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Dexabone® made by : aap Biomaterials GmbH & Co. KG , GermanyCancellous bone graft material of bovine originGuarantees the highest possible safety and predictabilityDEXABONE® este disponibil in granule de diferite dimensiuni : Cantitate : 0,5gr ; 1gr ; 3gr ; 5gr ; Granulatie mica : 0,5 - 1.0mm ; Granulatie mare : 1.0 - 2.0mm ; DEXABONE este un material de substitutie osoasa de origine bovina (spongioasa) a carui structura interna este identica cu cea a osului uman. DEXABONE dispune de o stabilitate initiala excelenta, iar in timpul osteointegrarii obtine aceasi elasticitate, forta si stabilitate cu cea a osului gazda. DEXABONE® este disponibil in granule de diferite dimensiuni : Cantitate : 0,5gr ; 1gr ; 3gr ; 5gr ; Granulatie mica : 0,5 - 1.0mm ; Granulatie mare : 1.0 - 2.0mm ; DEXABONE este un material de substitutie osoasa de origine bovina (spongioasa) a carui structura interna este identica cu cea a osului uman. DEXABONE dispune de o stabilitate initiala excelenta, iar in timpul osteointegrarii obtine aceasi elasticitate, forta si stabilitate cu cea a osului gazda. Procedeul tehnologic prin care se trateaza osul bovin pentru indepartarea partilor organice este acela de sinterizare la temperatura inalta (1300°C). Asfel, DEXABONE este un produs de origine bovina 100% , fara a contine proteine, apa sau alti compusi organici. Continutul DEXABONE masurat prin difractie in raze X arata ca acesta nu contine impuritati . Structura macroporoasa a DEXABONE este ideala in functia sa osteoconductiva si suporta cresterea interna a vaselor de sange si a nervilor. Adeziunea si raspandirea osteoblastelor pe suprafata DEXABONE formeaza o structura deschisa de pori interconectati care genereaza o reactie bioactiva insotita de for¬marea, intarirea si interconectarea tesutului osos care duce la restaurarea osului si a functiilor sale. Proprietatile osteoconductive ale DEXABONE au fost demonstrate fara de indoiala de biopsii . Substituentul osos DEXABONE este extrem de bine tolerat. Ph-ul sau de 8.2 este apropiat de nivelele fiziologice, ceea ce este deosebit de important in primele faze ale implantarii. DEXABONE este un substituent osos de origine bovina ce consta in intregime din material anorganic si are ca forma de prezentare granule de diferite marimi si in volume diferite. DEXABONE este superior altor substituenti datorita gradului sau mare de puritate, Ph-ului fiziologic, omogenitatii structurii acestuia si a macroporilor interconectati. Substituentul osos spongios de origine bovina DEXABONE acopera un spectru larg de indicatii si ofera foarte multe optiuni pentru tratarea eficienta si prognozarea sigura a cazurilor zilnice. Beneficii • Granule de os mineral natural de origine bovina • Osteoconductiv • Structura spongiosa cu macropori interconectati • Stabilitate mecanica inalta • Datorita granulatiei diferite, se poate utiliza in orice situatie • Osteointegrare ridicata • Eficacitate dovedita de studii clinice Indicatii : Implantologie: augmentare osoasa pentru implantare simultana / ulterioara, sinus lift inchis/deschis, augmentare osoasa in zona alveolara. Parodontologie: defecte intraosoase Chirurgie: augmentarea alveolelor post extractionale DEXABONE este produs dupa o metoda speciala si in mediu steril folosind un proces de pro-ductie verificat si aprobat. Aap Biomaterials GmBH&Co. KG intruneste cerintele de manage¬ment al calitatii in concordanta cu certificarile EN ISO 13845:2003 si EN ISO 9001:2000. Produ¬sul DEXABONE intruneste cerintele trecute in anexa II .4 a directivelor 93/42/EEC si 2003/32/EC.Date de contact : ARDS Implant Mobil : +4 0722 750 218 [email protected]
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Mobil : +4 0722 750 218 ;Tel/Fax : +4 021 310 27 67 ; E-mail : [email protected]
Beauty comes from within. 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 bone bed. 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
Mobil : +4 0722 750 218 ;Tel/Fax : +4 021 310 27 67 ; E-mail : [email protected]
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. This means 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 Dexabone B
C D HA of algae TCP
Mobil : +4 0722 750 218 ;Tel/Fax : +4 021 310 27 67 ; E-mail : [email protected]
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
Mobil : +4 0722 750 218 ;Tel/Fax : +4 021 310 27 67 ; E-mail : [email protected]
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
Mobil : +4 0722 750 218 ;Tel/Fax : +4 021 310 27 67 ; E-mail : [email protected]
Clinical Cases
X-ray of dental cyst, maxilla lt. situation before Cystectomy situation after Cystectomy
defect augmentation utilizing Dexabone
defect augmentation utilizing Dexabone & Hyprosorb membrane
defect augmentation utilizing Dexabone & Hyprosorb membrane
Courtesy of prof.Dr.med.dent.N.Watted, Center for Dentistry & Esthetics
Lateral sinus window Application of Hyprosorb Membrane by perforated
Situation of perforated sinus membrane
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
Dexabone & Hyprosorb membrane
x-ray after bone augmentation utilizing Dexabone
Courtesy of prof.Dr.med.dent.N.Watted, Center for Dentistry & Esthetics
Courtesy of prof.Dr.med.dent.N.Watted, Center for Dentistry & Esthetics
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 validated production 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 for the 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.
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