Clinical Studies

Extensive human and animal studies have shown the osseoconductive properties of SynthoGraft:

• Rapid bone regeneration in critical size defects at early implantation times has been observed.
• Micro-computed tomographic analysis of retrieved human cores at 3, 6, and 12 months following sinus lift procedures have shown bone-to-grafting material volume ratios ranging from 78 to 98% as early as 3 months.
• No foreign body responses were detected.

A transmission electron micrograph (TEM) showing the structurally interconnected nanometer size porosity of SynthoGraft.	Histologic 3D core reconstruction analysis showed significant new bone formation in sinus grafted regions.
3 month histology.	6 month histology.
Retrieval of sinus elevations after 3 and 6 months showed progressive resorbtion of SynthoGraft particles and increasing bone regeneration.

Laboratory Studies

Extensive laboratory studies have demonstrated the unique physical properties of SynthoGraft:

• Nanometer-scale porosity
• Pure, synthetic material
• Cellular-level biocompatibility

Micrometer and nanometer pore size for optimized material dissolution and bone regeneration rates.	In vitro cytotoxycity assays confirmed the cellular-level biocompatibility of SynthoGraft.
A series of physico/chemical analysis showed that SynthoGraft is 99% pure β-TCP.	6–9 month histological analysis revealed increased osteoclast activity.