Developing the nation’s first bioactivity material application implant prototype

Megagen Implant Co., Ltd.(Gwang-bum Park, CEO)

Dental implants cope with tooth https://korean-products.com/inquirydefects and are the most representative method so far. The core subject in developing dental implants is minimizing patient’s inconvenience by reducing implant treatment periods. To so this, implant specialized companies are working on researches for various surface treatment methods. Nevertheless, the researches still have not yet reached a satisfactory level. On this occasion, Megagen succeeded in developing an implant system that has much more outstanding effects than existing implants through osteogenesis promoting protein coating technique development to reduce the osseous integration period. Currently, safety and validity evaluation are in progress to commercialize this development, and a clinical test request has been submitted to the Ministry of Food and Drug Safety. It is expected that this new conceptual implant system development that has never been initiated before in other domestic or foreign companies will create a new market and resolve patient inconvenience
through faster osseous integration.

Implant fastener design and prototype development to load bioactivity materials

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The core contents developed by Megagen Implant Co., Ltd.
through the research task of “bio-fusion next generation dental implant technical development” can be broadly summarized as implant fastener design and prototype development to load bioactivity materials, bioactivity materials quantification, and bioactivity materials loading process development. First, regarding implant fastener design and prototype development to load bioactivity materials, implant structure needs to be designed similar to natural tooth, to raise the level of closeness with remained bone, and to minimize practitioner’s technique sensitivity so that the practitioner can feel convenience. While processing implant design in this way to optimize bioactivity material application, an implant fastener with broad surface area was designed with key concept of raising initial fastening power, an important factor to achieve a high implant success rate,
securing differentiation from existing implants. Also, design stability was assessed through finite-element interpretation to verify dynamic stability concerned by differentiated appearance from existing implants, and dynamic weak points were resolved
through design improvement in implant connection area that often causes structural vulnerability. Moreover, various methods including holes and grooves were reviewed to secure a space for loading bioactivity material on implant surface, and industrialization was progressed for final product with a model (Deep & Knife Thread) having increased surface area, as it is based on a review process for mass-production that sufficient effects can be expected with increased surface area only. The development proceeded to have synergy effects with bioactivity materials coating by applying calcium ion coating method, a surface treatment developed by Megagen, additionally to the bioactivity materials coating.

Bioactivity material quantification and bioactivity materials loading process development

Untitled-5.jpgSubsequently, regarding bioactivity material quantification, quantification for coated amount on individual implant proceeded to implement optimized bioactivity material performance and optimize osseous integration. Bioactivity materials can promote osteogenesis depending on the amount, and may also have negative effect on the other hand. Therefore, selecting optimized amount is required to promote osteogenesis. Also, the evaluation was conducted using various animals to select bioactivity material amount, and finally product assessment was conducting using a mini pig (60kg) that has similar weight with a human being. In results of animal testing, amount suitable for implant was selected, and the process was developed using that amount.

Finally, regarding the bioactivity material loading process, constructing the coating facility was carried out to develop the mass production of bioactivity material loading implant. Dental implant is a medical device for which sterilization is essential. Currently being used implant sterilization methods are sterilization with gamma-ray irradiation. Whereas a bioactivity material is a protein capable of being destroyed by gamma-ray, it is clear that gamma-ray cannot be used for product sterilization. The product was developed and the prototype was produced through a bacteria-free process that does not require sterilization process. Moreover, ultrasound bath was produced to process bioactivity materials coating for the automation of the implant surface coating process, for which components including coating jig and ample were designed and manufactured. In addition,
production processes that optimize time required for coating and time required for each stage were established.

Bioactivity material optimized performance implementation and osseous integration optimization

Likewise, the implant product that won the industrial technical award of the month has distinction compared to existing implants.
Initial implant fastening power with broadened surface area is a key factor that governs implant success rate. A screw thread with broad surface area is required for high initial fastening power, and such high initial fastening power and dispersing the load were achieved by applying deep screw thread that was not tried before in existing implants. Also, convenience in the operation was enhanced compared to existing implant by simplifying the operation process through the application of identical core diameter to various diameters. Moreover, the coating process of BMP-2, a osteogenesis promoting protein, was developed and the prototype was produced to reduce osteogenesis period. Because industrialization of osteogenesis promoting protein is impossible in normal processes, new processes differ from existing implant producing processes were developed for the industrialization. In addition, because the existing implant sterilization method that uses gamma-ray cannot be used due to the characteristics of protein, the final prototype was developed by applying a bacteria-free facility to solve this issue.
A clinical evaluation request for full industrialization of bioactivity materials coating implant is currently being processed. Gwang-bum Park, the CEO of Megagen who is planning for full industrialization through subsequent clinical evaluation said, “When the industrialization is completed through clinical evaluation, the first dental implant where osteogenesis promoting protein is applied shall be released in the market.” and “This secured technology would be utilized in releasing various product groups including bone graft materials where osteogenesis promoting protein is applied.”

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