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Process development of a virally-safe dental xenograft material from porcine bones
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 Title & Authors
Process development of a virally-safe dental xenograft material from porcine bones
Kim, Dong-Myong; Kang, Ho-Chang; Cha, Hyung-Joon; Bae, Jung Eun; Kim, In Seop;
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 Abstract
A process for manufacturing virally-safe porcine bone hydroxyapatite (HA) has been developed to serve as advanced xenograft material for dental applications. Porcine bone pieces were defatted with successive treatments of 30% hydrogen peroxide and 80% ethyl alcohol. The defatted porcine bone pieces were heat-treated in an oxygen atmosphere box furnace at to remove collagen and organic compounds. The bone pieces were ground with a grinder and then the bone powder was sterilized by gamma irradiation. Morphological characteristics such as SEM (Scanning Electron Microscopy) and TEM (Transmission Electron Microscopy) images of the resulting porcine bone HA (THE Graft) were similar to those of a commercial bovine bone HA (Bio-Oss). In order to evaluate the efficacy of heat treatment and gamma irradiation at a dose of 25 kGy for the inactivation of porcine viruses during the manufacture of porcine bone HA, a variety of experimental porcine viruses including transmissible gastroenteritis virus (TGEV), pseudorabies virus (PRV), porcine rotavirus (PRoV), and porcine parvovirus (PPV) were chosen. TGEV, PRV, PRoV, and PPV were completely inactivated to undetectable levels during the heat treatment. The mean log reduction factors achieved were for TGEV, for PRV, for PRoV, and for PPV. Gamma irradiation was also very effective at inactivating the viruses. TGEV, PRV, PRoV, and PPV were completely inactivated to undetectable levels during the gamma irradiation. The mean log reduction factors achieved were for TGEV, for PRV, for PRoV, and for PPV. The cumulative log reduction factors achieved using the two different virus inactivation processes were for TGEV, for PRV, for PRoV, and for PPV. These results indicate that the manufacturing process for porcine bone HA from porcine-bone material has sufficient virus-reducing capacity to achieve a high margin of virus safety.
 Keywords
dental xenograft material;hydroxyapatite;porcine bone;porcine pathogenic viruses;virus inactivation;
 Language
English
 Cited by
 References
1.
Accorsi-Mendonca, T., Conz, M.B., Barros, T.C., de Sena, L.A., Soares, G.A., and Granjeiro, J.M. 2008. Physicochemical characterization of two deproteinized bovine xenografts. Braz. Oral Rres. 22, 5-10. crossref(new window)

2.
Bae, J.E., Kim, C.K., Kim, S., Yanf, E.K., and Kim, I.S. 2012. Virus inactivation during the manufacture of a collagen type I from bovine hides. Korean J. Microbiol. 48, 314-318. crossref(new window)

3.
Bae, J.E., Kim, C.K., Kim, S., Yang, E.K., and Kim, I.S. 2010. Process development of a virally-safe acellular bovine amniotic membrane for biological dressing. Korean J. Microbiol. Biotechnol. 38, 420-427.

4.
Bauer, T.W. and Muschler, G.F. 2000. Bone graft materials: an overview of the basic science. Clin. Orthop. Relat. Res. 371, 10-27. crossref(new window)

5.
Concannon, M.J., Boschert, M.T., and Puckett, C.L. 1997. Bone induction using demineralized bone in the rabbit femur: A longterm study. Plast. Reconstr. Surg. 99, 1983-1988. crossref(new window)

6.
Damien, C.J. and Parsons, J.R. 1991. Bone graft and bone graft substitutes: a review of current technology and applications. J. Appl. Biomater. 2, 187-208. crossref(new window)

7.
Ducheyne, P.E. and Qiu, Q. 1999. Bioactive ceramics: the effect of surface reactivity on bone formation and bone cell function. Biomaterials 20, 2287-2303. crossref(new window)

8.
Forest, P., Morfin, F., Bergeron, E., Dore, J., Bensa, S., Wittmann, C., Picot, S., Renaud, F.N., Freney, J., and Gagnieu, C. 2007. Validation of a viral and bacterial inactivation step during the extraction and purification process of porcine collagen. Biomed. Mater. Eng. 17, 199-208.

