Literature maxresorb® und maxresorb® inject
Studies on biphasic calcium phosphates
Backgound/ physic-chemical studies
Biphasic calcium phosphate bioceramics: preparation, properties and applications.
LeGeros RZ, Lin S, Rohanizadeh R, Mijares D, LeGeros JP., J Mater Sci Mater Med. 2003 Mar;14(3):201-9.
Abstract
Biphasic calcium phosphate (BCP) bioceramics belong to a group of bone substitute biomaterials that
consist of an intimate mixture of hydroxyapatite (HA), Ca(10)(PO(4))(6)(OH)(2), and beta-tricalcium
phosphate (beta-TCP), Ca(3)(PO(4))(2), of varying HA/beta-TCP ratios. BCP is obtained when a synthetic
or biologic calcium-deficient apatite is sintered at temperatures at and above 700 degrees C. Calcium
deficiency depends on the method of preparation (precipitation, hydrolysis or mechanical mixture)
including reaction pH and temperature. The HA/beta-TCP ratio is determined by the calcium deficiency
of the unsintered apatite (the higher the deficiency, the lower the ratio) and the sintering temperature.
Properties of BCP bioceramics relating to their medical applications include: macroporosity,
microporosity, compressive strength, bioreactivity (associated with formation of carbonate
hydroxyapatite on ceramic surfaces in vitro and in vivo), dissolution, and osteoconductivity. Due to the
preferential dissolution of the beta-TCP component, the bioreactivity is inversely proportional to the
HA/beta-TCP ratio. Hence, the bioreactivity of BCP bioceramics can be controlled by manipulating the
composition (HA/beta-TCP ratio) and/or the crystallinity of the BCP. Currently, BCP bioceramics is
recommended for use as an alternative or additive to autogeneous bone for orthopedic and dental
applications. It is available in the form of particulates, blocks, customized designs for specific applications
and as an injectible biomaterial in a polymer carrier. BCP ceramic can be used also as grit-blasting
abrasive for grit-blasting to modify implant substrate surfaces. Exploratory studies demonstrate the
potential uses of BCP ceramic as scaffold for tissue engineering, drug delivery system and carrier of
growth factors.
Effect of surface structure on protein adsorption to biphasic calcium-phosphate ceramics in vitro and
in vivo.
Zhu XD, Fan HS, Xiao YM, Li DX, Zhang HJ, Luxbacher T, Zhang XD., Acta Biomater. 2009 May;5(4):1311-8.
Epub 2008 Dec 10.
Abstract
Protein adsorption affects the function of cells and determines the bioactivity of biomaterial implants.
Surface structure and properties of materials determine the behavior of protein adsorption. In the
present study, two biphasic calcium-phosphate ceramics (BCPs) with different surface structures were
fabricated by pressing and H2O2 foaming methods. Their surface characteristics were analyzed and the
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in vitro and in vivo protein adsorption on them was investigated. Porous BCP showed higher ability to
adsorb proteins, and transforming growth factor-beta1 (TGF-beta1) adsorption notably increased with
increasing in vivo implantation time. The strong affinity of BCP to TGF-beta1 might provide important
information for exploring the mechanism of the osteoinduction of calcium phosphates.
Animal studies
Evaluation of a novel biphasic calcium phosphate in standardized bone defects: a histologic and
histomorphometric study in the mandibles of minipigs.
Jensen SS, Yeo A, Dard M, Hunziker E, Schenk R, Buser D., Clin Oral Implants Res. 2007 Dec;18(6):752-60.
Epub 2007 Sep 20.
Abstract
OBJECTIVE: A novel biphasic calcium phosphate (CaP) granulate consisting of hydroxyapatite (HA) and
beta-tricalciumphosphate (TCP) was compared with pure HA and pure TCP and with autograft as positive
control.
MATERIALS AND METHODS: Four standardized bone defects were prepared in both mandibular angles of
16 minipigs and grafted with autogenous bone chips, HA, HA/TCP (60% : 40%), or TCP. Histologic and
histomorphometric analysis of bone formation and graft degradation followed healing periods of 2, 4, 8,
and 24 weeks.
RESULTS: 2 weeks: more bone formation in defects filled with autograft than with the three CaP
materials (P<0.05). 4 weeks: bone formation differed significantly (P<0.05) between all four materials
(autograft>TCP>HA/TCP>HA). 8 weeks: more bone formation in defects with autograft and TCP than with
HA/TCP (P<0.05), and HA/TCP had more bone formation than HA (P<0.05). 24 weeks: no difference in
bone formation between the groups. Autograft and TCP resorbed quickly and almost completely over 8
weeks, whereas HA/TCP and HA showed limited degradation over 24 weeks.
