To understand that we need a history lesson.
In the 1970s and 1980s, the promise of regenerating tissues became a possibility with the discovery of stem cells and molecules such as BMP-2. These discoveries prompted many scientists to invest their time and intelligence into developing materials and methods to regenerate lost tissues to great fanfare. The great fanfare about tissue regeneration led scientists to establish companies to market tissue regeneration products. However, because these were new products the regulatory requirements were burdensome and it was soon discovered that the costs required for FDA approval was overwhelming and virtually all of these companies folded as a result in the 1990s.
So what happened next?
The clinicians still wanted the ability to help their patients, so they turned to cadaver tissues. As transplant cadaver tissues did not require any FDA involvement, the materials went from the tissue banks to the clinicians and then to the patients without the scientific evaluation required for FDA evaluated products. The theories about how these tissue worked in patients were proven wrong, but the studies were ignored and the theories became dogma. Because the scientists are bypassed still today, no one knows what these tissues are doing in their patients. No one knows how mineralization is produced, what kind of bone is produced, or how long an implant will last when implants are placed in sockets grafted with these materials.
Allografts and xenografts never produce normal bone and this will ultimately be their downfall.
Autografts do not stimulate bone formation, but they are fully resorbed and they do produce normal bone.
The biggest use of allografts and xenografts is for grafting sockets. Obviously they must perform well for that purpose right? Wrong, because no one has studied the success rates for implants placed in sockets grafted with allografts or Bio-Oss. What I have just said is remarkable, but true. There are no legitimate studies on the success rates on implants placed in sockets grafted with allografts or Bio-Oss at any time frame. Yes, there is one dubious Puros study that no one but a Puros sales rep would consider science, but that is it. However, we do have good legitimate studies for implants placed in synthetics.
Implants placed in PerioGlas (Novabone) were found to have an 88% success rate over three years of loading. Socket Graft™ was found to have a 100% success rate after three years of loading. You have a scientific basis for placing implants in sockets grafted with synthetics, but you have no scientific basis for placing implants in sockets grafted with allografts or Bio-Oss.
A factor related to implant success and failure is marginal bone loss. We have two recent, very well done studies that have shown that cadaver bone grafts cause marginal bone loss. This is irrefutable. Sockets that have not been grafted and sockets grafted with resorbable bone grafts have never been shown to produce marginal bone loss.
