Portal Rasmi Agensi Nuklear Malaysia

BONE GRAFT SUBSTITUTES AND PREPARATION METHOD THEREOF

Filing Number : UI20064505

 

BonïPorTM is a synthetic bone graft substitutes made from hydroxyapatite (main component of bone and teeth minerals). It is used to replace void/defect bone in a bone grafting procedure. It was design to be used by orthopaedic, craniofacial, maxillofacial and dental surgeons. BonïPorTM was designed and fabricated with an interconective porous structure mimics to real bone structure that can facilitate osseoconduction which promotes bone ingrowths thus offer faster healing and structure rigidity.

BonïPorTM is comprised of a single-phased hydroxyapatite scaffold with interconnected pore structure almost similar to human cancellous bone. It is synthetic, inorganic, biocompatible and osteoconductive. BonïPorTM is available in blocks of standard size 0.5 x 0.5 x 1 cm; and in irregular shaped chips of 2 – 3 mm. The device is designed as an osseoconductive space filler to be gently packed into bony voids or gaps following tooth extraction and other surgical procedures. The block is suitable for bigger defects while the chips are intended to completely fill the remaining gaps.

BonïPorTM has been evaluated for biosafety and of in vitro and in vivo study according to the FDA and ISO matrices including the ISO 10993 Standards for In Vitro and In Vivo Cytotoxicity & Biocompatibilty. The results showed that the products are non-toxic and biocompatible with living tissue.

The Clinical Trial – Phase I (Controlled Clinical Trials in healthy individual) for dental application was done to GCP protocols. The study was done on more than 60 patients involving insertion of BonïPoreTM into the alveolar bone after tooth extraction and regular follow-up. Clinically, no adverse reactions were seen both locally and systematically. Preservation of the alveolar ridge from resorption post tooth extraction was also observed.