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치과재료의 피부 감작성 평가를 위한 용출 시험 및 용출물 분석

Extraction Test and Extracts Analysis of Dental Materials Products for Skin Sensitization Test

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초록

Skin sensitization is important test of biological evaluation in dental materials, where it is one of the frequently carried out test along with cytotoxicity and irritation test. The preparations of test materials and both positive and negative control materials are very important factor during the process of the test, while the extraction process of these materials are also need to be considered as most of the dental materials are extracted for the use as the test materials in skin sensitization test. This research focused on preparation of positive and negative materials, and also the actual dental materials made from metal or ceramics. Prepared materials were then extracted in appropriate solvent, extract temperature and durations. Finally, extracted liquids were analyzed for appearance, pH and chemical components in the extracted chemical. It is expected that provision of such extract method for dental materials along with preparation method of positive and negative control materials and analyses of them, would be helpful to both manufacturer and reviewer. They will provide improvements for medical device safety control, which would then linked to improvements of competencies in evaluators as well as providing safety for public health as the of primary consumer, medical 1) would enhance safety system professionals, as well as final consumer of public.

Abstract

Skin sensitization is important test of biological evaluation in dental materials, where it is one of the frequently carried out test along with cytotoxicity and irritation test. The preparations of test materials and both positive and negative control materials are very important factor during the process of the test, while the extraction process of these materials are also need to be considered as most of the dental materials are extracted for the use as the test materials in skin sensitization test. This research focused on preparation of positive and negative materials, and also the actual dental materials made from metal or ceramics. Prepared materials were then extracted in appropriate solvent, extract temperature and durations. Finally, extracted liquids were analyzed for appearance, pH and chemical components in the extracted chemical. It is expected that provision of such extract method for dental materials along with preparation method of positive and negative control materials and analyses of them, would be helpful to both manufacturer and reviewer. They will provide improvements for medical device safety control, which would then linked to improvements of competencies in evaluators as well as providing safety for public health as the of primary consumer, medical 1) would enhance safety system professionals, as well as final consumer of public.

참고문헌 (26)

  1. "식품의약품안전처 고시 제2020-12호. 의료기기의 생물학적 안전에 관한 공통기준규격", ~ (2020)
  2. "식품의약품안전처 고시 제2021-83호. 의료기기 품목 및 품목별 등급에 관한 규정", ~ (2021)
  3. Browne RM., "Animal tests for biocompatibility of dental materials--relevance, advantages and limitations", J Dent, 22, pp.S21~24 (1994)
  4. Camps J, "Influence of the powder", liquid ratio on the properties of zinc oxide-eugenol-based root canal sealers, 2004, pp.20, 915~923
  5. Coleman KP, "Preparation of irritant polymer samples for an in vitro round robin study", Toxicol In Vitro, 50, pp.401~406 (2018)
  6. De Boeck M, "In vitro genotoxic effects of different combinations of cobalt and metallic carbide particles", Mutagenesis, 18, pp.177~186 (2003)
  7. De Jong WH, "Round robin study to evaluate the reconstructed human epidermis(rhe)model as an in vitro skin irritation test for detection of irritant activity in medical device extracts", Toxicol In Vitro, 50, pp.439~449 (2018)
  8. Geetha C, "Pre-clinical evaluation of titanium nitride coated titanium material", Toxicol Mech Methods, 22, pp.144~150 (2012)
  9. Gerberick GF, "Compilation of historical local lymph node data for evaluation of skin sensitization alternative methods", Dermatitis, 16, pp.157~202 (2005)
  10. International Organization for Standardization, "ISO 10993-1:2018, Biological evaluation of medical devices –Evaluation and testing within a risk management process", ISO, ~ (2018)
  11. International Organization for Standardization, "ISO 10993-10:2010, Biological evaluation of medical devices – Evaluation and testing within a risk management process", ISO, ~ (2010)
  12. International Organization for Standardization, "ISO 10993-12:2021, Biological evaluation of medical devices – Sample preparation and reference materials", ISO, ~ (2021)
  13. International Organization for Standardization, "ISO 10993-17:2002, Biological evaluation of medical devices – Establishment of allowable limits for leachable substances", ISO, ~ (2002)
  14. Kwon JS, "Cytotoxicity evaluation of zinc oxide-eugenol and non-eugenol cements using different fibroblast cell lines", Acta Odontol Scand, 72, pp.64~70 (2014)
  15. Maccauro G, "Alumina and zirconia ceramic for orthopaedic and dental devices", Biomaterials applications for Nanomedicine, 3, pp.485~ (2011)
  16. Murphy JV, "Intoxication following ingestion of elemental zinc", JAMA, 212, pp.2119~2120 (1970)
  17. Paim TC, "Evaluation of in vitro and in vivo biocompatibility of iron produced by powder metallurgy", Materials Sci Eng C Mater Biol Appl, 115, pp.111129~ (2020)
  18. Petersen EJ, "Characteristics to consider when selecting a positive control material for an in vitro assay", Altex, 38, pp.365~376 (2021)
  19. Piao MJ, "Silver nanoparticles induce oxidative cell damage in human liver cells through inhibition of reduced glutathione and induction of mitochondria-involved apoptosis", Toxicol Lett, 201, pp.92~100 (2011)
  20. Reeve L, "Biocompatibility assessments for medical devices-evolving regulatory considerations", Expert Rev Med Devices, 14, pp.161~167 (2017)
  21. Sarrami N, "Adverse reactions associated with the use of eugenol in dentistry", Br Dent J, 193, pp.257~259 (2002)
  22. Setcos JC, "The safety of nickel containing dental alloys", Dent Mater, 22, pp.1163~1168 (2006)
  23. Sidambe AT, "Biocompatibility of advanced manufactured titanium implants—a review", Materials, 7, pp.8168~8188 (2014)
  24. Syed M, "Allergic reactions to dental materials-a systematic review", J Clin Diagn Res, 9, pp.Ze04~09 (2015)
  25. Vinardell MP, "Alternative methods for eye and skin irritation tests : An overview", J Pharm Sci, 97, pp.46~59 (2008)
  26. Wiltshire WA, "Allergies to dental materials", Quintessence Int, 27, pp.513~520 (1996)

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