NCT05584566RecruitingNot Applicable
Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason® Membrane in Simultaneous Implantations. A Prospective, Randomized Controlled Trial.
Datum Dental LTD4 sites in 2 countries65 target enrollmentStarted: December 1, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 65
- Locations
- 4
- Primary Endpoint
- increase in bone gain
Study Overview
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®).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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.
Outcomes
Primary Outcomes
increase in bone gain
Time Frame: 4 months
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (4)
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