Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
Study NCT ID:
NCT05584566
Status:
RECRUITING
Last Update Posted:
2024-10-16
First Post:
2022-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-14', 'studyFirstSubmitDate': '2022-10-11', 'studyFirstSubmitQcDate': '2022-10-13', 'lastUpdatePostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'increase in bone gain', 'timeFrame': '4 months', 'description': 'increase in bone gain (vertical and horizontal) in mm, 4 months after the implant placement in the augmented site. the measurment will be done according to radiographic images'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ridge Augmentation']}, 'descriptionModule': {'briefSummary': 'This is a prospective randomized controlled parallel trial. The aim of this study is to evaluate bone formation and soft tissue healing after 4 and 8 months in patients with ridge deficiencies in simultaneous implantation approach. The trial will compare a (sugar cross linked) - SCL pericardium membrane OSSIX® Breeze vs native pericardium membrane (Jason®).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males and females, age 18 and above.\n2. General good health (ASA 1 and ASA 2).\n3. Adults with buccal bone defect, who are in need of implant placement, and going through a guided bone regeneration treatment.\n4. Patient needs 1-3 implants.\n5. Good oral hygiene (full mouth plaque index \\<25%).\n6. Adequate control of inflammation (full mouth bleeding on probing \\<25%).\n7. Patient is willing to sign an informed consent and participate in the clinical study.\n\n10 8. Patient is able to understand and comply with the study related procedures, such as exercising good oral hygiene and attending all follow-up examinations.\n\nExclusion Criteria:\n\n1. Physical status ASA III or ASA IV.\n2. General contraindications for dental and/or surgical treatments.\n3. Inflammatory and autoimmune disease of the oral cavity.\n4. Patients with known collagen hypersensitivity.\n5. Patients with sensitivity to porcine-derived materials.\n6. Patients suffering from autoimmune diseases and connective tissue diseases, such as: systemic lupus erythematosus, dermatomyositis, etc.\n7. Acute infection in the oral cavity or acute inflammation at the implantation site.\n8. General diseases, where measures of stomatology, maxillo-facial surgery, implantology, periodontology, endodontology or other measures of oral surgery are contraindicated.\n9. Disease of oral mucosa.\n10. Uncontrolled periodontal disease\n11. Concurrent or previous radiotherapy of head area.\n12. Concurrent or previous immunosuppressant, bisphosphonate, or high-dose corticosteroid therapy.\n13. Smoking (over 10 cigarettes a day).\n14. Pregnant or lactating women.\n15. Women of childbearing potential, who are not using a highly effective method of birth control.\n16. Participation in another investigational device, drug, or biologics study within the last 24 weeks prior to study entry.'}, 'identificationModule': {'nctId': 'NCT05584566', 'briefTitle': 'Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason®', 'organization': {'class': 'INDUSTRY', 'fullName': 'Datum Dental LTD'}, 'officialTitle': 'Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason® Membrane in Simultaneous Implantations. A Prospective, Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'DD-OG-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OSSIX Breeze', 'interventionNames': ['Device: OSSIX Breeze']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Jason membrane', 'interventionNames': ['Device: Jason membrane']}], 'interventions': [{'name': 'OSSIX Breeze', 'type': 'DEVICE', 'description': 'barrier membrane', 'armGroupLabels': ['OSSIX Breeze']}, {'name': 'Jason membrane', 'type': 'DEVICE', 'description': 'barrier membrane', 'armGroupLabels': ['Jason membrane']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Asaf Wilenski, Prof', 'role': 'CONTACT'}], 'facility': 'Hadassah Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '4928451', 'city': 'Petah Tikva', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Gabi Chaushu, prof', 'role': 'CONTACT', 'email': 'GavrielCe@clalit.org.il', 'phone': '0524685734'}], 'facility': 'Rabin Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Birmingham', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Thomas Dietrich, Prof', 'role': 'CONTACT'}], 'facility': 'University of Birmingham', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}], 'centralContacts': [{'name': 'Gavriel Chaushu, prof', 'role': 'CONTACT', 'email': 'GavrielCe@clalit.org.il', 'phone': '+97239377207'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Datum Dental LTD', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}