NCT05584566 Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason®
| NCT ID | NCT05584566 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Datum Dental LTD |
| Condition | Ridge Augmentation |
| Study Type | INTERVENTIONAL |
| Enrollment | 65 participants |
| Start Date | 2022-12-01 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 65 participants in total. It began in 2022-12-01 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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®).
Eligibility Criteria
Inclusion Criteria: 1. Males and females, age 18 and above. 2. General good health (ASA 1 and ASA 2). 3. Adults with buccal bone defect, who are in need of implant placement, and going through a guided bone regeneration treatment. 4. Patient needs 1-3 implants. 5. Good oral hygiene (full mouth plaque index \<25%). 6. Adequate control of inflammation (full mouth bleeding on probing \<25%). 7. Patient is willing to sign an informed consent and participate in the clinical study. 10 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. Exclusion Criteria: 1. Physical status ASA III or ASA IV. 2. General contraindications for dental and/or surgical treatments. 3. Inflammatory and autoimmune disease of the oral cavity. 4. Patients with known collagen hypersensitivity. 5. Patients with sensitivity to porcine-derived materials. 6. Patients suffering from autoimmune diseases and connective tissue diseases, such as: systemic lupus erythematosus, dermatomyositis, etc. 7. Acute infection in the oral cavity or acute inflammation at the implantation site. 8. General diseases, where measures of stomatology, maxillo-facial surgery, implantology, periodontology, endodontology or other measures of oral surgery are contraindicated. 9. Disease of oral mucosa. 10. Uncontrolled periodontal disease 11. Concurrent or previous radiotherapy of head area. 12. Concurrent or previous immunosuppressant, bisphosphonate, or high-dose corticosteroid therapy. 13. Smoking (over 10 cigarettes a day). 14. Pregnant or lactating women. 15. Women of childbearing potential, who are not using a highly effective method of birth control. 16. Participation in another investigational device, drug, or biologics study within the last 24 weeks prior to study entry.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05584566 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ridge Augmentation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05584566 currently recruiting?
Yes, NCT05584566 is actively recruiting participants. Contact the research team at GavrielCe@clalit.org.il for enrollment information.
Where is the NCT05584566 trial being conducted?
This trial is being conducted at Jerusalem, Israel, Petah Tikva, Israel, Birmingham, United Kingdom.
Who is sponsoring the NCT05584566 clinical trial?
NCT05584566 is sponsored by Datum Dental LTD. The trial plans to enroll 65 participants.