Catalog DEXABONE Material de Aditie Osoasa de Origine Bovina

8/8/2019 Catalog DEXABONE Material de Aditie Osoasa de Origine Bovina

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Beauty comes from w ithin. Stability too.

Clinical routine shows that stability plays an important role during the early stages of implantology

treatment. The quicker and more intensive the osseointegration process, the higher the implant stability. Dexabone

is an incomparably stable, highly purified, and well established spongiosa bone graft material of bovine origin. It

goes further towards satisfying the requirements for increased safety and better predictability. The material is used

for oral guided bone regeneration (GBR) in the management of simple and complicated defects to build up the bonebed. The mineral composition, the crystalline structure, and the spongiosa structure of Dexabone are very similar to

those in the human body. Therefore, Dexabone achieves the same elasticity, strength and stability in the patient’s

jaw after integration as the body’s own jaw bone.

Dexabone is eminently suitable for all augmentation techniques for building up a strong implant bed and

treating periodontal defects. Dexabone is the material of choice for functional and aesthetic reconstructions for

natural, reliable, simple and economic bone regeneration. In combination with autologous bone and other bone graft

materials as well. Thanks to the particularly high degree of purity of the hydroxyapatite of bovine origin and the

physiological pH of 8.2, the outstanding homogeneity of the hydroxyapatite structure and the interconnecting

macropores of the natural bone, Dexabone is superior to other hydroxyapatite ceramics.

Table:

Mechanical properties of Dexabone

Stability with Dexabone

Mechanical properties Dexabone block

20x20x40mm3

Dexabone block

20x20x40mm3

Compressive force [N] 1670 +/ - 120 4510 +/ - 770

Compressive strength [N/cm2] 420 +/ - 32 564 +/ - 96

Shear force [N/cm2] 124 +/ - 35 338 +/ - 200

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Perfection is rare. Purity too.

The development of a single-phase hydroxyapatite such as Dexabone was prompted by the trend towards

increased safety and better predictability. The focus on the body’s biological healing processes demanded a material

that does not contaminate the healing process in the body with phase impurities. The phase content of Dexabone as

measured by X-ray diffractograms shows phase pure hydroxyapatite. Dexabone is pure and 100% safe (BSE) and

100% protein-free. Thus Dexabone does not contain any phase constituents that impair the healing process. Thismeans better clinical safety for therapist and patient alike. In this way, Dexabone exploits the natural and perfect

healing potential of the human body right from the start.

Diffraction pattern of natural bone; Dexabone; HA of algae and Tricalcium phosphate

Scanning electron microscope pictures

A natural bone DexaboneB

C DHA of algae TCP




Therapies need acceptance. Performance too.

Dexabone – Biofunctionality

The excellent acceptance and biocompatibility of hydroxyapatite and Dexabone spring from its material

properties. The other properties of Dexabone are based on the open interconnecting pore structure. This is identical

to the biological characteristics of the bovine starting material and arises from the physiological structure of the

human body. Dexabone’s macroporous structure is ideal in its osteoconductive function and promotes the ingrowth

of blood vessels and nerves. The adhesion and spread of osteoblasts over the Dexabone surface creates an open,

interconnecting pore structure, which prompts a bioactive reaction with bone tissue formation, bone tissue

strengthening and bone tissue interlinking leading to the restoration of the bone and its function. The

osteoconductive properties of hydroxyapatite ceramic have been demonstrated without doubt by biopsies.

Dexabone – Long-term success

The very good acceptance of Dexabone is seen in its efficacy. Hydroxyapatite of bovine origin has been

successfully used in clinical medicine since 1989. Radiological follow-ups after 3 and 6 months showed

consolidation of the defects that was consistent with the healing phase. Biopsies retrieved from clinical grafts

showed that the ceramic had almost completely been surrounded by bone and that newly formed bone had also been

deposited inside the ceramic pores. The long-term results were also confirmed by a large number of studies and

clinical applications.

Dexabone – Tolerability

The bone graft material Dexabone is extremely well tolerated. Its pH of 8.2 matches the physiological levels,

which is particularly important during the early stages of implantation. Dexabone does not contain any

pharmacologically active constituents. Large patient populations have confirmed the good biocompatibility of

hydroxyapatite ceramic. Not one single rejection reaction has been reported to date.