CONCLUSION: All defects healed with mature lamellar bone and intimate contact between bone and the
remaining graft material. The rate of bone formation corresponded to the content of TCP in the CaP
materials.
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Osteogenicity of biphasic calcium phosphate ceramics and bone autograft in a goat model.
Fellah BH, Gauthier O, Weiss P, Chappard D, Layrolle P., Biomaterials. 2008 Mar;29(9):1177-88.
Abstract
The aim of this work was to compare the osteogenicity of calcium phosphate ceramic granules with
autologous bone graft in ectopic and orthotopic sites. Biphasic calcium phosphate (BCP) granules
composed of hydroxyapatite (HA) and beta-tricalcium phosphate (beta-TCP) in a 60/40 ratio were
sintered at 1050, 1125 and 1200 degrees C, producing different microporosities. Either BCP ceramic
granules or autologous bone chips (n=7) were implanted into paraspinal muscles. Osteoinduction was
not observed in either the BCP implants or autologous bone chips after 6 or 12 weeks in the ectopic
sites. Hollow and bored polytetrafluoroethylene (PTFE) cylinders were filled with autologous bone, BCP
granules or left empty, then implanted into critical-sized defects in femoral epiphyses. The PTFE cylinders
left empty contained marrow and blood vessels but not mineralized bone, indicating that this model
prevented bone ingrowth (0.56+/-0.43% at 12 weeks). Bone formation was observed in contact with the
BCP1050 and BCP1125 granules in the femoral sites after 6 weeks. The amount of bone after 12 weeks
was 5.6+/-7.3 and 9.6+/-6.6% for BCP1050 and BCP1125, respectively. Very little bone formation was
observed with the BCP1200 implants (1.5+/-1.3% at 12 weeks). In both the ectopic and orthotopic sites,
autologous bone chips were drastically resorbed (from 19.4+/-3.7% initially to 1.7+/-1.2% at 12 weeks).
This study shows that synthetic bone substitutes may have superior stability and osteogenic properties
than autologous bone grafts in critical-sized bone defects.
Comparative study of biphasic calcium phosphates with different HA/TCP ratios in mandibular bone
defects. A long-term histomorphometric study in minipigs.
Jensen SS, Bornstein MM, Dard M, Bosshardt DD, Buser D., J Biomed Mater Res B Appl Biomater. 2009
Jul;90(1):171-81.
Abstract
Three biphasic calcium phosphate (BCP) bone substitute materials with hydroxyapatite (HA)/tricalcium
phosphate (TCP) ratios of 20/80, 60/40, and 80/20 were compared to coagulum, particulated
autogenous bone, and deproteinized bovine bone mineral (DBBM) in membrane-protected bone
defects. The defects were prepared in the mandibles of 24 minipigs that were divided into four groups of
six with healing times of 4, 13, 26, and 52 weeks, respectively. The histologic and histomorphometric
evaluation focused on differences in amount and pattern of bone formation, filler degradation, and the
interface between bone and filler. Collapse of the expanded polytetrafluoroethylene barrier membrane
into the coagulum defects underlined the necessity of a filler material to maintain the augmented
volume. Quantitatively, BCP 20/80 showed bone formation and degradation of the filler material similar
to autografts, whereas BCP 60/40 and BCP 80/20 rather equaled DBBM. Among the three BCP's, the
amount of bone formation and degradation of filler material seemed to be inversely proportional to the
HA/TCP ratio. The fraction of filler surface covered with bone was highest for autografts at all time points
and was higher for DBBM than BCP 80/20 and 60/40 at the early healing phase. TRAP-positive
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multinucleated cells were identified on BCP and DBBM surfaces without showing typical signs of
resorption lacunae.
