Inion GTR Biodegradable Membrane System

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2 Inion GTR Biodegradable Membrane System The concept of GTR/GBR Intended use The Inion GTR Biodegradable Membrane System is intended to be used as a barrier membrane in dental guided tissue regeneration (GTR) and guided bone regeneration (GBR) procedures. System description Inion GTR Biodegradable Membrane System consists of membranes and tacks made of biodegradable co-polymers composed of L-lactic, D-lactic, glycolic acid and trimethylene carbonate. These polymers degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolised by the body. The membrane provides a barrier over 8-12 weeks in vivo, and resorbs thereafter. The plasticiser provided temporarily softens the membrane and is used to facilitate the handling and shaping of membranes. Guided tissue regeneration (GTR) The aim of modern treatment for periodontal disease is to regenerate lost periodontal and supporting bone tissues. Selected cell populations residing in the periodontal tissues can produce new periodontal soft tissue, cementum and alveolar bone tissue, provided that these populations are given the opportunity to occupy a fresh periodontal wound. Treatment includes the use of bone grafts, and/or bone graft substitutes with GTR membranes or of membranes alone. With guided tissue regeneration (GTR, membrane therapy), the faster growing connective tissue and epithelial cells are prevented from migrating into the wound and space is maintained between the membrane and bone, allowing time for periodontal ligament, cementum and bone to repopulate and mature in the defect area. Inion GTR Biodegradable Membrane System implants are supplied sterile and are non-collagenous. Indications The Inion GTR Biodegradable Membrane System is indicated for the surgical treatment of periodontal defects (e.g. class II furcation defects, intrabony defects and recession type defects), for pre-implant and peri-implant surgery and for covering bone defects and empty sockets. Guided bone regeneration (GBR) Post-operative X-ray Because bone tissue heals more slowly than mucoperiosteal tissue in the mouth, the faster healing soft tissue would prevent the bone from maximising its full healing potential following a surgical procedure. The concept of guided bone regeneration (GBR) treatment suggests that if a biocompatible membrane is placed between the soft tissue and bone, the membrane acts as a barrier. This barrier prevents the down-growth of the soft tissue, connective and epithelial cells into the underlying bony space during its healing period. GBR is used in pre-implant and peri-implant surgery, bony defects and extraction sockets. 3

3 The Inion Biomaterial Advantage The need for removal surgery is eliminated by using Inion GTR membranes. Biodegradable materials are safe and synthetic, eliminating the risk of disease transmission from materials of human or animal origin. The polymers used in the Inion membranes and tacks degrade in vivo by hydrolysis into alphahydroxy acids that are metabolised by the body into CO 2 and water. Since the 1970s, the excellent biocompatibility of PLA has been documented in hundreds of publications. The biocompatibility of co-polymers of polylactic and polyglycolic acids (PLGA) has been shown to be comparable to that of PLA. These same polymers have been clinically used for more than 30 years in biodegradable sutures and osteosynthesis devices. Membrane TMC Trimethylene Carbonate LPLA L-Lactide PGA Polyglycolide Tack TMC Trimethylene Carbonate DLPLA D, L-Lactide 5

4 The Benefits of Inion GTR Biodegradable Membrane System Cross-sectional cut showing 3 layer structure of the membrane High magnification showing surface morphology of the membrane Space maintenance * Improved space maintenance and membrane geometry due to unique material characteristics The Inion GTR membrane is the first GTR membrane that is soft when applied, but becomes rigid in-situ Spacemaking material Non-spacemaking material Cell exclusion * The 3 layer (porous/dense/porous) structure of the Inion GTR membrane is designed to prevent the gingival cells from penetrating the membrane Preclinical histological analysis of defect treated with Inion GTR membrane shows in-growth of cells into the membrane surface Bone Biocompatibility * Biodegradable: no removal surgery needed Safe and synthetic biomaterials (eliminates the risk of disease transmission from materials of human or animal origin) Inion GTR membrane Tissue integration * Preclinical histological analysis of defects treated with Inion GTR membrane shows in-growth of cells into the membrane surface In-growth of cells *Design criteria according to Tatakis et al. Periodontology 2000, vol.19,

5 The Benefits of Inion GTR Biodegradable Membrane System Ease of use * For easy handling and reduced inventory, the Inion GTR membrane is supplied in one standard size (30 x 40 mm) together with three different shaping templates The membrane is easy to cut to the desired shape The membrane is easily adapted for optimal placement Membranes can be quickly attached with the tacks - no suturing is necessary, but sutures can be used in combination with Inion GTR membranes, if needed It is possible to drill directly through the membrane, for immediate tack placement Fully reversible 3 layer structure A Biological activity * In vivo results with 6 mm diameter cranial defects did show a significant acceleration of bone healing in defects treated with Inion GTR membrane (A) when compared to untreated control defects (B). Shown on the right are representative middle sections of defects harvested after 4 weeks. In the histosections, bone is shown in green and osteoid in red due to the Goldner-Trichrome staining. Further preclinical studies are ongoing to confirm this observation. Defect B *Design criteria according to Tatakis et al. Periodontology 2000, vol.19, Defect 8

6 Preparation and fastening of the Inion GTR membrane Preparation of the membrane Start the preparation of the membrane when starting the surgical procedure. The membrane is supplied in one standard size (30 x 40 mm) together with three different shaping templates and a bottle of plasticiser. The membrane and templates are packed in a plastic blister. After opening the blister, remove the templates from the blister before starting the membrane preparation. 1. Pour all the plasticiser from the bottle onto the membrane (which is already in compartment A of the blister pack). 2. Leave the membrane to soak in the plasticiser for seconds. (NOTE: Longer immersion time may compromise mechanical properties.) 3. Lift the membrane out with non-toothed forceps, letting excess plasticiser drip away. 4. Place the membrane in compartment B to cure for at least 10 minutes, during which it becomes very flexible. 5. Trim the membrane to the desired shape using sterile surgical scissors. The preshaped templates are provided as an aid to shaping. Discard the templates after use do NOT implant. Take care to round any sharp edges or corners of the trimmed membrane before implantation to prevent irritation of the soft tissues. At normal room temperature and humidity, the membrane stays malleable for several hours. When exposed to water, as in the mouth, the membrane starts to stiffen. The stiffness lasts as long as the membrane remains intact and will reach maximum stiffness after 30 minutes. The stiffening of the membrane can be accelerated by copious flushing with sterile water prior to implantation or once the membrane has been secured into position. If stiffened prior to implantation take care to ensure the membrane is adequately adapted to prevent soft tissue irritation. Fastening a membrane with tacks The Tacks are supplied in a plastic dispenser. Open the dispenser carefully to avoid dislodging any Tacks. 1. Take the Tack Applicator and press it firmly onto the Tack head to fasten the Tack to the Applicator. 2. Hold the membrane securely in the desired position and drill directly through it into the bone. 3. While keeping the membrane immobile, take the loaded Tack Applicator and press the tack firmly into the hole. When using the angled end, apply finger pressure to the head of the Applicator and not to the shaft. 4. Angle the Tack Applicator slightly to release it from the tack. 6. Secure the membrane in position with Inion biodegradable Tacks or suture it in place. 10

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