Research Project
9554914
ABSTRACT Dental implants are a central part of modern dental practice with the overall market for replacement and reconstruction of teeth expected to reach over $4 billion in the next several years. It is estimated that over 30 million people in the United States are missing all of the teeth in one or both of their jaws leading to lower quality of life. Most of these implants will be successful for long-term reconstruction, however, some fail early after implantations and some (up to 30%) eventually succumb to peri-implantitis which is usually caused by a bacterial biofilm infection. To counter peri-implantitis, current practice includes local and/or systemic antibiotic treatment and surgical removal of the infected bone area around the implant. Following surgical debridement of the infected bone, bone grafting with natural or substitute bone graft material is often performed. However, clinical experience has demonstrated that the current treatments including systemic and/or local antibiotic therapy, surgery, and combinations of these do not universally result in cure. BioVinc is a company founded to be a leader in bone related diseases and has recently demonstrated in the Phase I project, the feasibility of treating peri-implantitis with systemic delivery of a bisphosphonate-antibiotic (ciprofloxacin) conjugate. In this Phase II STTR proposal we will move the BioVinc peri-implantitis solution toward commercial use by combining the conjugate compound with a bone graft substitute material for use in this indication. The BioVinc solution will allow sustained local release of the antibiotic directly into the bone specifically at the area where surgical cleaning and graft placement was carried out, thus allowing high therapeutic concentrations of antibiotic to be achieved at the disease sites without the potential for systemic toxicities associated with these agents. Our plan is to seek approval of this combination as a class III device and thus have a streamlined regulatory pathway. Successful completion of the proposed work will allow us to commercialize our innovative conjugate/bone graft material, marking a significant advance in the treatment of peri-implantitis disease.
