Tissue Engineering and Regenerative Medicine

Korean Tissue Engineering and Regenerative Medicine Society (한국조직공학·재생의학회)
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The Effect of Gamma Radiation Sterilization on Dental Biomaterials

  • Turker, N. Selcan (Hacettepe University, Fac Pharmacy, Dep. Radiopharmacy. MGH-Harvard Medical School, Dep. Radiology) ;
  • Ozer, A. Yekta (Hacettepe University, Fac Pharmacy, Dep. Radiopharmacy) ;
  • Kutlu, Burak (Hacettepe University, Fac Dentistry, Dep. Periodontology) ;
  • Nohutcu, Rahime (Hacettepe University, Fac Dentistry, Dep. Periodontology) ;
  • Sungur, Arzu (Hacettepe University, Fac Medicine, Department of Pathology) ;
  • Bilgili, Hasan (Ankara University, Faculty of Veterinary Medicine, Department of Orthopaedics and Traumatology) ;
  • Ekizoglu, Melike (Hacettepe University, Fac Pharmacy, Department of Microbiology) ;
  • Ozalp, Meral (Hacettepe University, Fac Pharmacy, Department of Microbiology)
  • Received : 2014.03.17
  • Accepted : 2014.05.29
  • Published : 2014.10.01
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Abstract

Biomaterials are used in the field of bone and tissue engineering, orthopaedics and dentistry. Dental biomaterials including commercially available biodegradable materials act as physical barriers to help quicker healing while stimulating the regeneration of periodontal tissues, which is defined as Guided Tissue Regeneration (GTR). Amongst natural and synthetic biomaterials, collagen and aliphatic polyesters, such as polylactic acid (PLA) and poly (lactic-co-glycolic) acid (PLGA) are the most frequently used biomaterials for regenerative therapies due to their excellent biocompatibility and biodegradability. Due to their resorption in the body and interaction with biological systems, the GTR membranes must be sterile and pyrogen free. The sterility and apyrogenicity of the GTR membranes before human use is a regulatory requirement, however the sterilization of biomaterials is challenging due to the physicochemical changes and toxic residues with the commonly used sterilization techniques. The purpose of the present study was to evaluate the effect of gamma radiation and ethylene oxide sterilization on dental biomaterials with analytical, microbiological and histological examinations. PLGA-based GTR dental biomaterial is selected as the most gamma stable membrane according to the FTIR, DSC, TGA, and SEM results. This dental membrane was sterilized with ethylene oxide (EtO) and the effect of sterilization method on PLGA-based membrane was also investigated. Animal experiments were carried out to evaluate the regenerative properties and inflammatory responses of gamma and EtO sterilized PLGA-based GTR membrane after implantation. Histological examinations showed that resorption and bone formation of gamma sterilized PLGA-based GTR membrane was completed in 12 weeks without any inflammatory response; while only $60.095{\pm}2.019%$ of new bone formation was observed with EtO sterilized one. Gamma sterilized PLGA membrane had significantly faster (P < 0.05) resorption and bone formation in comparison with EtO sterilization. In conclusion, the PLGA-based biomaterials could be sterilized safely and time- and cost-effectively with validated radiation doses for the tissue engineering applications.

