Phase
Condition
N/ATreatment
OSSIX Breeze
Jason membrane
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 goingthrough 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 clinicalstudy.
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
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 arecontraindicated.
Disease of oral mucosa.
Uncontrolled periodontal disease
Concurrent or previous radiotherapy of head area.
Concurrent or previous immunosuppressant, bisphosphonate, or high-dosecorticosteroid therapy.
Smoking (over 10 cigarettes a day).
Pregnant or lactating women.
Women of childbearing potential, who are not using a highly effective method ofbirth control.
Participation in another investigational device, drug, or biologics study within thelast 24 weeks prior to study entry.
Study Design
Connect with a study center
Soroka Medical Center
Be'er Sheva,
IsraelSite Not Available
Hadassah Medical Center
Jerusalem,
IsraelActive - Recruiting
Rabin Medical Center
Petah Tikva, 4928451
IsraelActive - Recruiting
University of Birmingham
Birmingham,
United KingdomActive - Recruiting
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