Time-Release Calcium-Sulfate-Based Nanocomposite Gets FDA Approval
New York University’s College of Dentistry researcher, Dr. John Ricci, has received FDA approval for a new calcium-sulfate-based nanocomposite to stimulate bone regeneration. The nanocomposite, BoneGen-TR, resorbs more slowly and regenerates bone more consistently than currently available calcium sulfate treatments. This development will enable dentists to use the material in place of more expensive fillers in larger bone defects and in bone grafts for dental implant patients.
Although calcium sulfate has been used to stimulate bone growth for decades, its usefulness to dentists has been limited because it often resorbs before bone is fully regenerated. Many dentists, in fact, use the compound mainly to fill small voids, such as those found in post-extraction tooth sockets and periodontal bone defects, and only as an adjunct to other types of longer lasting bone graft materials.
Ricci, an associate professor of biomaterials and biomimetics, says that traditional calcium sulfate compounds are usually fully resorbed within six to seven weeks — often well before bone is fully regenerated. He and his colleagues, scientists from Orthogen Corporation, the research division of BioLok International, formulated the new nanocomposite to resorb more slowly by combining it with a small amount of a resorbable polymer. They experimented with several such combinations — each with a different polymer level — until settling on one that released calcium sulfate in just the right amount of time.
Ricci tested the new formulation in vivo by measuring how fast it dissolved and how much new bone it regenerated in the tibia — a hollow bone located between the knee and ankle. After 16 weeks, the compound had fully resorbed and had stimulated significant amounts of new bone. A multi-center clinical trial is planned that will include testing the new material’s performance on patients with post-extraction tooth sockets and periodontal bone defects.
The FDA approved Ricci’s new formulation in late March, and it will be on the market this fall. Biolok International is marketing the nanocomposite under the trade name BoneGen-TR.