Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-01-26 @ 2:25 PM
Study NCT ID:
NCT00639860
Status:
COMPLETED
Last Update Posted:
2016-03-31
First Post:
2008-03-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of OSSIX-Plus Resorbable Collagen Membranes for Alveolar Ridge Preservation Following Exodontia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016301', 'term': 'Alveolar Bone Loss'}], 'ancestors': [{'id': 'D001862', 'term': 'Bone Resorption'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wgiannob@umich.edu', 'phone': '734-763-2105', 'title': 'Dr. William Giannobile, Chair Department of Periodontics and Oral Medicine', 'organization': 'University of Michigan School of Dentistry'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placing OSSIX-Plus in Extraction Site', 'description': 'Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.\n\nOSSIX-Plus: resorbable collagen membrane', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Bone Gain or Loss in Millimeters (Buccopalatal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placing OSSIX-Plus in Extraction Site', 'description': 'Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.\n\nOSSIX-Plus: resorbable collagen membrane'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to 12 weeks', 'description': 'Socket width (buccopalatal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.', 'unitOfMeasure': 'mm', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Bone Gain or Loss in Millimeters (Mesiodistal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placing OSSIX-Plus in Extraction Site', 'description': 'Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.\n\nOSSIX-Plus: resorbable collagen membrane'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to 12 weeks', 'description': 'Socket width (mesiodistal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.', 'unitOfMeasure': 'mm', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Bone Gain or Loss in Millimeters (Stent to Apex)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placing OSSIX-Plus in Extraction Site', 'description': 'Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.\n\nOSSIX-Plus: resorbable collagen membrane'}], 'classes': [{'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '20.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to 12 weeks', 'description': 'Stent to apex of socket measured by a calibrated examiner using a University of North Carolina (UNC) probe.', 'unitOfMeasure': 'mm', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Radiographic Bone Changes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placing OSSIX-Plus in Extraction Site', 'description': 'Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.\n\nOSSIX-Plus: resorbable collagen membrane'}], 'classes': [{'categories': [{'measurements': [{'value': '86.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to 12 weeks', 'description': 'Radiographic measures were accomplished utilizing a real-time subtraction program, Computer Assisted Radiographic Evaluation (C.A.R.E.).', 'unitOfMeasure': 'percentage of bone fill', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'New Bone Formation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Placing OSSIX-Plus in Extraction Site', 'description': 'Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.\n\nOSSIX-Plus: resorbable collagen membrane'}], 'classes': [{'categories': [{'measurements': [{'value': '46.09', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to 12 weeks', 'description': 'Percentage of new bone formation of the alveolar bone core biopsies.', 'unitOfMeasure': 'percentage of vital bone', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placing OSSIX-Plus in Extraction Site', 'description': 'Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.\n\nOSSIX-Plus: resorbable collagen membrane'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Placing OSSIX-Plus in Extraction Site', 'description': 'Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.\n\nOSSIX-Plus: resorbable collagen membrane'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '47.7', 'groupId': 'BG000', 'lowerLimit': '25', 'upperLimit': '64'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Socket width (buccopalatal)', 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'groupId': 'BG000', 'lowerLimit': '7.0', 'upperLimit': '10.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm', 'dispersionType': 'FULL_RANGE'}, {'title': 'Socket width (meiodistal)', 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'groupId': 'BG000', 'lowerLimit': '4.0', 'upperLimit': '8.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm', 'dispersionType': 'FULL_RANGE'}, {'title': 'Stent to buccal plate', 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'BG000', 'lowerLimit': '4.0', 'upperLimit': '8.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm', 'dispersionType': 'FULL_RANGE'}, {'title': 'Stent to mesial osseous crest', 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'BG000', 'lowerLimit': '2.0', 'upperLimit': '6.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm', 'dispersionType': 'FULL_RANGE'}, {'title': 'Stent to distal osseous crest', 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'BG000', 'lowerLimit': '2.0', 'upperLimit': '6.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm', 'dispersionType': 'FULL_RANGE'}, {'title': 'Stent to midosseous crest', 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'groupId': 'BG000', 'lowerLimit': '3.0', 'upperLimit': '7.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm', 'dispersionType': 'FULL_RANGE'}, {'title': 'Stent to apex of socket', 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'groupId': 'BG000', 'lowerLimit': '11.0', 'upperLimit': '20.