Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason®

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

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®).

Study Overview

• Status: Recruiting
• Conditions: Ridge Augmentation
• Intervention / Treatment: Device: OSSIX Breeze; Device: Jason membrane

• Study Type: Interventional
• Enrollment (Anticipated): 65
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Gavriel Chaushu, prof; Phone Number: +97239377207; Email: GavrielCe@clalit.org.il

Study Locations

• Israel
  • Be'er Sheva, Israel
    • Recruiting
    • SOROKA Medical Center
    • Contact: Anatoly Ilgayev, Dr; Email: natanil@clalit.org.il
  • Petah Tikva, Israel, 4928451
    • Recruiting
    • Rabin Medical Center
    • Contact: Gabi Chaushu, prof; Phone Number: 0524685734; Email: GavrielCe@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OSSIX Breeze	Device: OSSIX Breeze; barrier membrane
Active Comparator: Jason membrane	Device: Jason membrane; barrier membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
increase in bone gain	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	4 months

Collaborators and Investigators

• Sponsor: Datum Dental LTD

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 26, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: DD-OG-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No