9.
Haas, R., Mailath, G., Dortbudak, O., and Watzek, G. 1998. Bovine hydroxyapatite for maxillary sinus augmentation: analysis of interfacial bond strength of dental implants using pull-out tests. Clin. Oral Implant Res. 9, 117-122. crossref(new window)

10.
Hallman, M. and Thor, A. 2008. Bone substitutes and growth factors as an alternative/complement to autogenous bone for grafting in implant dentistry. Periodontology 2000 47, 172-192. crossref(new window)

11.
Hodde, J. and Hiles, M. 2002. Virus safety of a porcine-derived medical device: evaluation of a viral inactivation method. Biotechnol. Bioeng. 79, 211-216. crossref(new window)

12.
International Conference on Harmonisation. 1998. Guidance on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. Federal Resister 63, 51074-51084.

13.
International Organization for Standardization. 2006. ISO 11137-2: 2006. Sterilization of health care products - radiation -- Part 2: Establishing the sterilization dose. Geneva, Switzerland.

14.
International Organization for Standardization. 2007. Medical devices utilizing animal tissues and their derivatives-Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agent. Geneva, Switzerland.

15.
Jensen, S.S., Bosshardt, D.D., and Buser, D. 2009. Bone grafts and bone substitute materials, pp. 1-96. In Buser, D. (ed.), 20 Years of Guided Bone Regeneration in Implant Dentistry: Quintessence Publishing, Chicago, USA.

16.
Karber, J. 1931. Beitrag zur kollectiven Behandlung pharmakologische Reihenversuche. Arch. Exp. Path. Pharmak. 162, 480-483. crossref(new window)

17.
Khan, S.N., Cammisa, F.P.Jr., Sandhu, H.S., Diwan, A.D., Giradi, F.P., and Lane, J.M. 2005. The biology of bone grafting. J. Am. Acad. Orthop. Surg. 13, 77-86. crossref(new window)

18.
Kim, D.M., Kim, H.J., Kang, H.C., Kim, H.S., Kim, D.H., Kim, K.I., Yun, S.Y., Han, K.H., Kim, J.Y., and Lee, J.H. 2014a. A method for preparing a porcine bone graft with an excellent performance in cell adhesion and bone formation using nano hydroxyapatite surface modification technology, and a porcine bone graft prepared thereby, Kor. Patent. No. 10-2014-0052399: 1-30.

19.
Kim, D.M., Kim, H.J., Kang, H.C., Kim, H.S., and Lee, J.H. 2014b. Method of funtionalize surface of bone graft with bone nano particle and bone graft having funtionalized surface by bone nano particle, Kor. Patent. No. 10-2014-0078335: 1-28.

20.
Kim, Y., Rodriguez, A.E., and Nowzari, H. 2016. The risk of prion infection through bovine grafting materials. Clin. Implant Dent. Relat. Res. DOI 10.1111/cid.12391. crossref(new window)

21.
Park, J.W., Ko, H.J., Jang, J.H., Kang, H., and Suh, J.Y. 2012. Increased new bone formation with a surface magnesiumincorporated deproteinized porcine bone substitute in rabbit calvarial defects. J. Biomed. Mater. Res. 100, 834-840.

22.
Pinholt, E.M., Bang, G., and Haanaes, H.R. 1991. Alveolar ridge augmentation in rats by Bio-Oss. Scand. J. Dent. Res. 99, 154-161.

23.
Valimaki, V.V. and Aro, H.T. 2006. Molecular basis for action of bioactive glasses as bone graft substitute. Scand. J. Surg. 95, 95-102. crossref(new window)

24.
Venkataraman, N., Bansal, S., Bansal, P., and Narayan, S. 2015. Dynamics of bone graft healing around implants. J. ICDRO 7, 40-47.

25.
Yoo, K.H., Shim, K.M., Park, H.J., and Choi, S.H. 2010. Effect of porcine cancellous bones on regeneration in rats with calvarial defect. J. Life Sci. 20, 1207-1213. crossref(new window)