|
KMID : 1142220170120010083
|
|
Regulatory Research on Food, Drug & Cosmetic
2017 Volume.12 No. 1 p.83 ~ p.91
|
|
|
A Study on Development of the Fatigue Limit of Temporary Dental Implants
|
|
Kim Mee-Hye
Cho Eun-Jeong
Lee Ji-Won
Kim Eun-Kyo
Park Chang-Won
|
|
|
Abstract
|
|
|
A temporary dental implant, a medical device temporarily used to support a prosthesis such as an artificial tooth used for restoring patient's masticatory function during implant treatment, is implanted in the oral cavity to substitute for a tooth. As dental diseases increase due to an aging population and westernization, tooth extraction and implantation increase, resulting in an increase in the development and utilization of temporary dental implant products. However, implant fracture occurs even during temporary utilization because of the fatigue caused by the continuous dynamic load imposed on the implant by mastication. Hence, measuring the fatigue of a temporary dental implant is an important method of evaluating the performance. The ISO 14801 standards present only a method of testing fatigue for dental implant, but there is no separate test standard about the fatigue of implant fixture in the domestic and international standards and guidelines. For this reason, individual manufactures provide their own test standards or applied to the products a fatigue limit of 250 N or higher according to the Dental Implant Safety and Performance Test Reference Manual. This study is intended to 1) review the appropriateness of the test method of the fatigue of temporary dental implants, and to 2) verify the test standard for temporary dental implants for the cases where the fatigue test method for permanent dental implants is applied according
to the ISO 14801 standards. The results showed that the fatigue limit may be provided proper standards in individual manufacturer, rather than applying the fatigue limit of 250 N or higher. Or, in order to set the fatigue to 250 N, the manufacturer should suggest a test method other than that used in this study. The results of this study may be useful for the establishment of the fatigue standards and fatigue test methods of the manufacturers and importers of temporary dental implants.
|
|
|
KEYWORD
|
|
|
Temporary dental implant, Safety, Performance, Fatigue, Guideline
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|
|