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Combioss.

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Presentation on theme: "Combioss."— Presentation transcript:

1 combioss

2 The Bionic Solution Learning from nature...
humerus head, µ-CT, © Scanco AG ...to create the optimal bone void filler: porous inside, stable outside. combioss

3 Morphology Spherical granules
available in the range of 315 < ø < 1600µm Macroporous granules Porosity > 50% Interconnected micro-porosity Pore size ≈ 5µm

4 Morphology Comparison
combioss Competitor: dense structure

5 Crystal phase purity X-ray diffraction- (left) and infrared-spectrum (right) prove b-phase purity of > 99%

6 Chemical Composition Chemical pure b-TCP
Transmission [%] Transmission [%] combioss Competitor K Competitor C Competitor B Wavelength [cm-1] Wavelength [cm-1] Chemical pure b-TCP b-TCP with calcium pyrophosphate (K) b-TCP containing HA (B)

7 Solubility combioss is completely soluble! (ISO 109913-14)
F B K Solubility tests: pH 3, T = 37°C, 3 hours

8 Physical Properties Porosity Bulk density Abrasion Porosity [%]
Bulk density [gcm-3] C competitor combioss C competitor combioss C competitor combioss Porosity Bulk density Abrasion

9 Properties Pure-phase b-tricalciumphosphate (>99% b -TCP)
Interconnected porosity Porosity > 50% Osteoconductive 100% synthetic Spherical granules  315µm µm Simultaneous resorption to bone growth Complete resorption proven

10 Analytics Identity Phase purity by XRD and IR Porosity Bulk Density
All production processes are validated. The following parameters are analyzed for each production lot: Identity Phase purity by XRD and IR Porosity Bulk Density Mechanical stability of granules, Abrasion Granules geometry and color Complete solubility by ISO Heavy metals

11 Biocompatibility and Bone Formation
Light blue: pre existing bone Good biocompatibility Good osteoconductivity Granules are osteointegrated Degradation and resorption via solubility, osteoclastic action and macrophages Resorption rate depends on implantation site (loads, fluid exchange): months Complete resorption proven in scientific study in animal model Dark blue: new bone Combioss granules Sheep, super critical size hole model of 8mm in femur, after 2 months

12 Human Histology Osteointegration process of RootReplica™ (combioss) after 6 months, human histology of alveolar process Dark green: new bone Combioss granules Osteoid (red): bone formation in progress, Bone Formation within combioss granules Light green: undifferentiated tissue invaded by osteoids

13 Advantages Porous inside, stable outside Less material to fill defect
Taking up blood Minimal generation of small particles Complete resorption Pure b-phase >99% Purity > ASTM

14 Indications Filling of bone defects after extirpation of cysts
Defects in corrective osteotomy Defects after the extraction of a tooth Sinus floor elevation surgery Periodontal and peri-implants defects Defects after harvesting of autogenous bone Augmentation of alveolar bone

15 Available Sizes Ref-Nr. Content Granule Size CBO-0500-05 5 x 0.5 ml

16 Case Report Initial X-rays Detachment

17 Case Report Detachment Detachment

18 Case Report Impacted canine tooth Extraction of impacted canine tooth

19 Case Report Post-extraction socket Cavity filling with Combioss

20 Case Report Cavity filling with Combioss and CGF
Cavity filling with CGF membrane

21 Case Report Cavity filling with CGF membrane
Stitched wound, covered with serum

22 Case Report Stitched wound, covered with serum 3 days after surgery

23 Case Report Quality of the tissues after 3 days X-rays after 45 days


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