Studies on Maxresorb (Osceram nano)
Cellular and Animal studies
Oberflächenstruktur, Biokompatibilität und Hartgewebsregeneration
(Wissenschaftlich-experimentelle Untersuchung des biphasischen Knochenersatzmaterials Ossceram
nano)
Dr.Dr.Daniel Rothamel, Dr. Jörg Neugebauer, Dr. Thea Lingohr, Dr.Dr. Timo Dreiseidler, Dr. Lutz Ritter
und Prof.Dr.Dr. Joachim Zöller, Köln
Bei augmentativen Eingriffen in der dentalen Implantologie sind neben der Verwendung von
Eigenknochen verschiedene xenogene und alloplastische Knochenersatzmaterialien etabliert. Sie zeigen
je nach Indikationsstellung vorhersagbare Ergebnisse, bei gleichzeitiger Verringerung der
Entnahmemorbidität. Ziel der vorliegenden Untersuchung war die wissenschaftliche Betrachtung eines
neuartigen biphasischen Knochenersatzmaterials (Ossceram nano, Bredent medical). Hierfür wurden
rasterelektronenmikroskopische sowie zell- und tierexperimentelle Untersuchungen durchgeführt. In der
rasterelektronenmikroskopischen Oberflächenanalyse zeigte sich, dass das Material neben einer
hochporösen Makro- und Mikrotopographie auch nanostrukturelle Anteile aufweist. In-vitro war eine
gute Proliferation von Knochenzellen zu beobachten. Tierexperimentell zeigten sich 4 Wochen nach
lateraler Augmentation im Oberkiefer erste Anzeichen für eine ossäre Regeneration und nach 8 Wochen
eine vollständige Durchbauung des Augmentates mit Geflechtknochen. Dieser wurde innherhalb von 24
Wochen bei langsamer oberflächlicher Resorption des Materials in Lamellenknochen umgebaut. Es ließ
sich schlussfolgern, dass sich das untersuchte Knochenersatzmaterial durch hohe Porösität und gute
Biokompatibilität auszeichnet, schnell osseointegriert wird und eine deutliche Volumenstabilität und
langsame Resorption aufweist.
Surface morphology, biocompatibility and osseous organization of a new biphasic bone substitute
(Maxresorb®). A combined in-vitro/in-vivo analysis.
Rothamel, Daniel; Neugebauer, Joerg; Scheer, Martin; Ritter, Lutz; Dreiseidler, Timo; Lingohr, Thea;
Mischkowski, Robert; Zoeller, Joachim
The aim of the present study was to investigate surface morphology, biocompatibility and osseous
organisation of a new biphasic bone substitute (Maxresorb (MR), 60% HA/40% ß-TCP, Botiss dental
GmbH, Berlin, Germany).
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Wissenschaftlich-experimentelle Untersuchung des biphasischen Knochenersatzmaterials Ossceram
nano: Oberflächenstruktur, Biokompatibilität und Hartgewebsregeneration
Dr.Dr. Daniel Rothamel, Dr. Jörg Neugebauer, Dr. Thea Lingohr, Dr.Dr. Timo Dreiseidler, Dr. Lutz Ritter
und Prof.Dr.Dr. Joachim Zöller, Z Oral Implant, 5. Jahrgang 2/2009
Bei augmentativen Eingriffen in der dentalen Implantologie sind neben der Verwendung von
Eigenknochen verschiedene xenogene und alloplastische Knochenersatzmaterialien etabliert. Sie zeigen
je nach Indikationsstellung vorhersagbare Ergebnisse, bei gleichzeitiger Verringerung der
Entnahmemorbidität. Ziel der vorliegenden Untersuchung war die wissenschaftliche Betrachtung eines
neuartigen biphasischen Knochenersatzmaterials (Ossceram nano, Bredent medical). Hierfür wurden
rasterelektronenmikroskopische sowie zell- und tierexperimentelle Untersuchungen durchgeführt. In der
rasterelektronenmikroskopischen Oberflächenanalyse zeigte sich, dass das Material neben einer
hochporösen Makro- und Mikrotopographie auch nanostrukturelle Anteile aufweist. In-vitro war eine
gute Proliferation von Knochenzellen zu beobachten. Tierexperimentell zeigten sich 4 Wochen nach
lateraler Augmentation im Oberkiefer erste Anzeichen für eine ossäre Regeneration und nach 8 Wochen
eine vollständige Durchbauung des Augmentates mit Geflechtknochen. Dieser wurde innherhalb von 24
Wochen bei langsamer oberflächlicher Resorption des Materials in Lamellenknochen umgebaut. Es ließ
sich schlussfolgern, dass sich das untersuchte Knochenersatzmaterial durch hohe Porösität und gute
Biokompatibilität auszeichnet, schnell osseointegriert wird und eine deutliche Volumenstabilität und
langsame Resorption aufweist.
