Protocol when bone is very dense after grafting?

A 60+ year old healthy male had a sinus lift and bone graft in the upper maxillary area to create a ridge for implants. 6 months after healing, I laid a flap to see if the bone was dense. The bone actually appeared very dense and there was hardly any bleeding when I drilled the osteotomy sites. I tried to create some bleeding along the osteotomy walls. I placed two implants uneventfully. I am wondering now if with such dense bone and such little bleeding will these implants osseointegrate? Will there be enough clotting factors to allow the implant to integrate and heal? What is the protocol is when the bone is so dense after grafting?

19 Comments on Protocol when bone is very dense after grafting?

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Jawdoc
5/7/2016
Dip implant in PRP. Insert a little PRF into the osteotomy. Torque in the PRP-soaked implant into the osteotomy which now contains PRF. Together with the bleeding that u have induced, it should be fine.
Peter Fairbairn
5/7/2016
Mainly as it is not "bone" but a hard material we need to think a bit a quality of regenerated tissue ...not just quantity . Did you take a core sample? and which material was used ?
sb oms
5/8/2016
I see this with xeongraft sinus lifts occasionally. The bone is very dense and you must follow the correct drilling protocol. The bone is cortical in nature with very few blood vessels. That being said, I have not found a correlation to this finding and early or late implant failure, which is really the important thing. When I use xenograft (bio-oss), I use a mix of mixture of large and small particle. This should, theoretically, allow for more ingrowth of blood vessels. I'm sure I will get a few people throwing rocks at me for talking about bio-oss, but the proof is in the implant survival.
TraumaDoc
5/10/2016
My first reaction was what is actually up there? The above comments are good to consider. Given the implants are submerged and have primary stability I would allow at least 6 months healing time. Torque test before restoring. Also vitamin D deficiency is epidemic in this ake group. I put my patients on 10,000 IU/day and Vitamin K2 300mcg/day. K2 is an important cofactor for D. You can have her tested first. While 40mcg/dl is considered passing, 80 is what I shoot for. Up to 100 is considered normal. This is my protocol for all implant patients for last 3 years. I have had 99% success rate in the real world with 50% being immediate placements after extraction...
Kastytis Zymantas
5/11/2016
Any science behind this? Thanks
Robert J. Miller
5/10/2016
I get a lot of revision cases in my practice, especially those related to failed bone grafts. The one common thread in these failures is the use of xenografts, especially when they are not mixed with a resorbable material. I am amazed at the profligate use of this material, particularly in sites with high loading values. Failure to resorb, fibrous encapsulation, foreign body reactions, low modulous of elasticity, late implant failures, and low to non-existent vascularity are parameters that we have been dealing with ever since this material was introduced. Why anyone would use this in atrophic posterior maxilla is a mystery to me, considering that bone density under normal conditions is the poorest of any intraoral site. Low vascularity in your graft is now something you will have to contend with. Hopefully you have placed implants with sufficient surface area to compensate for this low percentage of bone-to-implant contact. Next time you do this type of case, use a graft that will give you a better clinical outcome. RJM
David Levitt
5/10/2016
Amen Dr. Miller. I have taught bone grafting courses for the Perio Institute for many years and I constantly tell my students that some autogenous bone must be mixed with any type of xenograft. If it is unavailable use human bone (allograft). The easiest way to obtain autogenous bone is to use a bone scraper on the lateral wall of the sinus and harvest filings until you see a color change in the wall indicating you are near the membrane.
Peter Fairbairn
5/11/2016
Yes Drs Millar and Levitt , that is biology . If you want a great x-ray picture for your lecture throw a lot of HA ( Xenograft ) in and it will look "Ideal " . But there will be up to 40% less host bone ( HL Chan and HL WAng , JOMI systemic review ) , so you may get only 15-25 % host bone in 6-8 months and the rest is doing nothing but making your glorious looking Picture ... We now have materials that are highly osteo-inductive helping the host to regenerated over 50% new host bone in as little as 8-10 weeks ...... Yes Sboms my Nokia was great it worked and was reliable but now I prefer my iPhone , does the same just a lot more as well . Regards Peter
greg steiner
5/12/2016
Amen again to Dr. Miller, Peter and the rest. When you looked into the osteotomy you were looking at dense mineralization but not normal bone. The term to describe this tissue is sclerotic bone. You were right to be concerned about vitality because there is very little vital tissue present. I do not believe integration ever occurs in this tissue and believe it functions like a screw in wood until like Dr. Miller has noted the sclerotic bone breaks down and failure occurs. There is no scientific proof that integration ever occurs with allografts or xenografts. For the reasons cited the FDA does not permit implants to be placed in these graft materials. As Dr. Miller has noted we have a huge problem coming with implants placed in these materials that do not resorb and do not produce normal bone. If you are interested in the histology and process of bone failure of these materials you can check out the publications page of our web site. Greg Steiner Steiner Biotechnology
Doc Phil
5/12/2016
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.
Doc Phil
5/12/2016
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.
greg steiner
5/16/2016
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
greg steiner
5/16/2016
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
doc phil
5/16/2016
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).
doc phil
5/16/2016
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.
Robert J. Miller
5/16/2016
Just a quick comment on 510 K's. As someone who has helped submit a dental device to FDA for approval, I have walked this path. First, a 510 K is a "provisional" acceptance, and is the easiest FDA compliance to obtain. It is usually submitted in an application with predicate device(s), and is shown to be substantively similar to a device or material already granted approval. It has NOTHING to do with long term outcomes, and must undergo more rigorous testing and clinical trials to be granted full approval. Second, the FDA may review this provisional acceptance based on any and all reports with regard to it's safety and efficacy. It can even be revoked if they so choose. Third, all clinicians must make the final decision as to whether to use it ONLY for the procedures for which it has been granted approval, or to use it "off label" and risk the wrath of licensing authorities should it go south. But now, most importantly, 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? And why did this happen? Perhaps the failure and complication rate is much higher than they will admit. So this begs the next question.....if 100% Bio-Oss behaves more poorly than the equivalent allograft, alloplast, or even autogenous bone, then why use it at all? Now respond to my original statement that users of xenograft find "failure to resorb, fibrous encapsulation, foreign body reactions, low modulus of elasticity, late implant failures, and low to non-existent vascularity". Low percentage of vital bone in oral implantology makes absolutely no sense to me. RJM
doc phil
5/16/2016
"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?
Robert J. Miller
5/17/2016
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 (see Istvan Urban). They also recommend that Bio-Oss NOT be mixed with allograft. And why this movement towards mixing of graft types? Could it possibly be that their original bone graft of choice is not as effective as they would have hoped? And where are THEIR peer-reviewed papers when they suggest that these new protocols are superior? Don't know about everyone else, but I have a simple paradigm. I want to see 100% host bone when I reopen my grafted sites, NOT hamburger helper that we see with Bio-Oss grafts. That gives me the highest percentage of vital bone, highest percentage of bone-to-implant contact, highest stress bearing capacity, and best vascularity. This is a biologic approach, and one that gives me the best clinical outcomes I have been able to achieve in 31 years of oral implantology. For those who want to know what I use; autogenous bone in very small defects and pure phase bTCP hydrated with autologous serum for my larger defects. There is absolutely no reason for me to use a mixture of other graft types. And one last comment. Why is it that all of the other posters have links to their websites.....except you. Is there a conflict of interest here that you don't want us to know?......RJM
doc phil
5/17/2016
"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.

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