Human Bone RIgeneration in MAXillo-facial area using an innovative medical device for Tissue engineering (BRIMAX)

Abstract

Bone regeneration today is one of the most important challenges for medicine and the need for this is particularly evident in the maxillo-facial area: our clinical trial will be based on a model of bone defect as in alveolar socket preservation and sinus lift augmentation, well described surgical techniques. The RIGENERA® system permits extraction of stem cells from a small sample of connective tissue obtained from the patient’s lingual mucosa or from a post-extraction surgical site (where an endosseous implant may be inserted), dental pulp or dental follicle. Our project is to demonstrate the efficacy in the maxillo-facial area of an innovative clinical protocol of bone tissue engineering based on a new medical device called Rigeneracons (CE certified Class I). Our clinical trial use already acquired technologies in comparation with new technologies (new selection methods, new Bio-compatible materials etc.) produced by us. Besides, we perform an in-vitro test to quantify the proliferative capacity of a cellular suspension obtained after disaggregation of connective tissue originating from the oral cavity using the RIGENERA® system, a biologic tissue disaggregator (Human Brain Wave–Torino, Italy) that recently came on the market. Evaluation of the histologic characteristics of neo-formed osseous tissue will be shown and discussed.