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

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.

Acta of Bioengineering and Biomechanics

2012

Vol. 14, no. 1

39-44

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.

Ocena własności fizycznych i biologicznych samoorganizującego się biomateriału otrzymanego z chitozanu/fosforanu wapnia/alginianu do zastosowań stomatologicznych

Kucharska M., Bubak G., Kowalczyk M., Bojar W., Brynk T., Koperski Ł., Ciach T.

Engineering of Biomaterials

2011

Vol. 14, no. 105

20-24

Celem niniejszej pracy było zaprojektowanie i otrzymanie wstrzykiwalnego biomateriału o własnościach osteokondukcyjnych, który potencjalnie mógłby znaleźć zastosowanie w procesach augmentacji kości przed leczeniem implantologicznym z wykorzystaniem sterowanej regeneracji kości (GBR). W tym celu opracowano samoorganizujący się biomateriał otrzymany z granulatu chitozan/fosforan trójwapnia oraz soli sodowej kwasu alginowego (CH/TCP/Alg). Opracowany materiał przebadano pod względem morfologii i mikrostruktury, zarówno granulatu, jak i uformowanych aglomeratów. Własności fizyczne, takie jak czas żelowania oraz wytrzymałość mechaniczna na ściskanie były przedmiotem niniejszych badań. Przeprowadzono także testy in vivo opracowanego biomateriału na modelu szczura. Dokonano oceny odpowiedzi modelu zwierzęcego na zaimplantowany biomateriał, a wyniki porównano z alloplastycznym materiałem komercyjnie dostępnym. Otrzymane wyniki wskazały, że opracowany wstrzykiwalny system spełnia wymagania pod kątem zastosowań w sterowanej regeneracji kości.

The main objective of the work was to design and fabricate an injectable biomaterial with osteoconductive properties for bone augmentation and potential to be used in dental applications in peri-implant therapy concerning guided bone regeneration. For this purpose, a self-setting biomaterial consisting of chitosan/ tricalcium phosphate microparticles and sodium alginate was formulated (CH/TCP/Alg). The obtained material was characterized as far as microsphere and formed agglomerates morphology and microstructure. Physical properties relating to setting time and mechanical properties were also investigated. Finally, in vivo response to implanted biomaterial was studied on rat model and compared with commercially available alloplastic material. The obtained results showed that designed injectable biomaterial fulfilled main requirements for guided bone regeneration application.

Preparation of chitosan/calcium phosphate based injectable system for guided bone regeneration and its properties investigation

Bubak G., Kowalczyk M., Brynk T., Bojar W., Kucharska M., Ciach T.

Challenges of Modern Technology

2011

Vol. 2, no. 4

21--26

The main objective of the work was to design and fabricate an injectable biomaterial with osteoconductive properties that can be used in dental applications in peri-implant therapy concerning guided bone regeneration. For that purpose, a self-setting biomaterial consisting of chitosan/tricalcium phosphate microparticles and sodium alginate was formulated. The obtained material was characterized regarding microsphere and formed agglomerates morphology and microstructure. Physical properties, relating to setting time and mechanical properties, were also investigated. Finally, in vivo response to implanted biomaterial was studied on a rat model and compared with commercially available alloplastic material. The results showed that designed injectable biomaterial fulfi lled main requirements for guided bone regeneration application.