Oberflächenstruktur, Biokompatibilität und Hartgewebsregeneration eines nanostrukturierten
biphasischen Knochenersatzmaterials. Eine in-vitro- und tierexperimentelle Pilotstudie.
D. Rothamel, D. Neugebauer, T. Lingohr, T. Dreiseidler, L. Ritter und J. Zöller, Report Uniklinik Köln
Zusammenfassung Bei augmentativen Eingriffen in der dentalen Implantologie sind neben der Verwendung von
Eigenknochen verschiedene xenogene und alloplastische Knochenersatzmaterialien etabliert. Sie zeigen
je nach Indikationsstellung vorhersagbare Ergebnisse, bei gleichzeitiger Verringerung der
Entnahmemorbidität. Ziel der vorliegenden Untersuchung war die wissenschaftliche Betrachtung eines
neuartigen biphasischen Knochenersatzmaterials (maxresorb, botiss dental, Berlin). Hierfür wurden
rasterelektronen-mikroskopische sowie zellund tierexperimentelle Untersuchungen durchgeführt. In der
rasterelektronenmikroskopischen Oberflächenanalyse zeigte sich, dass das Material maxresorb neben
einer hochporösen Makro- und Mikrostruktur auch nanoporöse Anteile aufweist. In-vitro war eine gute
Proliferation von Knochenzellen auf dem Mineral maxresorb zu beobachten. Tierexperimentell ließen
sich nach lateraler Augmentation im Oberkiefer nach 4 Wochen Heilungsperiode erste Anzeichen für
eine ossäre Regeneration feststellen. Nach 8 Wochen Heilungsperiode zeigte sich eine vollständige
Durchbauung des maxrsorb Augmentates mit Geflechtknochen, der im weiteren Verlauf bis zu 24
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Wochen maximaler Heilungsperiode bei nur sehr langsamer oberflächlicher Resorption des Materials in
Lamellenknochen umgebaut wurde. Es ließ sich schlussfolgern, dass sich das untersuchte
Knochenersatzmaterial maxresorb durch hohe Porösität und gute Biokompatibilität auszeichnet, schnell
osseointegriert wird und eine deutliche Volumenstabilität und langsame Resorption aufweist.
Surface structure, biocompatibility and hard tissue regeneration of nanostructured biphasic
calciumphosphate cereamic and natural bovine deproteinized bone matrix. An in-vitro and in-vivo
analysis.
D. Rothamel, T. Fienitz, A. Happe und J. Zöller, report University cologne
Summary
Alongside the use of the patient's own bones, various xenogenic and alloplastic bone substitute
materials are established for use in augmentation surgery in dental implantology. They yield results
which are predictable according to the respective indications for treatment, with a simultaneous
reduction of donor-site morbidity. The aim of this study was the scientific analysis of a new type of
biphasic bone substitute material (Maxresorb [MR], Botiss Dental, GmbH Berlin) in comparision to a
natural bovine bone mineral (Bio Oss Spongiosa [BOS], Geistlich Biomaterials, Wolhusen, Switzerland).
To this end, scanning electron microscope analyses and cell and animal experiments were performed.
The scanning electron microscope surface analysis revealed that the MR material has nanoporous parts
in addition to a highly porous macro- and microstructure. BOS showed a more smooth surface at 500x
magnification. A good proliferation of bone cells was observed on MR, whereas BOS revealed some
limitations on cell attachment and proliferaton in-vitro. Therefore, initial attachment as well as
proliferation were significantly better on MR than BOS (P<0.05, Mann Whitney U-Test). In the animal
experiments, following a lateral augmentation of the maxilla in eight animals, the first signs of osseous
regeneration in MR were observed after a healing period of 4 weeks. After a healing period of 8 weeks,
there was a complete union of the MR augmentation material with woven bone. BOS showed a more
delayed bone formation, originating from the bottom of the defect. After 24 weeks of healing, the
woven bone was converted into lamellar bone, with a very slow surface resorption of MR. BOS showed
no resorption of the granules and a more delayed bone maturation, whereas volume stability was found
excellent in both groups. It was concluded that both MR and BOS show good biocompatibility,
supporting osseointegration with marked volume stability and slow resorption.
