Journal of Oral Science Research

Journal of Oral Science Research ›› 2022, Vol. 38 ›› Issue (3): 268-274.DOI: 10.13701/j.cnki.kqyxyj.2022.03.015

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In Vivo Safety Evaluation of Flexible Ceramic Materials

SUN Qian1, FENG Lifang1, LI Jingdong2, WANG Wuliang1, HAN Ziwen1, LIANG Ruiying1*   

  1. 1. North China University of Science and Technology, School of Stomatology, Tangshan 063000, China;
    2. Department of Oral and Maxillofacial Surgery, Tangshan Union Medical College Hospital, Tangshan 063000, China
  • Received:2021-11-04 Online:2022-03-28 Published:2022-03-25

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Abstract: Objective: To investigate the biosafety of flexible ceramic materials. Methods: The material extract or button samples were prepared. Skin irritation test, intradermal reaction test, delayed type hypersensitivity test, oral mucosal irritation test, and acute systemic toxicity test were conducted according to GB/T16886 biological evaluation series of medical devices. Results: The flexible ceramic material had no irritation, no intradermal reaction, no sensitization, no irritation of oral mucosa, and no short-term systemic toxicity. Conclusion: Flexible ceramic materials have excellent biosafety and meet the application requirements of oral surface contact materials.

Key words: flexible ceramic materials, biosafety, national standard