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mm', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-01', 'studyFirstSubmitDate': '2008-03-14', 'resultsFirstSubmitDate': '2015-12-11', 'studyFirstSubmitQcDate': '2008-03-14', 'lastUpdatePostDateStruct': {'date': '2016-03-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-01', 'studyFirstPostDateStruct': {'date': '2008-03-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Bone Gain or Loss in Millimeters (Buccopalatal)', 'timeFrame': 'From Baseline to 12 weeks', 'description': 'Socket width (buccopalatal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.'}, {'measure': 'Change in Bone Gain or Loss in Millimeters (Mesiodistal)', 'timeFrame': 'From Baseline to 12 weeks', 'description': 'Socket width (mesiodistal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.'}, {'measure': 'Change in Bone Gain or Loss in Millimeters (Stent to Apex)', 'timeFrame': 'From Baseline to 12 weeks', 'description': 'Stent to apex of socket measured by a calibrated examiner using a University of North Carolina (UNC) probe.'}, {'measure': 'Radiographic Bone Changes', 'timeFrame': 'From Baseline to 12 weeks', 'description': 'Radiographic measures were accomplished utilizing a real-time subtraction program, Computer Assisted Radiographic Evaluation (C.A.R.E.).'}, {'measure': 'New Bone Formation', 'timeFrame': 'From Baseline to 12 weeks', 'description': 'Percentage of new bone formation of the alveolar bone core biopsies.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['extraction', 'implant', 'alveolar ridge preservation'], 'conditions': ['Alveolar Bone Loss', 'Loss of Teeth Due to Extraction', 'Edentulous Alveolar Ridge']}, 'referencesModule': {'references': [{'pmid': '21845241', 'type': 'RESULT', 'citation': 'Neiva R, Pagni G, Duarte F, Park CH, Yi E, Holman LA, Giannobile WV. Analysis of tissue neogenesis in extraction sockets treated with guided bone regeneration: clinical, histologic, and micro-CT results. Int J Periodontics Restorative Dent. 2011 Sep-Oct;31(5):457-69.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate clinically, histologically and radiographically the healing of extraction sockets covered with a resorbable collagen membrane (OSSIX-Plus) 12 weeks following exodontia.', 'detailedDescription': 'Reduction in alveolar ridge height and width may prohibit optimal implant placement, and often compromises the esthetic and functional result. Alveolar ridge preservation has been evaluated in many studies. A variety of bone grafting materials and barrier membranes have been studied for their ability to enhance bone formation in damaged alveolar ridges, and to evaluate their bone healing and bone-forming capacity in extraction sockets. However, the newly developed resorbable collagen membrane OSSIX-Plus has not been evaluated for this purpose. This study is designed to test the ability of OSSIX-Plus (OraPharma Inc., Warminster, Pennsylvania) in promoting optimal bone healing following exodontia. We hypothesize that use of OSSIX-Plus will result in preservation of the height, width and density of the residual alveolar ridge following tooth extraction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systemically healthy subjects with 1 maxillary premolar tooth requiring extraction\n* Residual extraction sockets must have \\< 80% bone loss in all dimensions (3 or 4-walled bony defects)\n* Nonsmokers (individuals who quit smoking at least 6 months prior to the study will be allowed to participate)\n* Subjects willing and able to comply with all study-related procedures including maintenance of good oral hygiene and compliance with re-evaluation appointments\n* Subjects who read, understand and are willing to sign an informed consent statement\n\nExclusion Criteria:\n\n* Inadequate zone of keratinized gingiva (KG) or alveolar mucosa to obtain primary wound closure of the surgical site\n* Presence of acute infections at the time of tooth extraction\n* Clinically significant or unstable (as defined by the investigators) systemic diseases affecting bone or soft tissue growth or other renal, hepatic, cardiac, endocrine, hematological, autoimmune or acute infectious diseases that makes interpretation of the data more difficult\n* History of head \\& neck radiation therapy\n* Subjects taking steroids, tetracycline or tetracycline analogs, bone therapeutic levels of fluorides, biphosphonatesm, medications affecting bone turnover, antibiotics for \\> 7 days or any investigational drug\n* Patients who are or become pregnant during the length of the study\n* Sites in which one or both adjacent teeth are missing'}, 'identificationModule': {'nctId': 'NCT00639860', 'acronym': 'OSSIX', 'briefTitle': 'Evaluation of OSSIX-Plus Resorbable Collagen Membranes for Alveolar Ridge Preservation Following Exodontia', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Clinical and Histological Evaluation of OSSIX-Plus Resorbable Collagen Membranes for Alveolar Ridge Preservation Following Exodontia', 'orgStudyIdInfo': {'id': 'HUM00016574'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placing OSSIX-Plus in Extraction Site', 'description': 'Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.', 'interventionNames': ['Device: OSSIX-Plus']}], 'interventions': [{'name': 'OSSIX-Plus', 'type': 'DEVICE', 'description': 'resorbable collagen membrane', 'armGroupLabels': ['Placing OSSIX-Plus in Extraction Site']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Center for Oral Health Research', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'William V Giannobile, DDS, DMedSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'William Giannobile', 'class': 'OTHER'}, 'collaborators': [{'name': 'Johnson & Johnson', 'class': 'INDUSTRY'}, {'name': 'OraPharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'William Giannobile, D.D.S., D.Med.Sc.', 'investigatorFullName': 'William Giannobile', 'investigatorAffiliation': 'University of Michigan'}}}}