Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason®
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OSSIX Breeze, Jason membrane.
- Who it may be relevant to
- Registry conditions: Ridge Augmentation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason® Membrane in Simultaneous Implantations. A Prospective, Randomized Controlled Trial.
Overview
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®).
Interventions
- Device OSSIX Breeze
barrier membrane - Device Jason membrane
barrier membrane
Primary outcome measures
- increase in bone gain [Time frame: 4 months]
Eligibility criteria
Inclusion criteria
- 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.
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
- 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.
- Participation in another investigational device, drug, or biologics study within the last 24 weeks prior to study entry.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Israel · 2 centers
- Hadassah Medical Center — Jerusalem
- Rabin Medical Center — Petah Tikva
United Kingdom · 1 center
- University of Birmingham — Birmingham
Identifiers
NCT: NCT05584566 · DD-OG-01