RevBio receives FDA approval to conduct US-based clinical trial for dental implant stabilisation

Clinical stage medical device company RevBio has received approval from the US Food and Drug Administration to start a 20-patient clinical trial to examine the safety and efficacy of its new biomaterial formulation.

The biomaterial is a more rapidly replaced and pH modified porous formulation of the company’s bone adhesive, Tetranite, used to stabilise dental implants following tooth extractions immediately.

According to the press release shared by the RevBio, the new formulation has shown evidence of a more biologically active bone substitution. While not osteoinductive, this version of Tetranite has shown characteristics which the company describes as being “osteopromotive”.

RevBio hopes that the new Tetranite biomaterial will help reduce the duration and complexity of dental implant procedures, lessen patient pain and recovery time and reduce the overall cost of care thereby providing greater patient access for the treatment of tooth loss.

“Frequently, extraction sites are too large for dental implants to achieve primary stability through conventional mechanical engagement. Instead, patients must undergo a costly, complex and lengthy process including a preliminary bone grafting surgery before receiving a dental implant… The use of Tetranite to stabilise an unstable implant will allow for the immediate placement of dental implants which otherwise could not be placed until the initial bone graft has healed to form new bone,” said the company.

The original Tetranite formulation (left) shows very little substitution with new bone and appears white, which indicates the presence of the biomaterial. The more “osteopromotive” formulation (right) shows significant bone in-growth with the red and pink areas indicating new bone substituting the biomaterial (Image: RevBio)

Dr Paul A Fugazzotto, a periodontist based in Massachusetts with over 30 years of experience placing dental implants, and Dr Kanyon Keeney, an oral and maxillofacial surgeon based in Virginia whose clinical practice focuses exclusively on dental implant surgery, will conduct the trial.

“This product is truly transformational,” said Dr Fugazzotto. “Tetranite will revolutionise how implant dentistry will be performed. The adhesive properties and handling characteristics of this material are incomparable to any product on the market.”

“We are truly excited to conduct this study with both Dr Fugazzotto, who will initiate this study enrolling the first cases, along with Dr Keeney,” said Alan Pollack, senior director of dental clinical operations at RevBio. “The improvements we have made to the technology have accelerated both the bone substitution profile and the product’s adhesive strength. We look forward to enrolling our first patients in the coming weeks.”