The U.S. Food and Drug Administration (FDA) recently finalized a guidance document for manufacturers of dental bone graft materials and devices, with the core goal of reducing reliance on animals in research.
The guidance provides manufacturers with recommendations for complying with relevant special control requirements and emphasizes increased transparency in animal research.
The FDA noted: “The document proposes measures to help reduce the number of animals used and supports the ‘3Rs’ of replacing, reducing, and improving animal use.” Furthermore, the guidance encourages manufacturers to proactively communicate with the FDA if they plan to adopt non-animal research methods.
With advances in regenerative medicine and novel biomaterials, as well as the increasing demand for bone repair, the use of bone grafts in dental implant surgery is becoming increasingly common. A 2021 study showed that approximately 50% of dental implant procedures require bone grafts.
Approximately 2.2 million such procedures are performed annually worldwide, with the relevant market value estimated at $664 million in 2021, and the number of procedures is expected to grow at an annual rate of 13%.
Currently, autologous transplants (using the patient’s own bone) remain the gold standard for restorative procedures in the oral, craniofacial, and other areas.
However, animal-derived bone materials (xenografts) are widely used in dental bone transplantation. Research indicates that cattle and pig bones are the most common sources, with bones from horses, camels, and ostriches also used in isolated cases.
Bone transplantation dates back centuries. As early as 1668, Dutch surgeon Job van Meekeren successfully transplanted a canine skull onto the head of a Russian soldier, achieving complete fusion. This is considered the first successful bone transplant.