Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT06187805
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-01-05
First Post:
2023-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrospective Case Series - OSSIX Volumax Collagen Xenograft Scaffolding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-02-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-03', 'studyFirstSubmitDate': '2023-12-17', 'studyFirstSubmitQcDate': '2023-12-17', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in crestal bone height', 'timeFrame': '4 months to 57 months', 'description': 'Measured radiographically and by cone beam computed tomography at follow up'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Dental Implants']}, 'descriptionModule': {'briefSummary': 'This study is designed as a retrospective, single center study. Up to 15 participants who had a transcrestal sinus elevation and implant placement using autogenous bone supporting an OSSIX Volumax collagen xenograft scaffolding will be enrolled. The study will include data collection from medical records and data collected at a follow up visit between January 2019 and March 2023.', 'detailedDescription': 'The purpose of this study is to evaluate the outcome of transcrestal sinus elevation using autogenous bone supporting an OSSIX Volumax collagen scaffolding. Data to be collected includes demographics, past medical history including autoimmune diseases and connective tissue diseases, smoking history and known allergies. Implant data will be collected and change in crestal bone height will be measured radiographically and cone beam computed tomography at follow up. The protocol will include both single-staged and two-staged procedures. Adverse events will be collected and reported.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Up to 15 participants who meet the I/E will have data retrospectively reviewed and will include follow up data.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Transcrestal sinus lift planned\n2. Implant therapy planned\n3. Crestal bone height \\< or equal to 6mm\n4. Missing tooth or teeth for function\n5. Nonsmoker -\n\nExclusion Criteria:\n\n1. Patients with known collagen hypersensitivity\n2. Patients with sensitivity to porcine-derived materials\n3. Patients suffering from autoimmune diseases and connective tissue diseases, such as lupus erythematosus, dermatomyositis, etc.\n4. Pregnant or planning to become pregnant (verbal confirmation)'}, 'identificationModule': {'nctId': 'NCT06187805', 'briefTitle': 'Retrospective Case Series - OSSIX Volumax Collagen Xenograft Scaffolding', 'organization': {'class': 'OTHER', 'fullName': 'Old Orchard Periodontics and Implant Dentistry LTD'}, 'officialTitle': 'Retrospective Case Series Evaluating the Outcome of Transcrestal Sinus Elevation Using Autogenous Bone Supporting an OSSIX Volumax Collagen Xenograft Scaffolding', 'orgStudyIdInfo': {'id': 'Ver 01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Up to 15 patients', 'description': 'Patients who have had a transcrestal elevation using autogenous bone supporting an OSSIX Volumax collagen scaffolding.', 'interventionNames': ['Device: OSSIX Volumax']}], 'interventions': [{'name': 'OSSIX Volumax', 'type': 'DEVICE', 'description': 'OSSIX Volumax is used in combination with autogenous bone collected during preparation of the implant osteotomy.', 'armGroupLabels': ['Up to 15 patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60077', 'city': 'Skokie', 'state': 'Illinois', 'country': 'United States', 'facility': 'Old Orchard Periodontics and Implant Dentistry', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Old Orchard Periodontics and Implant Dentistry LTD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}