1 combioss. 2...to create the optimal bone void filler: porous inside, stable outside. learning from...
TRANSCRIPT
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combioss
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...to create the optimal bone void filler: porous inside, stable outside.
Learning from nature...
The Bionic Solution
humerus head, µ-CT, © Scanco AG
combioss
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Morphology
Spherical granulesavailable in the range of 315 < ø < 1600µm
Macroporous granulesPorosity > 50%
Interconnected micro-porosityPore size ≈ 5µm
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Morphology Comparison
combioss
Competitor: dense structure
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Crystal phase purity
X-ray diffraction- (left) and infrared-spectrum (right) prove -phase purity of > 99%
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01000200030004000
Wavelength [cm-1]
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Chemical Composition
Chemical pure -TCP -TCP with calcium pyrophosphate (K)-TCP containing HA (B)
Tra
nsm
issi
on [
%]
Tra
nsm
issi
on [
%]
Wavelength [cm-1] Wavelength [cm-1]
combioss
Competitor CCompetitor K
Competitor B
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Solubility
COMBIOSS C KBF
Solubility tests: pH 3, T = 37°C, 3 hours
combioss is completely soluble! (ISO 109913-14)
So
lub
ilit
y [%
]
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Ab
rasi
on
[%
]
Abrasion Bulk densityPorosity
C competitor combioss
Po
rosi
ty
[%]
Bu
lk d
ensi
ty
[gcm
-3]
C competitor combioss C competitor combioss
Physical Properties
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Pure-phase -tricalciumphosphate (>99% -TCP) Interconnected porosity Porosity > 50% Osteoconductive 100% synthetic Spherical granules 315µm - 1600µm Simultaneous resorption
to bone growth Complete resorption proven
Properties
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Analytics
Identity Phase purity by XRD and IR Porosity Bulk Density Mechanical stability of granules, Abrasion Granules geometry and color Complete solubility by ISO 109913-14 Heavy metals
All production processes are validated. The following parameters are analyzed for each production lot:
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Biocompatibility and Bone Formation
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): 9 - 15 months
Complete resorption proven in scientific study in animal model
Sheep, super critical size hole model of 8mm in femur, after 2 months
Combioss granules
Light blue:
pre existing bone
Dark blue: new bone
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Human Histology
Osteoid (red): bone formation in progress,
Bone Formation within combioss granules
Osteointegration process of RootReplica™ (combioss) after 6 months, human histology of alveolar process
Dark green: new bone
Combioss granules
Light green: undifferentiated tissue invaded by osteoids
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Advantages
Less material to fill defect Taking up blood Minimal generation of small
particles
Porous inside, stable outside
Complete resorption
Pure -phase >99% Purity > ASTM
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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
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Available Sizes
Ref-Nr. Content Granule Size
CBO-0500-05 5 x 0.5 ml 315 - 500 µm
CBO-0500-10 5 x 1.0 ml 500 - 1000 µm
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Case Report
Initial X-rays Detachment
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Case Report
Detachment Detachment
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Case Report
Impacted canine tooth Extraction of impacted canine tooth
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Case Report
Post-extraction socket Cavity filling with Combioss
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Case Report
Cavity filling with Combioss and CGF Cavity filling with CGF membrane
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Case Report
Cavity filling with CGF membrane Stitched wound, covered with serum
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Case Report
Stitched wound, covered with serum 3 days after surgery
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Case Report
Quality of the tissues after 3 days X-rays after 45 days