Comparison of two bone substitute biomaterials consisting of a mixture of fibrin sealant (Tisseel®) and MBCP™(TricOs®) with an autograft in sinus lift surgery in sheep

Abstract

The aim of this study was to assess the efficacy and safety of macroporous biphasic calcium phosphate (MBCP())/fibrin grafts (TricOs((R)))/(Tisseel((R))) for sinus lift augmentation in sheep. Autologous bone grafts were used as a positive control, and dental implants were placed to assess the efficiency of the composite. A total of 12 adult sheep (24 maxillary sinuses) were randomized to receive sinus lift augmentation with MBCP()/fibrin grafts obtained by either simultaneous or sequential addition of thrombin and fibrinogen to MBCP(), or autologous bone grafts. Six months post-sinus lift surgery, dental implants were placed. At 6 months post-sinus lift and 3 months after dental implant placement, the characteristics of newly formed bone and dental implant stability were assessed. The methods used were radiography, scanning electron microscopy, light microscopy, micro-CT analysis, radio frequency analysis (RFA), and image analysis. There were no clinical adverse events in the post-operative period. New bone formation was similar for MBCP()/fibrin grafts and autografts at 21-20% and 20%, respectively, at 6 months, and at 34-35% and 35%, respectively, at 9 months. Implantability of dental implants was better at the time of placement with MBCP()/fibrin grafts than autografts at 81-88% and 69%, respectively. Three months after placement, RFA showed better implantability with MBCP()/fibrin grafts than with autografts at 75-82% and 71%, respectively. The bone contact measurements were around 50% for the three groups, without significant differences. This study shows that following sinus lift augmentation in sheep, MBCP()/fibrin grafts support new bone formation that is comparable to autografts, while providing better support for the dental implants.