Dexabone – Administration

The Dexabone material is very hydrophilic and can easily be mixed with the patient’s blood before insertion.

The Dexabone/blood mixture demonstrates excellent coagulation properties and can be taken off the spatula

confidently and applied with pinpoint accuracy. Bone regeneration can be promoted in combination with autologous

blood and bone.

Dexabone is supplied in double sterile bottles ready for use :

Pack Sizes Granule Sizes

0.5 gr 0.5 – 1.0 mm / 1.0 – 2.0 mm

1.0 gr 0.5 – 1.0 mm / 1.0 – 2.0 mm

3.0 gr 0.5 – 1.0 mm / 1.0 – 2.0 mm

5.0 gr 0.5 – 1.0 mm / 1.0 – 2.0 mm




Dexabone solubility

a

The good integrated HA-ceramic

fragments are visible macroscopically.

b

Staining with toluidin blue.

Well structured trabecular bone

with numerous osteoblasts on the

trabecular and ceramic surface




Clinical Cases

X-ray of dental cyst, maxilla lt. situation before Cystectomy situation after Cystectomy

defect augmentation utilizing

Dexabone


Dexabone & Hyprosorb membrane



Courtesy of prof.Dr.med.dent.N.Watted, Center for Dentistry & Esthetics

Lateral sinus window Application of HyprosorbMembrane by perforated

Situation of perforated sinusmembrane

Dexabone filling of the sinus Hyprosorb membrane before

sinus window closing

Situation after bilateral flap closure

Courtesy of Dr.med.dent.Ph.D. Fahim Atamni




Hyprosorb membrane

&Dexabone

x-ray dental cyst, maxilla lt. situation before Cystectomy

situation after Cystectomy defect augmentation utilizing


x-ray after bone augmentation

utilizing Dexabone



Clinical Cases



Efficacy makes sense. Safety too.

The clinical application of Dexabone guarantees the highest possible safety and predictability. The

spongiosa bone graft material of bovine origin Dexabone covers a broad spectrum of indications and offers so many

options for effective and safe prognoses in everyday clinical routine.

Dexabone is produced by a specially developed method under clean-room conditions using a validatedproduction process. aap Biomaterials GmbH & Co. KG satisfies the requirements of a quality management system

in accordance with EN ISO 13485:2003 and EN ISO 9001:2000. The product Dexabone fulfils the requirements

laid down in Annex II.4 of Directive 93/42/EEC and Directive 2003/32/EC.

Dexabone – Safety

The unique manufacturing process with a two-stage heating process removes unwanted fractions such as fat,

cells, antigen structures and inactivated pathogens. The specific retrieval of bovine donor spongiosa is the reason forthe balanced ratio of porosity and density of Dexabone and offers an incomparably firm bond between the ceramic

crystals and unique mechanical strength. The controlled further processing with wide-ranging chemical purification

processes and specific high-temperature stages inactivates all organic elements and eliminates all immunological

processes: Dexabone is 100% safe (BSE), 100% protein-free.

Dexabone is a hydroxyapatite ceramic that consists entirely of inorganic material which is available as

granules of various sizes or pre-formed shapes.

Dexabone is superior to other hydroxyapatite ceramics due to its particularly high degree of purity,

the physiological pH, the homogeneity of the hydroxyapatite structure and the interconnecting macropores.

Literature

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. 2007 Jun 14

Injectable nanocrystalline hydroxyapatite paste for bone substitution: in vivo analysis of biocompatibility and vascularization LaschkeMW, Witt K, Pohlemann T, Menger MD. J Biomed Mater Res B Appl Biomater. 2007 Aug;82(2):494-505

Void filling of tibia compression fracture zones using a novel resorbable nanocrystalline hydroxyapatite paste in combination with ahydroxyapatite 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

Treatment of dorsally displaced distal radius fractures with a double dorsal plate: a study of 12 patients

Fernandez Baca F, Benrahho J. Chir Main. 2006 Feb;25(1):27-32. French.

Biocompatibility testing of different sterilised or disinfected allogenous bone grafts in comparison to the gold standard of autologous bonegrafts--an "in vitro" analysis of immunomodulation

Endres S, Kratz M, Heinz M, Herzberger C, Reichel S, von Garrel T, Gotzen L, Wilke A. Z Orthop Ihre Grenzgeb. 2005 Nov-Dec;143(6):660-8. German.

