Formation and preclinical evaluation of a new alloplastic injectable bone substitute material

• Autorzy: Bojar W. , Kucharska M. , Bubak G. , Ciach T. , Koperski Ł. , Jastrzębski Z. , Gruber B.M. , Krzysztoń-Russjan J. , Marczewska J. , Anuszewska E. , Drozd E. , Brynk T.
• Języki publikacji: EN

Abstrakty

EN

Alloplastic bone substitute materials are raising some more interest as an alternative for autologic transplants and xenogenic materials especially in oral surgery over the last few years. These non-immunogenic and completely resorbable biomaterials are the basis for complete and predictable guided bone regeneration. In the majority of cases, such a material is chosen because of its convenient application by surgeons. The main objective of our project was to design and fabricate an osteoconductive, injectable and readily tolerable by human tissues biomaterial for guided bone regeneration. For this purpose, a self-setting composite consisting of chitosan/tricalcium phosphate microparticles and sodium alginate was made. The material obtained was characterized by microsphere and agglomerate morphology and microstructure. Its features relating to setting time and mechanical properties were precisely investigated. Our material was also evaluated according to PN-EN ISO 10993 Biological evaluation of medical devices, i.e., the in vitro tests for genotoxicity and cytotoxicity were conduced. Then, the following examinations were performed: subchronic systemic toxicity, skin sensitization, irritation and delayed-type hypersensitivity and local effects after implantation. The material tested showed a high degree of cytocompatibility, fulfilled the requirements of International Standards and seemed to be a "user friendly" material for oral surgeons.

Słowa kluczowe

EN

alginate; bone substitute material; chitosan; guided bone regeneration; beta-tricalcium phosphate

• Wydawca: Oficyna Wydawnicza Politechniki Wrocławskiej
• Czasopismo: Acta of Bioengineering and Biomechanics
• Rocznik: 2012
• Tom: Vol. 14, no. 1
• Strony: 39--44
• Opis fizyczny: Bibliogr. 8 poz., rys.

Twórcy

autor

Bojar W.

autor

Kucharska M.

autor

Bubak G.

autor

Ciach T.

autor

Koperski Ł.

autor

Jastrzębski Z.

autor

Gruber B.M.

autor

Krzysztoń-Russjan J.

autor

Marczewska J.

autor

Anuszewska E.

autor

Drozd E.

autor

Brynk T.

• Medical Devices Department, National Medicines Institute, Warsaw,

Bibliografia

• [1] HOROVITZ R.A., MAZOR Z., FOITZIK C., PRASAD H., ROHRER M., PTIAL A., β-tricalcium phosphate as bone substitute material: properties and clinical applications, Titanium, 2009, 1, 2, 1–11.
• [2] AUGST A.D., KONG H.J., MOONEY D.J., Alginate hydrogels as biomaterials, Macromol. Biosci., 2006, 623–633.
• [3] ZHENSHENG L., HASSNA R., RAMAYA, KIP D., HAUCHB, DEMIN XIAOC, MIQIN ZHANGA, Chitosan-alginate hybrid scaffolds for bone tissue engineering, Biomaterials, 2005, 26(18), 3919–1928.
• [4] HSU S., WHU S.W., TSAI C.L., WU Y.H., CHEN H.W., HSIEH K.H., Chitosan as scaffold materials: effects of molecular weight and degree of deacetylation, J. Polym. Res., 2004, 11(2), 141–147.
• [5] KIM I.Y., SEO S.J., MOON H.S., YOO M.K., PARK I.Y., KIM B.C., CHO C.S., Chitosan and its derivatives for tissue engineering applications, Biotechnol. Adv., 2008, 26(1), 1–21.
• [6] KHOR E., LIM L.Y., Implantable applications of chitin and chitosan, Biomaterials, 2003, 24(13), 2339–2349.
• [7] RAVI KUMAR M.N.V., MUZZARELLI R.A.A. et al., Chitosan chemistry and pharmaceutical perspectives, Chem. Rev., 2004, 104, 12, 6017–6084.
• [8] BOJAR W., MARCZEWSKA J., ANUSZEWSKA E., KARWICKA E., Cytotoxicity and mutagenicity of N2 cement – root canal filling material, Adv. Clin. Exp. Med., 2009, 18, 6, 615–621.