BIOBank Innovation: The Customized Bone Graft

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1 Preserved and regenerated human bone Innovation: The Customized Bone Graft

2 Concept A Customized Graft for bone apposition BENEFITS FOR SURGEONS: Easier planning of the surgery: properties and positioning of the graft can be established in advance on a 3D model Surgical time decrease: avoid the cutting/shaping phase necessary for standard bone blocks Congruence improvement between the graft and the host site Osteosynthesis facilitated and risks of micro-mobility minimized Greater graft / host bone contact surface for better osteoconduction Concept A Customized Graft for bone apposition BENEFITS FOR PATIENTS: Reduced opening time of the graft site Minimized postoperative complications (inflammation, infection, pain) Improved bone volume augmentation in terms of tissue quality and clinical efficiency 3

3 Protocol Concept Surgeon Step 1: Nominative prescription and CT Scan sent to (CD by post or DICOM files via internet) Step 2 (2 weeks): - Maxillary 3D modelling - Resin model printing - Resin model sent to the surgeon Total: 8 weeks Step 4 (5 weeks): - Silicone graft 3D scan - Machining, sterilization and delivery of bone graft Step 3: Silicone graft modelling (modelling template provided) Surgeon CT Concept scan: An important prerequisite! 1. For CT scan, minimum resolution: 400µm 2. For a Cone-Beam: Voltage 90 kv Max. field 100*100 mm 512*512 pixels per image Voxel size: 200 µm 3. In every case Insertion of a compress between the incisors to avoid occlusion Export of DICOM images using monoframe format (one.dcm file per slice)! If a scan does not meet these criteria, it cannot be processed (the surgeon will be notified by ) 4

4 Step Concept 1: The prescription Surgeon Identify the nature of the graft: cancellous or cortico-cancellous Determine the number of grafts according to the following maximum dimensions: cortico-cancellous graft: 22*15*9 mm cancellous graft: 32*15*9 mm Indicate the graft site (area and teeth) Send nominative prescription and DICOM files (CD-Rom or internet) to Biobank. Foresee 8 weeks before surgery. Biobank will send you an to confirm the compliance of the received data of your request. Step Concept 2: Bone modelling 3D bone patient modelling based on DICOM data 3D Resin model printing Resin model sent to the surgeon 3D modelling and printing based on Dicom images 5

5 Step 3: Graft conception Surgeon Conception by the surgeon of the ideal silicone graft (putty) directly on the resin model. For a cortico-cancellous graft, a template is provided to mold of the silicone graft in order to respect the natural curve of bone grafts. The surgeon send back by mail both resin model and silicone graft. See annex Step 4: Machining 3D scan of the silicone graft to generate a STL file. Bone graft machining by a CNC machine. Treatment of the custom graft by Supercrit Process followed by a gamma sterilization. Supercrit process The bone block is machined inaccordance with the STL file Sterile machined graft ready for use (cancellous version) 6

6 Step Concept 4 (continued): Delivery Delivery: Specific packaging with the patient name and surgery date Custom graft shipment at least 48 hours before the surgery Customized Bone Graft delivered together with the resin model and the silicone graft (all sterilized) Option: Sterile resin version of the graft provided to manage soft tissue Grafting Concept procedure 1 - Opening 2 - Rehydration 3 - Positioning 4 - Osteosynthesis 5 - Membrane (optional) 6 - Closing 7

7 Summary Concept Surgery time reduction Postoperative complications decrease Patient comfort improvement Optimal adjustment to host site Easy synthesis Easier surgery planning 8

8 SILICONE GRAFT MODELLING PROCEDURE PREPARE THE SILICONE PUTTY APPLY THE TEMPLATE ADJUST THE THICKNESS LEVEL OFF THE EXCESS ON OCCLUSAL FACE ADJUST THE EDGES CHAMFER THE SILICONE PUTTY Template USED TOOLS MODELING RESULT FINAL SILICONE GRAFT Please return the resin model and the silicone graft by mail to: Scalpel - Service Commercial Z.A Lavoisier - 4 rue Lebon Presles en Brie France

9 ZA Lavoisier - 4 rue Lebon Presles en Brie FRANCE Dental Backoffice: Fax: commercial@biobank.fr BT2-GB

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