Report on the in-vivo response of bone to granules of porous Hydroxyapatite / Tri-calcium phosphate
(maxresorb)
C.O. Freeman, I.M. Brook; School of Dentistry, Biomaterials research cluster, report
Conclusion:
The maxresorb granules were osteoconductive (Figures 1-23) with clear evidence of new bone formation
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occurring in intimate association to the implanted granules in the larger pores of both materials. There
was evidence of complete (~100%) osseointegration of the maxresorb granules at the 12 week time
point in this rat femora model. The hard and soft tissues accepted the presence of maxresorb granules
and with no evidence of any adverse effect.
In vivo determination of the biocompatibility of calcium phosphate bioceramics (maxresorb)
implanted in a nonhealing mandibular ramus model.
C.O. Freeman, I.M. Brook, University of Sheffield, research report
Conclusions:
New bone failed to develop in the control defects.The HA/bTCP (Maxresorb) is osteoconductive with
clear evidence of new bone formation in the larger pores of both materials. There was evidence of good
osseointegration of HA/bTCP (Maxresorb). The hard and soft tissues accepted the presence of HA/bTCP
(Maxresorb) with no evidence of any adverse effect. There was no evidence of any fibrous encapsulation
of HA/bTCP (Maxresorb).
Clinical Studies
Clinical Performance of a New Biphasic ß-TCP/Hydroxyapatite Ceramic. A Consecutive Case Report
Study
Daniel Rothamel, Jörg Neugebauer, Tim Fienitz, Martin Scheer, Robert Mischkowski, Timo Dreiseidler,
Lutz Ritter, Joachim Zöller; Poster AO 2011
Beside autogenic bone, different bone substitute materials are well established for augmentation
procedures in oral implantology. Whereas tricalciumphosphate ceramics have shown fast osseous
organisation but low volume stability, complete osseous organization of native and synthetic
hydroxyapatite ceramics (HA) may last much longer resulting in prolonged healing times. The
combination of both ceramics as biphasic HA/ß-TCP could hypothetically combine the fast regeneration
of ß-TCP and volume stability of HA due to its specific chemical composition. The aim of this case report
study was to investigate a new biphasic ß-TCP/HA ceramic (Maxresorb® [MR], 60% HA/40% ß-TCP, Botiss
dental GmbH, Berlin, Germany) for lateral augmentations in GBR technique and single-stage and twostage sinus floor elevations.
Clinical Performance of a New Biphasic Bone Substitute Material for Sinus Grafting
Dr. Franziska Möller, Dr. Dr. Martin Scheer, PD Dr. Dr. Daniel Rothamel, PD Dr. Jörg Neugebauer, Dr.
Thea Lingohr, Dr. Dr. Timo Dreiseidler, Dr. Lutz Ritter, Prof. Dr. Dr. Joachim Zöller, Poster AO 2010
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Conclusion
Within the limits of the present study it was concluded that the use of maxresorb® for one-stage or twostage sinus floor elevations shows fast osseous organization, good volume maintenance and slow
resorption. Particularly the good volume maintenance may increase the predictability of two-stage
implant treatments in the atrophic posterior maxilla.
Clinical aspects of novel types of collagen membranes and matrices
Current issues in soft- and hard-tissue augmentation (Osceram nano)
D. Rothamel, R. Torök, J.Neugebauer, T. Fienitz, M. Scheer, M. Kreppel, R.Mischkowski, J. Zöller; EDI
Journal 1rst Issue 2011
In recent years, the use of bone substitutes has increasingly become established for augmenting
localized defects of the alveolar ridge as an alternative to autologous bone grafts. Bone substitutes are
available in unlimited quantities, are not associated with any harvest-related morbidity and are well
accepted by patients. To prevent connective-tissue encapsulation of the material introduced, it should
be separated from the adjacent soft tissue by membranes, following the principles of guided tissue
regeneration (GTR). However, it should be noted that especially resorbable collagen membranes differ
with regard to their handling properties and mechanism of biodegradation and, hence, the resulting
incidence of complications. But technical progress in the area of collagenous membranes has led to
thicker collagen matrices with more stable volumes, opening up new possibilities. New indications for
these matrices might reduce the morbidity related to the harvesting of palatal soft-tissue grafts.
