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.

OBJECTIVES

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.

MATERIALS AND METHODS

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.

RESULTS

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.

CONCLUSIONS

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.