Keywords

References

  1. MC Bottino, V Thomas, G Schmidt, et al., Recent advances in the development of GTR/GBR membranes for periodontal regeneration--a materials perspective, Dent Mater, 28, 703 (2012). https://doi.org/10.1016/j.dental.2012.04.022
  2. T Guda, JA Walker, BM Singleton, et al., Guided bone regeneration in long-bone defects with a structural hydroxyapatite graft and collagen membrane, Tissue Eng. Part A, 19, 1879 (2013). https://doi.org/10.1089/ten.tea.2012.0057
  3. L Shue, Z Yufeng, U Mony, Biomaterials for periodontal regeneration: a review of ceramics and polymers, Biomatter, 2, 27 (2012).
  4. C Xu, C Lei, L Meng, C Wang, Y Song, Chitosan as a barrier membrane material in periodontal tissue regeneration. J Biomed Mater Res B Appl Biomater, 100, 1435 (2012).
  5. A Ramseier, C Siethoff, J Caslavska, W Thormann, Confirmation testing of amphetamines and designer drugs in human urine by capillary electrophoresis-ion trap mass spectrometry, Electrophoresis, 21, 380 (2000). https://doi.org/10.1002/(SICI)1522-2683(20000101)21:2<380::AID-ELPS380>3.0.CO;2-L
  6. NG Sahoo, YZ Pan, L Li, CB He, Nanocomposites for bone tissue regeneration, Nanomedicine, 8, 639 (2013). https://doi.org/10.2217/nnm.13.44
  7. A Sculean, D Nikolidakis, F Schwarz, Regeneration of periodontal tissues: combinations of barrier membranes and grafting materials - biological foundation and preclinical evidence: a systematic review, J Clinical Periodontol, 35, 106 (2008). https://doi.org/10.1111/j.1600-051X.2008.01263.x
  8. RE Jung, V Kokovic, M Jurisic, D Yaman, K Subramani, FE Weber, Guided bone regeneration with a synthetic biodegradable membrane: a comparative study in dogs, Clin Oral Implants Res, 22, 802 (2011). https://doi.org/10.1111/j.1600-0501.2010.02068.x
  9. JS Son, SG Kim, SC Jin, et al., Development and structure of a novel barrier membrane composed of drug-loaded poly(lactic-coglycolic acid) particles for guided bone regeneration, Biotechnol Lett, 34, 779 (2012). https://doi.org/10.1007/s10529-011-0819-x
  10. B Jiang, Z Wu, H Zhao, et al., Electron beam irradiation modification of collagen membrane, Biomaterials, 27, 15 (2006). https://doi.org/10.1016/j.biomaterials.2005.05.091
  11. J Li, J Yang, X Zhong, F He, X Wu, G Shen, Demineralized dentin matrix composite collagen material for bone tissue regeneration, J Biomater Sci Poly ed., 24, 1519 (2013). https://doi.org/10.1080/09205063.2013.777227
  12. S Kim, KC Oh, DH Han, SJ Heo, IC Ryu, JH Kwon, CH Han, Influence of transmucosal designs of dental implant on tissue regeneration in beagle dogs, Int J Oral Maxillofac Implants, 25, 309 (2010).
  13. KG Cornwell, A Landsman, KS James, Extracellular matrix biomaterials for soft tissue repair, Clin Podiatr Med Surg, , 26, 507 (2009). https://doi.org/10.1016/j.cpm.2009.08.001
  14. NS Turker, AY Ozer, B Kutlu, R Nohutcu, H Bilgili, D Oztürk, M Ozalp, A Sungur, Gamma irradiation studies I. Dental Grafts, J Med Devices. 5, 031011, (2011). https://doi.org/10.1115/1.4004647
  15. IH Mohamed, Current perspectives of nanoparticles in medical and dental biomaterials, J Biomed Res, 26, 143 (2012).
  16. E Rohm-Rodowald, B Jakimiak, Assessment of the sterilization of medical devices--an important challenge to health care in Poland, Przegl Epidemiol, 58, 501 (2004).
  17. T Nieminen, I Kallela, J Keranen, et al., In vivo and in vitro degradation of a novel bioactive guided tissue regeneration membrane, Int J Oral Maxillofac Surg, 35, 727 (2006). https://doi.org/10.1016/j.ijom.2006.01.030
  18. SJ Khurshid, Bioburden and theoretical sterility dose calculation for radiation sterilization of surgical cotton and bandages, J Pak Med Assoc, 43, 8 (1993).
  19. W Ji, F Yang, J Ma, et al., Incorporation of stromal cell-derived factor-1alpha in PCL/gelatin electrospun membranes for guided bone regeneration, Biomaterials, 34, 735 (2013). https://doi.org/10.1016/j.biomaterials.2012.10.016
  20. BP Fairand, N Fidopiastis, Radiation sterilization of aseptically manufactured products, PDA J Pharm Sci Technol, 64, 299 (2010).
  21. JA Bushell, M Claybourn, HE Williams, DM Murphy, An EPR and ENDOR study of gamma- and beta-radiation sterilization in poly (lactide-co-glycolide) polymers and microspheres, Journal of controlled release, 110, 49 (2005). https://doi.org/10.1016/j.jconrel.2005.09.009
  22. CC Chen, JY Chueh, H Tseng, HM Huang, SY Lee, Preparation and characterization of biodegradable PLA polymeric blends, Biomaterials, 24, 1167 (2003). https://doi.org/10.1016/S0142-9612(02)00466-0
  23. GC Mendes, TR Brandao, CL Silva, Ethylene oxide sterilization of medical devices: a review, American journal of infection control, 35, 547 (2007).
  24. RM Brinston, BK Wilson, Converting to gamma-radiation sterilization: an overview for medical device manufacturers, Medical device technology, 4, 18 (1993).