Biomechanical assessment of bone ingrowth in porous hydroxyapatite Hing KA, Best SM, Tanner KE, Bonfield W, Revell PA. J Mater SciMater Med. 1997 Dec;8(12):731-6.

Characterization of porous hydroxyapatite Hing KA, Best SM, Bonfield W J Mater Sci Mater Med. 1999 Mar;10(3):135-45.



Mechanical failure of porous hydroxyapatite ceramics 7.5 years after implantation in the proximal tibial Linhart W, Briem D, Amling M,Rueger JM, Windolf J. Unfallchirurg. 2004 Feb;107(2):154-7. German.

Mediation of bone ingrowth in porous hydroxyapatite bone graft substitutes Hing KA, Best SM, Tanner KE, Bonfield W, Revell PA. J

Biomed Mater Res A. 2004 Jan 1;68(1):187-200.

Arthroscopic management of tibial plateau fractures Attmanspacher W, Dittrich V, Staiger M, Stedtfeld HW. Zentralbl Chir. 2002

Oct;127(10):828-36. German.

Bone substitutes as carriers for transforming growth factor-beta(1) (TGF-beta(1)) Gille J, Dorn B, Kekow J, Bruns J, Behrens P. Int Orthop.

2002;26(4):203-6. Epub 2002 Apr 23.

Long-term outcomes after using porous hydroxyapatite ceramics (Endobon) for surgical management of fractures of the head of the tibiaBriem D, Linhart W, Lehmann W, Meenen NM, Rueger JM. Unfallchirurg. 2002 Feb;105(2):128-33. German.

Osseous integration of hydroxyapatite grafts in metaphyseal bone defects of the proximal tibia (CT-study) Khodadadyan-Klostermann C,Liebig T, Melcher I, Raschke M, Haas NP. Acta Chir Orthop Traumatol Cech. 2002;69(1):16-21.

Madreporic hydroxyapatite granulates for filling bone defects Müller-Mai C, Voigt C, Hering A, Rahmanzadeh R, Gross U. Unfallchirurg.2001 Mar;104(3):221-9. German.

Evaluation of hydroxyapatite implants in vertebral bodies and extremities by contrast-enhanced magnetic resonance imaging Grimm J,Mueller-Huelsbeck S, Mueller M, Egbers HJ, Brinkmann G, Heller M. Arch Orthop Trauma Surg. 2001;121(3):158-61.

Osseous integration of bovine hydroxyapatite ceramic in metaphyseal bone defects of the distal radius Werber KD, Brauer RB, Weiss W,

Becker K. J Hand Surg [Am]. 2000 Sep;25(5):833-41.

Metaphyseal defect substitute: hydroxylapatite ceramic. Results of a 3 to 4 year follow up Helber MU, Ulrich C. Unfallchirurg. 2000

Sep;103(9):749-53. German

Fractures of the distal forearm. Which therapy is indicated when? Brug E, Joosten U, Püllen M. Orthopade. 2000 Apr;29(4):318-26.German.

Various evaluation techniques of newly formed bone in porous hydroxyapatite loaded with human bone marrow cells implanted in anextra-osseous site Bareille R, Lafage-Proust MH, Faucheux C, Laroche N, Wenz R, Dard M, Amédée J. Biomaterials. 2000Jul;21(13):1345-52.

Reactions and complications after the implantation of Endobon including morphological examination of explants Gierse H, Donath K.Arch Orthop Trauma Surg. 1999;119(5-6):349-55.

Defect reconstruction using demineralized bone matrix. Experimental studies on piglets Schnettler R, Dingeldein E, Herr G. Orthopade.

1998 Feb;27(2):80-8. German.

Hydroxyapatite ceramics in clinical application. Histological findings in 23 patients Liebendörfer A, Tröster S. Unfallchirurgie. 1997

Apr;23(2):60-8. German.

Ectopic bone formation with the help of growth factor bFGF Wiltfang J, Merten HA, Wiltfang J. J Craniomaxillofac Surg. 1996Oct;24(5):300-4.

Tissue reaction and material characteristics of four bone substitutes Jensen SS, Aaboe M, Pinholt EM, Hjørting-Hansen E, Melsen F,Ruyter IE. Int J Oral Maxillofac Implants. 1996 Jan-Feb;11(1):55-66.


Catalog DEXABONE Material de Aditie Osoasa de Origine Bovina

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