Reports/ Statements
Clinical report/ statement about the synthetic material maxresorb®
Dr. Damir Jelusic, Stomatoloska Poliklinika; Opatja, Hrvatska, Croatia, July 2011
Scientific and clinical report about Maxresorb® (Botiss Biomaterials, Berlin, Germany)
Dr. Daniel Rothamel, Uniklinik Köln
Statement on maxresorb®
Kathrin Berndsen, DMD, Praxis Mundart, Ratingen, November 2011
Bericht Trepanproben nach Sinuslift
Dr. D. Rothamel, Uniklinik Köln, 16. November 2010
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Protokoll zur Analyse von Knochenersatzmaterial
Analyses of bone graft materials
Universität Hannover, Prof. Carla Vogt, 2011
Studies on maxresorb® inject
Animal studies
Bone regeneration following socket preservation using different bone substitute materials. A pilot
study in dogs.
D. Rothamel and D. Ferrari, report University of cologne/ University of Duesseldorf
Purpose:
The aim of the present study was to histologically evaluate hard tissue healing following application of
bone substitutes into fresh extraction sockets in dogs.
Methods:
The following groups were tested: (i) Ceramisys granulated HA nanopaste [GNP] (Maxresorb HA/TCP
granulates 16.5% combined within Nano HA Bone Paste 83.5%, Ceramisys Ltd, Sheffield, UK) (ii) selfhardening bone cementum [OC] (Bone Cement, AAP biomaterials, Dieburg, Germany), (iii) CaSO4-Pellets
[POS] (PerOssal, botiss dental GmbH, Berlin, Germany). The materials were randomly inserted in the
extraction sockets immediately after tooth extraction. Untreated extraction sites served as control (C).
After eight weeks, the animals were sacrified and dissected blocks were prepared for
histomorphometrical analysis (n=4). Results:
During the entire study period, healing was uneventful for all animals. Histological analysis revealed a
high variability of material resorption and osteoconductive properties of the applied materials. Similar to
POS, the nanopaste part of GNP was completely resorbed within eight weeks, whereas the granular part
of GNP and OC could still be identified within the extraction sockets. In contrast to the GNP granules
being osseoconductively integrated into the newly formed bone, major parts of the OC remnants
displayed a fibrous encapsulation and less hard tissue regeneration. Conclusions:
Within the limits of the present study it was concluded that POS and GNP supported, whereas OC
inhibited hard tissue healing following tooth extraction. GNP may be generally considered as suitable
material for use in bone tissue repair and augmentation.
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Dimensional ridge alterations following socket preservation using a nanocrystalline hydroxyapatite
paste: a histomorphometrical study in dogs.
Rothamel D, Schwarz F, Herten M, Engelhardt E, Donath K, Kuehn P, Becker J., Int J Oral Maxillofac Surg.
2008 Aug;37(8):741-7. Epub 2008 Jun 12.
Abstract
The aim of the study was to evaluate the histological response and dimensional ridge alterations
following application of a nanocrystalline hydroxyapatite paste (NHA) into fresh extraction sockets in
dogs. Immediately following vertical tooth separation and extraction, NHA was inserted in the extraction
socket of the second molar in the lower jaws of 10 dogs. Untreated extraction sites on the opposite side
served as controls. Wounds were closed using resorbable sutures after vertical flap elevation. After three
and six months, 5 animals were killed. Lingual and buccal bone height, alveolar wall and total bone width
1, 3 and 5mm underneath the top of the crest were evaluated. Histological analysis revealed a high
variability of NHA resorption and osteoconductive properties with different rates of material resorption.
No statistically significant differences could be observed between the corresponding aspects of test and
control sites. Both groups revealed higher alveolar wall resorption on the buccal than on the lingual side
at both time periods. NHA does not seem to be useful for socket preservation procedures since it failed
to prevent dimensional ridge alterations while revealing osseous integration but unpredictable material
resorption. The role of non-resorbed hydroxyapatite remnants for implant placement is unclear and
requires further investigation.
Ostim: Evaluation of a novel nanocrystalline hydroxyapatite paste and a solid hydroxyapatite ceramic
for the treatment of critical size bone defects (CSD) in rabbits.
Huber FX, Berger I, McArthur N, Huber C, Kock HP, Hillmeier J, Meeder PJ. J Mater Sci Mater Med. 2008
Jan;19(1):33-8. Epub 2007 Jun 14.
