of crestal bone level around each implant. Periods of 0 (immediately after delivery of final prosthesis), 3, 6, and 9 months after delivery of final prosthesis for radiographic evaluation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['implant-supported prostheses', 'OT abutment', 'multi-unit abutment', 'crestal bone loss'], 'conditions': ['Bone Loss in Jaw']}, 'descriptionModule': {'briefSummary': 'this research aims to compare between using multiunit abutments and OT Equator abutments for constructing implant supported fixed mandibular prosthesis regarding the marginal bone height alteration around the implants through radiographic evaluation', 'detailedDescription': 'Patient selection:\n\nFourteen completely edentulous male patients free from any systemic diseases that would affect bone metabolism, had no history of recent administration of chemotherapy or radiotherapy and no history of para-functional habits will be selected from out-patients clinic.\n\nGrouping of patients:\n\nThe first group will include seven patients who will be planned to receive screw retained implant supported mandibular prosthesis with multiunit abutments.\n\nThe second group will include seven patients who will be planned to receive screw retained implant supported mandibular prosthesis with OT Equator abutments.\n\nPre-surgical protocol:\n\nFor each patient, upper and lower complete dentures will be constructed. Using dual CBCT scan protocol, stereolithographic surgical guide will be constructed according to virtual implant planning in the software.\n\nSurgical protocol:\n\nThe 3D surgical guide will be used to insert four implants in mandibular canines and mandibular first molar positions.\n\nFor the first group, multiunit abutments will be screwed to the four implants. For the second group, OT EQUATOR abutments will be screwed to the four implants.\n\nDenture conversion for temporization:\n\nTrans-mucosal abutments will be used to convert the denture to a temporary fixed implant supported restoration and will be screwed on multiunit abutments of the first group and on OT EQUATOR abutments for the second group.\n\nDelivery of final prosthesis:\n\nAfter three months of implant insertion, the final prosthesis will be constructed and then screwed to the multiunit abutments for the first group and to the OT Equator abutments for the second group.\n\nRadiographic Evaluation:\n\nThe DIGORA Optime intraoral sensor and a specially built acrylic template for each patient will be used to take intraoral radiographs with the standardized long cone paralleling technique to measure changes of crestal bone level around each implant. Periods of 0 (immediately after delivery of final prosthesis), 3, 6, and 9 months after delivery of final prosthesis for radiographic evaluation.\n\nStatistical analysis:\n\nBone loss measurements will be tabulated and statistically analyzed.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'genderBased': True, 'genderDescription': 'Male patients were only selected to avoid the effect of sex related variations as habits and physiology. Also, to avoid the effect of sex related hormonal changes which were reported to contribute to mucosal changes and osteoporosis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* completely edentulous patients\n* male patients\n* free from any systemic diseases\n* no history of recent administration of chemotherapy or radiotherapy\n* no history of para-functional habits\n\nExclusion Criteria:\n\n* female patients\n* diabetic patients and patients with bone metabolism diseases\n* history of recent administration of chemotherapy or radiotherapy\n* history of para-functional habits\n* Heavy smokers.\n* Heavy consumption of Alcohol'}, 'identificationModule': {'nctId': 'NCT07333235', 'briefTitle': 'Bone Level Evaluation Around Implants in All on Four Hybrid Restorations With Different Connections (Radiographic Evaluation)', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Bone Level Evaluation Around Implants in All on Four Hybrid Restorations With Different Connections (Radiographic Evaluation)', 'orgStudyIdInfo': {'id': 'FD-ERU-Rec 24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'multiunit abutments', 'description': 'multiunit abutments will be used to support the implant-supported prostheses', 'interventionNames': ['Other: different types of abutments (multiunit abutments OR OT EQUATOR abutments) will be screwed to the four implants to support the prosthesis']}, {'type': 'EXPERIMENTAL', 'label': 'OT EQUATOR abutments', 'description': 'OT EQUATOR abutments will be used to support the implant-supported prostheses', 'interventionNames': ['Other: different types of abutments (multiunit abutments OR OT EQUATOR abutments) will be screwed to the four implants to support the prosthesis']}], 'interventions': [{'name': 'different types of abutments (multiunit abutments OR OT EQUATOR abutments) will be screwed to the four implants to support the prosthesis', 'type': 'OTHER', 'description': 'for one group, multiunit abutments will be screwed to the four implants to support the prosthesis.\n\nfor the second group, OT EQUATOR abutments will be screwed to the four implants to support the prosthesis.', 'armGroupLabels': ['OT EQUATOR abutments', 'multiunit abutments']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11829', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Oral and Dental Medicine - Egyptian Russian University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Egyptian Russian University', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}