Protocol when bone is very dense after grafting?

Any science behind this? Thanks

With all due respect, your comments are outrageous. There is no "problem coming". Allografts and xenografts have been used successfully for years, in implant dentistry, and other medical professions. There are also hundreds of studies by very well respected clinicians supporting their efficacy. With that said, I agree with the comment above, that if you use xenograft, you must mix it with autogenous bone or allograft, for various reasons. In fact, I think that creating composite grafts is the best way to go, whichever graft you choose. And that is where synthetics really shine: in a composite graft. For example, something like calcium sulfate mixed with allograft . Of course, in some countries allograft is not allowed, so in those places composite synthetic grafts maybe the best solution, depending on the case. Of course, the success of any graft is very case specific, and the outcome is very much influenced by many other factors, and not just the type of graft material chosen.

Forgot to mention that your comment about the FDA is totally erroneous, and reflects a misunderstanding of how these types of grafts and medical devices are even regulated. No government agency, including The FDA , would ever tell a surgeon how they should perform an accepted surgical procedure. In fact, you could perform surgery standing on your head if it worked for you , with no regulatory issues to fear. Of course you expose yourself to malpractice suits if you veer too far from standard practice and something goes wrong. What's considered standard of care in implant dentistry with regards to grafting is way outside the scope of this comment and probably moot. I'm not a lawyer. But I don't think any clinician would face any regulatory scrutiny whatsoever simply because they grafted with allograft or xenograft, and to suggest that is completely bonkers.

Doc Phil All medial devices have specific "indications for use" in their labeling. Please show me where any xenograft says that you can place an implant in the material. Thank you. Greg Steiner Steiner Biotechnology

As Dr. Miller says the problem is already here. Doesn't it seem reasonable that what holds the implant in could be a factor in its failure? Until recently dentists never considered that the type of bone the implant was placed in could be a factor in implant failure. I have been discussing the mechanism by which these grafts fail for a few years now and my purpose was only to get the profession to consider the bone when the implant fails. Greg Steiner Steiner Biotechnology

It's good thing you are not a lawyer. There are plenty of 510-K's for xenografts, and the indications for use in those 510-k's most assuredly cover procedures where dentists will place dental implants. Here is one, if anyone is interested: http://www.accessdata.fda.gov/cdrh_docs/pdf12/k122894.pdf Of course, the FDA doesn't spell out everything that you may put in a xenograft, it just says which procedures the xenograft is indicated for. The intention is that the products are cleared to be used in conjunction with other approved products used during the intended procedures. By your logic, it would be against FDA protocol to use any device with any type of other device, because neither is included in a detailed description of the other for the indication of use. Of course, this is completely absurd. The FDA is not writing surgical manuals. It's patently obvious that the procedures that are indicated for use with a xenograft may or can be used in conjunction with dental implants, because for many of the procedures mentioned as uses, there is no other reason for the intended use of xenografts as described in 510-k's, other for grafting in expectation of implants. What surgeon places xenografts in large osseous cavities just for fun? Anyway, this discussion is silly and it's clear based on your comments that you have an ulterior motive here. Hopefully, nobody will take what you say seriously, and your statements undermine the credibility of the products you are trying to sell. I won't be responding again, and I'll just leave it at the following fact: Xenografts have a long history of use and success in implant dentistry, as do allografts and synthetics. All these grafts can and will work when used correctly (alot has to do with case selection).

Just for giggles, I pulled up a 510-K for a synthetic graft material: Easy Graft. It is available here: https://www.accessdata.fda.gov/cdrh_docs/pdf13/K131385.pdf I guess, according to your warped logic, since dental implants are not mentioned in the indications of use, it would be against FDA protocol to use implants with this synthetic material? And amazingly, the 510-K for a synthetic graft, references Bio-Oss, the leading xenograft brand, as a predicate device? Anyway, this 510-K proves again that your arguments are completely silly. The 510-K's reference common procedures as indications for use, and obviously include other products that will be used in conjunction with the device under the 510-K during the procedure.

"if 100% Bio-Oss behaves more poorly than the equivalent allograft, alloplast, or even autogenous bone" Based on what peer-reviewed research is this statement being made? "Isn’t it amazing that Bio-Oss users now fully admit that xenografts should be mixed with other materials rather than in a defect with 100% xenograft?" Why is this amazing? I think the trend with all grafting materials, especially synthetics, is to form some sort of composite graft. So you are saying that whenever a composite graft is suggested the implication is that the components of the composite graft shouldn't be used at all? Surely, this doesn't make any sense. For example, Peter recommends a composite of b-TCP and CS, I believe. So does that mean that both b-TCP and CS shouldn't be used at all, because they are best used together?

"Then kindly explain why everyone is “trending” towards composite grafts? If xenograft behavior is so stellar, why are clinicians on the lecture circuit now recommending that Bio-Oss be mixed 50/50 with autogenous bone?" Hmm, because humans make progress and learn with time. Nothing wrong with changing opinions based on clinical results and trying to improve. Doesn't mean the original idea was hatched in some evil plot. I believe you have changed your protocols, and even your implant systems, with time also. Change and improvement is good. "Is there a conflict of interest here that you don’t want us to know?" No. Because as I have said many times, all of these bone grafts will work depending on how/where they are used. So I'm not in favor of any particular type of graft or composite, nor do I care what anyone here buys. I just found some of the comments from Greg about the FDA to be absolutely outrageous , so I chimed in. Personally, I like some of the alloplasts very much, and allografts are widely available in the US at good prices, so I tend to mix these. But, I certainly don't criticize someone for using another type of graft, especially when there is plenty of research to back up their use. Everyone should use what they feel most comfortable with and what they were trained on, whether its allograft, xenograft, or alloplast, and then try to stay up to date with new peer-reveiwed research, and education. Of course, implant dentistry is advancing daily, and what we believe in the past may not be the best way to do things in the future. But, I certainly wouldn't change my protocols that worked for years, because of some small sample size of anecdotal case histories where there could have been many other variables, other than the graft, that caused the failure.