Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-26 @ 5:19 PM
Study NCT ID:
NCT00713206
Status:
COMPLETED
Last Update Posted:
2023-07-13
First Post:
2008-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Prospective Study of NanoTite Implants Placed Into Fresh Sinus-Lift Augmentation Sites (VSSL)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014076', 'term': 'Tooth Diseases'}], 'ancestors': [{'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015921', 'term': 'Dental Implants'}], 'ancestors': [{'id': 'D003764', 'term': 'Dental Materials'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D017266', 'term': 'Dental Prosthesis'}, {'id': 'D011476', 'term': 'Prosthodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cristina.matthews@biomet.com', 'phone': '5617766722', 'title': 'Clinical Research Manager', 'organization': 'Biomet 3i LLC'}, 'certainAgreement': {'otherDetails': 'PI shall furnish SPONSOR with a copy of any proposed publication thirty (30) days prior to submission for publication for review and comment. SPONSOR may request PI to delay publishing such proposed publication for a maximum of an additional sixty (60) days in order to protect the potential patentability of any invention described therein.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events are collected and reported from day 1 up to 3 years (end of the study)', 'description': "Adverse event data is collected by patient questioning and visual examination of patient's mouth during each study visit", 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Group', 'description': 'Dental implants placed simultaneously with graft augmentation material.', 'otherNumAtRisk': 65, 'otherNumAffected': 2, 'seriousNumAtRisk': 65, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Dental implants placed into graft augmentation material that has four months to heal.', 'otherNumAtRisk': 57, 'otherNumAffected': 1, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Mobility', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 65, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 57, 'numEvents': 57, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Implants Not Mobile (Not Failing) at End of 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}, {'units': 'dental implant', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': 'Dental implants placed simultaneously with graft augmentation material.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Dental implants placed into graft augmentation material that has four months to heal.'}], 'classes': [{'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'All surviving implants at the end of study (3 years)', 'unitOfMeasure': 'dental implant', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'dental implant', 'denomUnitsSelected': 'dental implant', 'populationDescription': 'dental implants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Crestal Bone Loss (Measured Value of Bone Level Around the Dental Implant)', 'timeFrame': '3 year', 'description': 'Average measured bone loss (change from baseline) for each implant placed at 3 years final time frame', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2024-07'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Group', 'description': 'Dental implants placed simultaneously with graft augmentation material.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Dental implants placed into graft augmentation material that has four months to heal.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '158', 'numSubjects': '65'}, {'groupId': 'FG001', 'numUnits': '140', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '152', 'numSubjects': '60'}, {'groupId': 'FG001', 'numUnits': '131', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '6', 'numSubjects': '5'}, {'groupId': 'FG001', 'numUnits': '9', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'dental implant', 'recruitmentDetails': 'Patients enrolled in the study according to inclusion/ exclusion criteria as described in the protocol. Patient enrollment began September 2006 and ended May 2008.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Group', 'description': 'Dental implants placed simultaneously with graft augmentation material.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Dental implants placed into graft augmentation material that has four months to heal.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Portugal', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-11', 'studyFirstSubmitDate': '2008-07-09', 'resultsFirstSubmitDate': '2013-08-06', 'studyFirstSubmitQcDate': '2008-07-10', 'lastUpdatePostDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-08-06', 'studyFirstPostDateStruct': {'date': '2008-07-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Crestal Bone Loss (Measured Value of Bone Level Around the Dental Implant)', 'timeFrame': '3 year', 'description': 'Average measured bone loss (change from baseline) for each implant placed at 3 years final time frame'}], 'primaryOutcomes': [{'measure': 'Implants Not Mobile (Not Failing) at End of 3 Years', 'timeFrame': '3 years', 'description': 'All surviving implants at the end of study (3 years)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dental implants, maxilla, sinus lift, augmentation'], 'conditions': ['Tooth Disease', 'Partial Edentulism']}, 'descriptionModule': {'briefSummary': 'This prospective, randomized-controlled, clinical study evaluates the ability of the NanoTite implant system to achieve integration and provide long-term support of a prosthesis when placed immediately in fresh sinus augmentation material. Control cases will be those where the sinus augmentation material is allowed four months of healing prior to NanoTite implant placement. In addition to implant performance, radiographic evidence of crestal bone regressive modeling will be used to evaluate differences between test and control cases.\n\nStudy (null) hypothesis: The implants placed into sinus augmentation sites at the time of grafting will have the same integration success and maintenance of integration as for the implants placed after four months of graft healing.', 'detailedDescription': 'This will be a prospective, randomized-controlled, longitudinal study in which qualified patients with partial edentulism and thin maxillary ridges will have as part of their treatment at least one sinus ridge augmentation procedure and have their edentulism restored with an implant-supported short-span or long-span fixed bridge. Each patient may have up to two cases included in the study should they need bilateral sinus augmentation using unilateral bridge restorations on either side.\n\nEach patient (or side if a bilateral case) will be randomly assigned to one of two groups: Treatment Group 1 (test) cases will have implants placed into the sinus cavity during the graft augmentation procedure. Treatment Group 2 (control) will have a sinus lift augmentation and implant placement into this area will take place after four months of graft healing. For both groups the implants will be submerged and allowed four months of healing before second stage surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of either sex and any race greater than 18 years of age\n* Patients for whom a decision has already been made to augment one or both maxillary sinuses for the purpose of placing dental implants in a maxillary ridge no less than 3 mm high and no greater than 5 mm in height\n* Patients must be physically able to tolerate conventional surgical and restorative procedures.\n* Patients must agree to be evaluated for each study visit, especially the yearly follow-up visit\n\nExclusion Criteria:\n\n* Patients with active infection or severe inflammation in the areas intended for implant placement.\n* Patients with a \\>10 cigarettes per day smoking habit.\n* Patients with uncontrolled diabetes mellitus.\n* Treatment with therapeutic radiation to the head within the past 12 months.\n* Patients who are pregnant at the screening visit.\n* Patients with evidence of severe para-functional habits such as bruxing or clenching.'}, 'identificationModule': {'nctId': 'NCT00713206', 'briefTitle': 'Prospective Study of NanoTite Implants Placed Into Fresh Sinus-Lift Augmentation Sites (VSSL)', 'organization': {'class': 'INDUSTRY', 'fullName': 'ZimVie'}, 'officialTitle': 'A Prospective, Randomized-Controlled, Multicenter Study of NanoTite Implants Placed Into Fresh Sinus Lift Augmentation Sites', 'orgStudyIdInfo': {'id': '2604'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dental implant (Osseotite)', 'description': 'Dental implants placed simultaneously with graft augmentation material.', 'interventionNames': ['Device: Dental Implant (Osseotite)']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Dental implants placed into graft augmentation material that has four months to heal.'}], 'interventions': [{'name': 'Dental Implant (Osseotite)', 'type': 'DEVICE', 'otherNames': ['Osseotite'], 'description': 'Root form titanium dental implant', 'armGroupLabels': ['Dental implant (Osseotite)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chieti', 'country': 'Italy', 'facility': 'Università "G. d\' Annunzio" Chieti-Pescara', 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}], 'overallOfficials': [{'name': 'Sergio Caputi, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director del Dipartimento di Scienze Odontostomatologiche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ZimVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}