Source abstract
Abstract
This study assessed the corrosion resistance, intracutaneous reactivity, acute systemic toxicity, and in situ tissue effect of the implantation of porous NiTi fabricated by metal injection molding in animal models. For the intracutaneous reactivity study, five intracutaneous injections were administered per site with and without the tested extract in polar and nonpolar solutions. The extract was also delivered via intravenous and intraperitoneal routes for acute systemic toxicity. TiAl6 V4 (control) and porous NiTi were implanted in rabbit femora for a period of 13 weeks to evaluate the in situ tissue response. Corrosion was evaluated through open and cyclic polarization in PBS, while biocompatibility was investigated by assessing the general conditions, skin irritation score (edema and erythema), and histopathology. No active dissolution or hysteresis loop was observed in the corrosion study. None of the animals exhibited death, moribundity, impending death, severe pain, self-mutilation, or overgrooming. No edema was observed at injection sites. Only the positive control showed an erythematous reaction at 24, 48, and 72 h observations ( p < 0.001). Porous NiTi showed a low in situ biological response for inflammation, neovascularization, and fibrosis in comparison to the control implant ( p = 0.247, 0.005, and 0.011, respectively). Porous NiTi also demonstrated high pitting corrosion resistance while causing no acute hypersensitivity or acute systemic toxicity. The study concludes that porous NiTi implants were unlikely to cause local sensitization, acute systemic toxicity, or chronic inflammatory reactions in an animal model. Porous NiTi also exhibited osseointegration equivalent to Ti6AI4 V of known biocompatibility.
Source: openalex_inverted_index · Quality: baseline
Affiliations
Centre for Restorative Dentistry Studies, Faculty of Dentistry, Universiti Teknologi MARA (UiTM), Sungai Buloh Campus, Jalan Hospital, Sungai Buloh 47000, Malaysia
Integrative Pharmacogenomics Institute (iPROMISE), Universiti Teknologi MARA, Puncak Alam Campus, Bandar Puncak Alam, Selangor 42300, Malaysia
Department of Applied Physics, Faculty of Science & Technology, National University of Malaysia, Bangi, Selangor 43600, Malaysia
Centre for Oral & Maxillofacial Surgery Studies, Faculty of Dentistry, Universiti Teknologi MARA (UiTM), Sungai Buloh Campus, Jalan Hospital, Sungai Buloh, Selangor 47000, Malaysia
Smart Manufacturing Research Institute (SMRI), College of Engineering, Universiti Teknologi MARA, Shah Alam, Selangor 40450, Malaysia
Centre for Restorative Dentistry Studies, Faculty of Dentistry, National University of Malaysia, Jalan Raja Muda Abdul Aziz, Kuala Lumpur 50300, Malaysia
Restorative Dental Sciences, Faculty of Dentistry, The University of Hong Kong, Prince Philip Dental Hospital, 34 Hospital Road, Sai Ying Pun, Hong Kong
Faculty of Pharmacy, Universiti Teknologi MARA, Puncak Alam Campus, Bandar, Puncak Alam, Selangor 42300, Malaysia
Funding
Kementerian Sains, Teknologi dan Inovasi
References (40)
Show source-provided references
11. Rhalmi S. · Biomed Mater. Eng. · 1999 · 9 · 151
15. International Standard ISO 10993, 3 Edition: 2016-12–01, Biological Evaluation of Medical Devices - Part 6: Test for Local Effects after Implantation; International Organization for Standardization, 2007.
16. Kumar V · 2017
20. Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices (Superseded), ASTM F2129–15 ASTM International, (West Conshohocken, PA, approved 2015).
21. International Standard ISO 10993, Biological Evaluation of Medical Devices - Part 10: Test for Irritation and Skin Sensitization. ISO 10993–10:2010(E); 3 Edition, International Organization for Standardization, 2010.
22. International Standard ISO 10993 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity. ISO 10993–11:2006(E); 2 Edition, International Organization for Standardization, 2017.
23. International Standard ISO 10993, Biological Evaluation of Medical Devices - Part 6: Tests for local effects after implantation; 3 Edition, International Organization for Standardization, 2007.
24. International Standard ISO 10993, Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials; 4 Edition, International Organization for Standardization, 2002.
25. International Standard ISO 10993, Biological Evaluation of Medical Devices - Part 2: Animal Welfare Requirements; 2 Edition, International Organization for Standardization, 2006.
26. Turner P. V. · J. Am. Assoc Lab Sci. · 2011 · 50 · 600
27. Nitium Technology Sdn. Bhd. Advanced Medical and Dental Institute (USM), NiTiDent Tuah: Test for local effect after implantation in femur of Oryctalagus cuniculus using International Standard Method ISO 10993-Part 6. GLP 18/03. 202228.
28. Chen P. H. · J. Am. Assoc Lab Anim Sci. · 2006 · 45 · 57
30. Cempel M. · Pol J. Environ. Stud. · 2006 · 15 · 375
31. OECD 2000 Guidance Document on the Recognition, Assessment, and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation; Organization for Economic Cooperation and Development 2000.