First-in-Human Pilot Study to Assess Methodology for Using a Mineral-Organic Bone Adhesive for Optimization of Primary Stability & Implant Success for Implants Glued into Immediate Extraction Sockets and Immediately Temporized. Pilot Study 1.

The purpose of a first-in-human study is to demonstrate an extrapolation of pre-clinical data into the controlled human clinical arena. It is an opportunity to learn what does and does not translate well from experimental data. In that regard the current pilot study can be deemed a complete success. The implant survival rate of 71.4%, while disappointing, should be considered in light of protocol amendments identified, user handling experience learned, and the opportunity to modify the material to better perform in the human subject, as all represent important lessons learnt. The notable increase in ISQ sheds light on the nature by which the glue is substituted for bone to yield a stable implant at the end of the study period.