RevBio has received approval from the US Food and Drug Administration (FDA) to initiate a pilot dental clinical trial evaluating the safety and efficacy of its regenerative bone adhesive, Tetranite.
The study will assess the use of Tetranite in dental ridge augmentation procedures, with the aim of enabling bone grafting without the need for ancillary containment devices such as membranes, meshes, tacks or screws. According to the company, the material is designed to adhere directly to surrounding bony walls at the graft site, providing stability during healing.
Rahul Jadia, PhD, RevBio’s research and development manager for technology development, said the adhesive properties of the product distinguish it from existing graft materials. He added that the scaffold is gradually replaced by bone within a clinically relevant timeframe, while maintaining volume, adhesive performance and mechanical strength, which may help streamline complex dental procedures.
Dental ridge augmentation is commonly required prior to implant placement, particularly among patients with bone loss. RevBio estimates that approximately 44% of dental implant patients present with missing teeth at the start of treatment, often accompanied by varying degrees of bone resorption. Current ridge augmentation techniques typically rely on particulate bone grafts secured with fixation and containment devices to protect the graft during healing. However, in more than 30% of cases, these materials do not achieve the intended clinical outcome, potentially necessitating additional grafting procedures and extending treatment time and cost.
The development of Tetranite has been supported by a series of research grants totalling $1.8m from the Translational Resource Centre (TRC), a research consortium funded by the National Institute of Dental and Craniofacial Research (NIDCR). Additional funding of $2m was provided through a Direct to Phase II Small Business Innovation Research (SBIR) grant from the NIDCR to support pre-clinical research and progression to clinical evaluation.
Commenting on the development, David H Kohn, PhD, director of TRC and professor at the University of Michigan, said the technology addresses a significant unmet clinical need in dentistry. He noted that the TRC has provided translational support to help guide the product towards regulatory approval and the commencement of first-in-human clinical trials.
All images courtesy of RevBio.
