The Osgide membrane is a biodegradable barrier membrane for use in Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) procedures. In these procedures, the Osgide membrane can be used as a resorbable membrane for the containment of bone grafts in bone repair procedures during treatment of periodontal bone defects (GTR) and for bone augmentation procedures (GBR).
Osgide is a highly purified membrane produced from porcine collagen using controlled and standardized manufacturing processes. Starting materials for the production of Osgide are harvested in EU certified facilities under strict veterinary controls from animals declared fit for human consumption. Osgide is packaged in double blisters and sterilized by ethylene oxide gas treatment.
Properties
The Osgide membrane is composed of a network of highly purified porcine collagen fibers intermingled with highly purified porcine elastin fibers. The membrane is designed to protect the bone defect space in order to establish an environment favourable for bone regeneration by preventing the migration of undesired cells from the surrounding soft tissue and allowing the ingrowth of osteogenic cells. The fiber network provides the Osgide membrane with mechanical strength and prevents the migration of bone graft material.
The Osgide membrane is biodegradable and a second surgical procedure to remove the membrane is not needed. The excellent biocompatibility of the Osgide membrane is due to the utilization of effective purification and processing methods during manufacturing. Experimental studies have shown that the Osgide membrane can be considered safe regarding potential viral transmission.
Minor variations in thickness and a slightly irregular collagen structure can be occasionally seen with dry Osgide membranes. This is due to the natural origin of the membrane and does not influence its clinical performance. Osgide membranes are hydrophilic and retain their structural integrity also in the wet state. Application of the Osgide membrane should involve the use of space-maintaining bone graft material, whenever possible.
Indications
The Osgide membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier membrane in the fields of:
Implantology: To support the process of bone augmentation when the existing amount of bone is not sufficient for long-term stable dental implant anchoring. Augmentation around implants placed in immediate/delayed extraction sockets, localized ridge augmentation, alveolar ridge preservation/reconstruction, osseous fill around implants in peri-implantitis bone defects (only in cases where satisfactory debridement and implant surface disinfection can be achieved), as a cover over the window in lateral window sinus elevation procedures, and as a protection of Schneider’s membrane.
Periodontology: To preserve existing teeth that have lost their secure anchorage in the bone because of intra-bony defects around teeth as a result of periodontal disease (whenever possible only in combination with space maintaining material). For treatment of recession defects, together with coronally positioned flap. In furcation defects in multi-rooted teeth.
Limitations of Use
Contraindications:
The use of the Osgide membrane without space maintaining bone grafting material is not indicated.
Osgide should not be used in infected areas. An active infection of the implant site may lead to an increased biodegradation of the Osgide membrane which may lead to an early loss of its barrier function.
Adverse reactions during the use of collagen membranes in GBR/GTR procedures have not been observed. However, allergic reactions may not be totally excluded since the Osgide membrane is a collagen product. The use of Osgide in patients with known sensitivity to porcine materials is not recommended.
Undesirable side effects:
In case of soft tissue wound dehiscence, an increase in biodegradation of Osgide may occur, which could result in an earlier loss of the barrier function.
Other possible side effects are not specifically related to the Osgide membrane itself but may occur with any surgery, like infection, wound swelling, bleeding, local inflammation, bone loss, or pain.
Precautions:
In patients with constrained healing capacity (e.g. due to metabolic disorders, cancer treatments, heavy smoking) Osgide should be used with special caution and enhanced postoperative care.
Clinical data on the use of Osgide during pregnancy or lactation is currently not available. As a safety precaution, it is not recommended to use Osgide in women who are pregnant or breast feeding.
Warnings and Other information
The Osgide membrane may not be used when the sterile packaging is damaged.
The Osgide membrane can not be resterilized and is for single use only. A resterilization will lead to a deterioration of product properties and may result in unwanted biological reactions due to an unsterile product or to a treatment failure due to an early loss of the membrane´s barrier function.
Osgide has a shelf life of three years and should be stored at room temperature. Do not use after the expiry date as indicated on the packaging.
The manufacturer is not liable for an unintended or incorrect use of the Osgide membrane.
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