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

The purpose of a first-in-human study is to demonstrate an extrapolation of preclinical 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 the protocol amendments identified, the user handling experience learned, and the opportunity to modify the material to better perform in the human patient, as all represent important lessons learned. The notable increase in ISQ sheds light on the nature by which the glue was substituted for bone to yield a stable implant by the end of the study period.