RevBio has gained U.S. Food and Drug Administration (FDA) approval to begin a pilot clinical trial to assess its TETRANITE regenerative bone adhesive to perform dental ridge augmentation procedures without needing ancillary containment devices like membranes or meshes, or fixation aids like tacks and screws.

According to the company, about 445 of patients needing a dental implant have a missing tooth when they begin treatment with varying degrees of bone loss, depending on how long the tooth has been missing. These patients must undergo a ridge augmentation procedure in which particulate-based bone graft materials are placed using additional fixation and containment devices to protect the graft during the healing process.

These procedures increase the width and height of a jawbone to reconstruct atrophied bone so a dental implant can be successfully placed. In over 30% of these cases, however, existing bone graft materials fail to achieve the desired clinical results, and further bone grafting procedures must be conducted, increasing treatment time and cost.

This product development program was funded since its inception by grants totaling $1.8 million from the  Translational Resource Center (TRC), a research consortium funded by the National Institute of Dental and Cranial Research (NIDCR) to improve translation of promising tissue engineering and regenerative medicine technologies. RevBio’s funding for this program was further enhanced by a $2 million Direct to Phase II Small Business Innovation Research (SBIR) grant from NIDCR to complete the preclinical research necessary to advance this product into its current clinical state of development.

“The ability for the product to adhere to the surrounding bony walls of a site that needs to be grafted is a fundamentally unique attribute of TETRANITE,” said Rahul Jadia, Ph.D., RevBio’s R&D manager of technology development, who has led the development of this novel adhesive bone scaffold product. “Equally impressive is the fact that the material is substituted with bone in a clinically relevant timescale without significant loss of volume or adhesive and mechanical strength, which will ultimately help accelerate the course of complex dental procedures.”

In November, the company received FDA approval for a 20-patient study to measure TETRANITE’s safety and efficacy to treat complex, multi-fragmented wrist fractures, including those that involve articular surfaces.