Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason®

NCT05584566 | Recruiting DMC

• 1 other identifier: DD-OG-01
• Study Type: interventional
• Target: 65
• Locations: 2 countries
• Sites: 3

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®).

Conditions

Ridge Augmentation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

OSSIX Breeze

EXPERIMENTAL

Device: OSSIX Breeze

Jason membrane

ACTIVE COMPARATOR

Device: Jason membrane

Interventions

OSSIX Breeze DEVICE

barrier membrane

OSSIX Breeze

Jason membrane DEVICE

barrier membrane

Jason membrane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, age 18 and above.
• General good health (ASA 1 and ASA 2).
• Adults with buccal bone defect, who are in need of implant placement, and going through a guided bone regeneration treatment.
• Patient needs 1-3 implants.
• Good oral hygiene (full mouth plaque index \<25%).
• Adequate control of inflammation (full mouth bleeding on probing \<25%).
• Patient is willing to sign an informed consent and participate in the clinical study.
• Patient is able to understand and comply with the study related procedures, such as exercising good oral hygiene and attending all follow-up examinations.

You may not qualify if:

• Physical status ASA III or ASA IV.
• General contraindications for dental and/or surgical treatments.
• Inflammatory and autoimmune disease of the oral cavity.
• Patients with known collagen hypersensitivity.
• Patients with sensitivity to porcine-derived materials.
• Patients suffering from autoimmune diseases and connective tissue diseases, such as: systemic lupus erythematosus, dermatomyositis, etc.
• Acute infection in the oral cavity or acute inflammation at the implantation site.
• General diseases, where measures of stomatology, maxillo-facial surgery, implantology, periodontology, endodontology or other measures of oral surgery are contraindicated.
• Disease of oral mucosa.
• Uncontrolled periodontal disease
• Concurrent or previous radiotherapy of head area.
• Concurrent or previous immunosuppressant, bisphosphonate, or high-dose corticosteroid therapy.
• Smoking (over 10 cigarettes a day).
• Pregnant or lactating women.
• Women of childbearing potential, who are not using a highly effective method of birth control.

Sponsors & Collaborators

• Datum Dental LTD: lead

Study Sites (3)

Hadassah Medical Center

Jerusalem, Israel

RECRUITING

Rabin Medical Center

Petah Tikva, 4928451, Israel

RECRUITING

University of Birmingham

Birmingham, United Kingdom

RECRUITING

Central Study Contacts

Gavriel Chaushu, prof

CONTACT

+97239377207; GavrielCe@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 18, 2022
• Study Start: December 1, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

IL (2); GB (1)