Abstract
The purpose of our study was to test the effectiveness of Ostim nanocrystalline hydroxyapatite paste
and Cerabone ceramic by treating a critical size bone defect (CSD) on the right foreleg of a white New
Zealand rabbit. Evaluation was carried out by comparing four groups each with a different CSD filling: an
only OSTIM bone filling, an only Cerabone filling, an OSTIM-Cerabone combination, and a control group
with no filling of the CSD. The results of this study display a rapid and uniform bone ingrowth following
the CSD filling with Ostim. The histological and histomorphometrical data have shown similarly excellent
results for both the Ostim and Cerabone-Ostim groups. The control group faired poorly in comparison, as
three cases of non-union were observed and none of the defects were totally refilled with fresh bone
within 60 days. The successful bone healing with osseous consolidation verifies the importance of the
nanocrystalline hydroxyapatite in the treatment of metaphyseal osseous volume defects in the
metaphyseal spongiosa.
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Ostim: Injectable nanocrystalline hydroxyapatite paste for bone substitution: in vivo analysis of
biocompatibility and vascularization.
Laschke MW, Witt K, Pohlemann T, Menger MD. J Biomed Mater Res B Appl Biomater. 2007
Aug;82(2):494-505.
Abstract
The nanocrystalline hydroxyapatite paste Ostim represents a fully degradable synthetic bone substitute
for the filling of bone defects. Herein, we investigated in vivo the inflammatory and angiogenic host
tissue response to this biomaterial after implantation. For this purpose, Ostim was implanted into the
dorsal skinfold chambers of Syrian golden hamsters. The hydroxyapatite ceramic Cerabone and isogeneic
transplanted cancellous bone served as controls. Angiogenesis, microhemodynamics, microvascular
permeability, and leukocyte-endothelial cell interaction of the host tissue were analyzed over 2 weeks
using intravital fluorescence microscopy. Ostim exhibited good biocompatibility comparable to that of
Cerabone and cancellous bone, as indicated by a lack of venular leukocyte activation after implantation.
Cancellous bone induced a more pronounced angiogenic response and an increased microvessel density
when compared with the synthetic bone substitutes. In contrast to Cerabone, however, Ostim showed a
guided neovascularization directed toward areas of degradation. Histology confirmed the ingrowth of
proliferating vascularized tissue into the hydroxyapatite paste at sites of degradation, while the
hydroxyapatite ceramic was not pierced by new microvessels. Thus, Ostim represents an injectable
synthetic bone substitute, which may optimize the conditions for the formation of new bone at sites of
bone defects by supporting a guided vascularization during biodegradation.
Orthopedic Studies
Void filling of tibia compression fracture zones using a novel resorbable nanocrystalline
hydroxyapatite paste in combination with a hydroxyapatite ceramic core: first clinical results.
Huber FX, McArthur N, Hillmeier J, Kock HJ, Baier M, Diwo M, Berger I, Meeder PJ. Arch Orthop Trauma
Surg. 2006 Oct;126(8):533-40. Epub 2006 Jul 12.
Abstract
INTRODUCTION:
It is a generally accepted standard surgical practice to fill-in the metaphyseal defect zones resulting from
the reduction of tibia compression fractures. The development of various innovative bone substitutes is
also currently on the increase.
MATERIALS AND METHODS:
In our prospective study, we used Ostim, a novel resorbable nanocrystalline hydroxyapatite paste,
together with Cerabone, a solid hydroxyapatite ceramic, in combination with angularly stable
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osteosynthesis to treat 24 tibia compression fractures. Types B2 and B3, as well as types C2 and C3
fractures, according to the AO classification, were included in the study.
RESULTS:
The mean total range of joint motion in terms of flexion and extension was improved from the
immediate postoperative value of 79 +/- 14 degrees to 97 +/- 13 degrees at 6 weeks after surgery, to 109
+/- 16 degrees at 3 months, and finally to 118 +/- 17 degrees at 1 year. In three patients, a delayed
wound healing was observed as a local complication.
CONCLUSION:
The use of the Ostim and Cerabone combination is an effective method in treating tibia compression
fractures with large defect zones left after reduction.
Review on injectable bone graft substitutes
Design of ceramic-based cements and putties for bone graft substitution
Marc Bohner. European Cells and Materials, Vol 20, 2010 (pages 1-12)
Abstract:
In the last 15 years, a large number of commercial ceramicbased cements and putties have been
introduced as bone graft substitutes. As a result, large efforts have been made to improve our
understanding of the specific properties of these materials, such as injectability, cohesion, setting time
(for cements), and in vivo properties. The aim of this manuscript is to summarize our present knowledge
in the field. Instead of just looking at scientific aspects, industrial needs are also considered, including
mixing and delivery, sterilization, and shelf-life.
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