  25. M Cignitti, Sterilization by gamma radiation of materials for pharmaceutical use: the problem of its effect on chemical structure, Boll Chim Farm, 131, 71 (1992).
  26. N Bitterman, Design of medical devices--a home perspective. Eur J Intern Med, 22, 39 (2011). https://doi.org/10.1016/j.ejim.2010.09.017
  27. M Guo, WT Rong, J Hou, et al., Mechanisms of chitosan-coated poly(lactic-co-glycolic acid) nanoparticles for improving oral absorption of 7-ethyl-10-hydroxycamptothecin, Nanotechnology, 244, 245101 (2013).
  28. JS Lee, TK An, GS Chae, et al., Evaluation of in vitro and in vivo antitumor activity of BCNU-loaded PLGA wafer against 9L gliosarcoma., Eur J Pharm Biopharm, 59, 169 (2005). https://doi.org/10.1016/j.ejpb.2004.06.006
  29. E Suljovrujiae, D Uskokoviae, M Mitrae, M Mitroviae, S Tomiae, Radiation-induced degradation of hydroxyapatite/poly L-lactide composite biomaterial, Rad Phys Chem, 76, 722, (2007). https://doi.org/10.1016/j.radphyschem.2006.02.013
  30. E Azorin, PR Gonzalez-Martinez, J Azorin, Collagen I confers gamma radiation resistance, Appl Radiat Isot, 71, 71 (2012). https://doi.org/10.1016/j.apradiso.2012.03.039
  31. OM Almeida, W Jorgetti, D Oksman, C Jorgetti, DL Rocha, R Gemperli, Comparative study and histomorphometric analysis of bone allografts lyophilized and sterilized by autoclaving, gamma irradiation and ethylene oxide in rats, Acta Cir Bras, 28, 66 (2013).
  32. Y Kawasaki, S Sotome, T Yoshii, et al., Effects of gamma-ray irradiation on mechanical properties, osteoconductivity, and absorption of porous hydroxyapatite/collagen, J Biomed Mater Res B Appl Biometer, 92, 161 (2010).
  33. Sodergard AaS, M. Properties of lactic acid based polymers and their correlation with composition. Prog Poly Sci, 6, 1123, (2002).
  34. BC Liu, R Harrell, RH Davis, MH Dresden, M Spira, The effect of gamma irradiation on injectable human amnion collagen. J Biomed Mater Res, 23, 833 (1989). https://doi.org/10.1002/jbm.820230803
  35. C Wiegand, M Abel, P Ruth, et al., Effect of the sterilization method on the performance of collagen type I on chronic wound parameters in vitro, J Biomed Mater Res B Appl Biomater, 90, 710 (2009).
  36. RZ Thomas, JL Ruben, JJ Bosch, MC Huysmans, Effect of ethylene oxide sterilization on enamel and dentin demineralization in vitro, J Dent, 35, 547 (2007). https://doi.org/10.1016/j.jdent.2007.03.002
  37. AY Ozer, NS Turker, S Colak, M Korkmaz, E Kilic, M Ozalp, The effects of gamma irradiation on diclofenac sodium, liposome and niosome ingredients for rheumatoid arthritis, Interv Med Appl Sci, 5, 122 (2013).
  38. H Nguyen, DA Morgan, MR Forwood, Validation of 11 kGy as a radiation sterilization dose for frozen bone allografts, J arthroplasty, 26, 303 (2011). https://doi.org/10.1016/j.arth.2010.03.032
  39. NS Turker, AY Ozer, E Kilic, M Ozalp, S Colak, M Korkmaz, Gamma-irradiated liposome/noisome and lipogelosome/ niogelosome formulations for the treatment of rheumatoid arthritis, Interv Med Appl Sci, 5, 60 (2013). https://doi.org/10.1556/IMAS.5.2013.2.2
  40. W Friess, M Schlapp, Sterilization of gentamicin containing collagen/PLGA microparticle composites. Eur J Pharm Biopharm, 63, 176 (2006). https://doi.org/10.1016/j.ejpb.2005.11.007
  41. R Franca, DA Mbeh, TD Samani, et al., The effect of ethylene oxide sterilization on the surface chemistry and in vitro cytotoxicity of several kinds of chitosan. J Biomed Mater Res B Appl Biomater, 101, 1444 (2013). https://doi.org/10.1002/jbm.b.32964
  42. AD Lucas, ME Stratmeyer, Extraction and stability of ethylene oxide residue in medical devices. Biomed Instrum Technol, 42, 76 (2008). https://doi.org/10.2345/0899-8205(2008)42[76:EASOEO]2.0.CO;2
  43. CE Holy, C Cheng, JE Davies, MS Shoichet, Optimizing the sterilization of PLGA scaffolds for use in tissue engineering, Biomaterials, 22, 25 (2001).
  44. NC, Effect of Terminal Gamma Sterilization on Osteoinductivity, RTI Biologics Inc. Alachua, FL. 2010.
  45. T Pekkarinen, O Hietalal, T Jamsa, P Jalovaara, Gamma irradiation and ethylene oxide in the sterilization of native reindeer bone morphogenetic protein extract. Scandinavian journal of surgery, 94, 67 (2005).
  46. RKA Singh, D Singh, A Malviya, Use of gamma-irradiated amniotic membrane for the healing of split skin graft donor site, Tissue Eng Regen Med, 10, 110 (2013). https://doi.org/10.1007/s13770-013-0004-5
  47. SH Park, S-H Park, DS Park YG Kang, JW Shin, HY Kim, TR Yoon, JW Shin, Characterization of a hybrid bone substitute composed of polylactic acid tetrapod chips and hydroxyapatite powder, Tissue Eng Regen Med, 10, 71 (2013). https://doi.org/10.1007/s13770-013-0357-9

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