Dental alloplastic bone substitutes currently available in Korea

被引:16
作者
Ku, Jeong-Kui [1 ,2 ]
Hong, Inseok [3 ,4 ]
Lee, Bu-Kyu [1 ]
Yung, Ph-Young [2 ]
Lee, Jeong Keun [5 ]
机构
[1] Asan Med Centr, Dept Oral & Maxillofacial Surg, Seoul, South Korea
[2] Armed Forces Capital Hosp, Sect Dent, Dept Oral & Maxillofacial Surg, Seongnam, South Korea
[3] Chonbuk Natl Univ, Sch Dent, Dept Oral & Maxillofacial Surg, Chonbuk Natl Univ Hosp, Jeonju, South Korea
[4] Chonbuk Natl Univ, Inst Oral Biosci, Res Inst Clin Med, Chonbuk Natl Univ Hosp,Biomed Res Inst, Jeonju, South Korea
[5] Ajou Univ, Inst Oral Hlth Sci, Dept Oral & Maxillofacial Surg, Sch Med, 164 WorldCup Ro, Suwon 16499, South Korea
关键词
Bone substitutes; Dental implantation; Korea; BIPHASIC CALCIUM-PHOSPHATE; BETA-TRICALCIUM PHOSPHATE; MESENCHYMAL STEM-CELLS; IN-VITRO; OSTEOGENIC DIFFERENTIATION; COLLAGEN MEMBRANE; CLINICAL-EVALUATION; RIDGE AUGMENTATION; SINUS AUGMENTATION; STROMAL CELLS;
D O I
10.5125/jkaoms.2019.45.2.51
中图分类号
R78 [口腔科学];
学科分类号
1003 ;
摘要
As dental implant surgery and bone grafts were widely operated in Korean dentist, many bone substitutes are commercially available, currently. For commercially used in Korea, all bone substitutes are firstly evaluated by the Ministry of Health and Welfare (MOHW) for safety and efficacy of the product. After being priced, classified, and registration by the Health Insurance Review and Assessment Service (HIRA), the post-application management is obligatory for the manufacturer (or representative importer) to receive a certificate of Good Manufacturing Practice by Ministry of Food and Drug Safety. Currently, bone substitutes are broadly classified into C group (bone union and fracture fixation), T group (human tissue), L group (general and dental material) and non-insurance material group in MOHW notification No. 2018-248. Among them, bone substitutes classified as dental materials (L7) are divided as xenograft and alloplastic bone graft. The purpose of this paper is to analyze alloplastic bone substitutes of 37 products in MOHW notification No. 2018-248 and to evaluate the reference level based on the ISI Web of Knowledge, PubMed, EMBASE (1980-2019), Cochrane Database, and Google Scholar using the criteria of registered or trademarked product name.
引用
收藏
页码:51 / 67
页数:17
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