Biomatériaux et applications médicales

Clinical Performance of Moldable Bioceramics and Resorbable Membrane for Bone and Mucosa Regeneration in Maxillofacial Surgery

Daculsi Guy, Seris Elodie, Christian Verner and Said Kimakhe

The objectives are to present the novel concept of moldable injectable osteogenic CaP bioceramic, and the data issued from a non-interventional study to demonstrate the efficacy of an injectable bone substitute (bioceramic/hydrogel) in association with a collagen resorbable membrane and the performance to guide bone regeneration and soft tissue healing in maxillofacial surgery. Historically, dental implantology required both bone augmentation and reconstruction. However, with the aging of the population, it is also necessary to prevent the bone loss after dental extraction. To overcome the limitations associated with autografts, several bone substitutes have been developed. However, there are still numerous difficulties in the handling, reproducibility of the resorption, and bone regeneration associated with the biomaterials. Therefore, it is important to optimize new bone substitute technologies. Bioactive injectable bioceramics, particularly putties, are often used in these applications. In this preclinical and clinical study, we demonstrate the efficacy and the performance of a combined use of calcium phosphate microporous granules and hydrosoluble polymers for maxillofacial bone reconstruction and regeneration. The biomaterial was extruded into bone defects and recovered by a
resorbable porcine collagen membrane, after tooth extractions in 78 patients. The clinical follow-up revealed no incidents or complications. Furthermore, infections or foreign body reactions were not reported during the 17 months of follow-up. We analyzed the drilling waste taken from 11 patients during the dental implantation sequence (at 5-10 months). Resorption and bone ingrowth were assessed using microtomography, scanning electron microscopy, light microscopy, and image analysis. We found that the highly kinetic process of resorption/absorption and bone in growth was achieved within a few months. The bone ingrowth was architectured and well vascularized.