Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-03-06 @ 10:09 PM
Study NCT ID:
NCT02186912
Status:
TERMINATED
Last Update Posted:
2016-04-05
First Post:
2014-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
All-On-4® Treatment Concept
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009066', 'term': 'Mouth, Edentulous'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'whyStopped': 'The study stopped as the performance of the study showed insufficient patient recruitment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-04', 'studyFirstSubmitDate': '2014-07-08', 'studyFirstSubmitQcDate': '2014-07-08', 'lastUpdatePostDateStruct': {'date': '2016-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of Life', 'timeFrame': 'yearly up to 5 years'}], 'primaryOutcomes': [{'measure': 'bone level change around tilted and straight implants', 'timeFrame': 'yearly up to 5 years'}], 'secondaryOutcomes': [{'measure': 'cumulative survival rate (CSR)', 'timeFrame': 'yearly up to 5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['edentulous', 'Nobel Active', 'Nobel Procera', 'IBO', 'CAD/CAM'], 'conditions': ['Edentulous']}, 'descriptionModule': {'briefSummary': 'Indication : edentulous patients To evaluate and compare the marginal bone level change around tilted and straight NobelActive implants placed in healed sites with All-on-4-treatment concept after immediate function supporting NobelProcera Implant Bridge (fixed) in the mandible and maxilla.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "The subject is at least 18 years of age (or age of consent) and has passed secession of growth\n\nObtained informed consent from the subject\n\nEdentulous mandible or maxilla providing sufficient bone whereas a fixed NobelProceraTM Implant bridge on four (4) implants is regarded as an appropriate treatment solution\n\nThe subject has an osseous architecture enough to receive four implants and a sufficient amount of bone for placing in healed sites implants with a length of at least 8 mm\n\nThe implant site is free from infection and extraction remnants Implants will be placed in healed sites.\n\nGood gingival / periodontal / peri-apical status of opposing teeth/implants\n\nThe subject fulfills the prerequisite that a harmonic, stable occlusal relationship can be achieved with opposing natural teeth resp. fixed or removable opposing dentition (tooth or implant based\n\nThe subjects as well as the implant site(s) fulfill the criteria for immediate loading.\n\nThe subject is in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems The subject is available for the 5-year term of the investigation\n\nExclusion Criteria:\n\nThe subject is not able to give her/his informed consent of participating\n\nHealth conditions, which do not permit the surgical (including anesthesia) or restorative procedure\n\nReason to believe that the treatment might have a negative effect on the subject's overall situation (psychiatric problems), as noted in subject records or in subject history Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous irradiation in the head/neck area\n\nAlcohol or drug abuse as noted in subject records or in subject history Smoking of \\>10 cigarettes/day\n\nUncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake\n\nPathologic occlusion, e.g. severe bruxism or other destructive habits\n\nLack of opposing dentition or unstable occlusion\n\nOngoing infections, endodontic or periodontal problems in opposing teeth or implants\n\nSubject shows an unacceptable oral hygiene\n\nSubject has allergic or adverse reactions to the restorative material.\n\nBone augmentation of more than 3mm vertical height performed less than 6 months prior to planned implant placement.\n\nBis-phosphonate therapy\n\nImplant insertion torque is \\<35 Ncm or \\>70 Ncm"}, 'identificationModule': {'nctId': 'NCT02186912', 'briefTitle': 'All-On-4® Treatment Concept', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nobel Biocare'}, 'officialTitle': 'A Clinical Evaluation of All-On-4® Treatment Concept in the Mandible or Maxilla on 4 NobelActive®Implants With a Fixed NobelProcera® Implant Bridge', 'orgStudyIdInfo': {'id': 'T-185'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mandible', 'description': 'Nobel Active Nobel Procera IBO', 'interventionNames': ['Device: Nobel Active, Nobel Procera IBO']}, {'type': 'EXPERIMENTAL', 'label': 'maxilla', 'description': 'Nobel Active Nobel Procera IBO', 'interventionNames': ['Device: Nobel Active, Nobel Procera IBO']}], 'interventions': [{'name': 'Nobel Active, Nobel Procera IBO', 'type': 'DEVICE', 'otherNames': ['Nobel Active implants', 'Implant bar'], 'armGroupLabels': ['mandible', 'maxilla']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55131', 'city': 'Mainz', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Universitätsmedizin Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nobel Biocare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}