Comparing two types of membranes for bone and tissue healing in dental implants

Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason® Membrane in Simultaneous Implantations. A Prospective, Randomized Controlled Trial.

This study is testing which type of membrane works better for helping people with dental implants heal their bone and soft tissue.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 65 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Datum Dental LTD (Industry-sponsored)
• Locations: 3 sites (Jerusalem and 2 other locations)
• Trial ID: NCT05584566 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective randomized controlled parallel trial aimed at evaluating bone formation and soft tissue healing in patients with ridge deficiencies undergoing simultaneous dental implant placement. It compares the effectiveness of OSSIX® Breeze, a sugar cross-linked pericardium membrane, against Jason®, a native pericardium membrane, over periods of 4 and 8 months. Eligible participants include adults with specific oral health criteria who require guided bone regeneration treatment for implant placement. The study will assess outcomes related to bone and tissue healing to determine the superior membrane option.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and above with buccal bone defects requiring 1-3 dental implants and who can maintain good oral hygiene.

Not a fit: Patients with severe health conditions (ASA III or IV), autoimmune diseases, or sensitivities to porcine-derived materials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve dental implant outcomes by identifying the most effective membrane for bone and tissue healing.

How similar studies have performed: While this approach is not widely tested, similar studies comparing membrane types in dental procedures have shown promising results.

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.

Where this trial is running

Jerusalem and 2 other locations

• Hadassah Medical Center — Jerusalem, Israel (Recruiting)
• Rabin Medical Center — Petah Tikva, Israel (Recruiting)
• University of Birmingham — Birmingham, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Gavriel Chaushu, prof

Conditions Ridge Augmentation