To cover or not to cover a grafted socket?

If we have an extraction socket with 4 walls and do nothing, we have to wait 6 to 8 months to place an implant and there will be bone loss vertical and horizontally. I use bone graft with A-PRF to cover the extraction site and then we can place the implant in 3 months. IF I have a 4 walls socket I use A-PRF PLUGS alone with the same excellent results. A-PRF plugs are easy to make and takes only 8 minutes.

have you tried A-PRF membranes to close the grafted socket? you do not have to perform primary closure. The membranes can be exposed and save you time and bone loss that happens when you open a flap to try primary closure. Such pressure on the site causes at least 2 mm of bone resorption and it can be avoided with the use of A-PRF.

Peter, I just viewed a video on Easy Graft. It seems to harden quite quickly to a rock-hard consistency. It would appear that suturing is not possible...am I correct, or if not it would appear that you have to move extremely rapidly with suturing.I appreciate your input. Thanks

Easy Graft is simply a mixture of b-TCP and HA or just b-TCP (classic version). There is nothing magical or unique about it. There are many b-TCP and HA graft products on the market. For example, CeraSorb is b-TCP. The issues with these grafts, especially b-TCP are well known. If you are interested in a synthetic graft, a good choice, in my opinion, is OsteoGen. It's been in use for 30 years. Basically, it's a synthetically-derived non-ceramic form of hydroxylapatite (HA), but the process to make it yields a process yields a unique Ca:P ratio. Anyway, too much for a post here. Just wanted to point out that there is alot of marketing jargon thrown around when it comes to synthetic grafts, but most of the materials in these products are the same, even if the way they are mixed does, in theory, change the clinical effectiveness.

Dear Phil, As Peter F says easy-graft is not the same as cerasorb. With easy-graft the biomaterial is coated with a polymer. When softened by the supplier biolinker this polymer allows the graft to be mouldable and stick to its neighbour. Removal of the biolinker by blood in the site causes the polymer to re-harden. This in situ hardening creates stability and containment in the type of site described. This process can be controlled. More pressure on the graft and or irrigation quickens things up if needed. As such the hardening is in the clinicians hands. easy-graft can be left exposed as described by Peter. The stability remains for around 2 weeks after which a clot will be stabilised and early soft tissue coverage in place. This healing is nicely documented in the recent work by Leventis. Robert Teague

Robert, Easy-Graft was approved for sale in the US via a 510-K, because it was substantially equivalent to several other predicate devices, one of which is Cerasorb. You can read the FDA filing yourself here, it includes all the predicate devices: http://www.accessdata.fda.gov/cdrh_docs/pdf13/K131385.pdf Of course, there are differences between Easy-Graft and other other predicate devices, but these differences aren't considered relevant by anyone, or else Easy-Graft wouldn't have gotten approved via a 510-K, nor would the owners of Easy-Graft have sought a 510-K in the first place. If the differences in Easy-Graft were relevant, Easy-Graft would need to have gotten at least a PMA which requires controlled human studies to get approval, which it doesn't have. Once again, approval by 510-K by definition means that the device is substantially equivalent to predicate devices, so obviously you can't claim otherwise, or else you can't market the device under a 510-K (you would need at least a PMA).

I would also add that the biolinker in Easy-Graft is simply water and N-methyl-2-pyrrolidone (NMP). N-methyl-2-pyrrolidone has been in use for over a decade in medical products. Basically, Easy-Graft is ß-TCP coated with PLGA and mixed with NMP and water. It's all there in the 510-K. Everyone can read it themselves. By the way, I'm not knocking Easy-Graft. I'm sure it's a good product with good results. But, it uses the same stuff as many other products on the market, just in a different combination. It's basically, as far as I can tell, an attempt to improve the performance of B-TCP by coating it with PLGA and mixing it with NMP. I like the idea alot of mixing these materials and the PLGA coating. But it still provides no basis for claiming that Easy-Graft's new B-TCP formulation is clinically different than other B-TCP's on the market, like Cerasorb. Nor would the company ever make that claim, or else the FDA would be all over them and require a PMA. What is ironic concerning this whole discussion, is that I believe the marketer of Easy-Graft in the US, is Sunstar, and Sunstar also markets a membrane called GUIDOR® Bioresorbable Matrix Barrier.

"There is a newer membrane called OssixPlus that is now available in the USA……it is a porcine collagen membrane." There are already several cross-linked porcine collagen membranes available in the US (BioGide is non-crosslinked). I don't see anything unique really about OssixPlus, even though I'm sure it's a fine membrane. One of the leading companies in dental for collagen membranes is Collagen Matrix Dental. They actually make the membranes that most dentists use, even if dentists don't realize Collagen Matrix makes them because they are private labeled. Presently, Collagen Matrix also has a line of membranes they sell direct to dentists, called MatrixDerm. It is highly purified type I and III collagen derived from intact porcine dermis (it is cross-linked). There are several different types of MatrixDerm.

I forgot to mention that basically any new collagen membrane approved in the US, will by definition not be unique as they are approved by the FDA (510-K), precisely because they are "substantially equivalent to legally marketed predicate devices", to use FDA phraseology. Essentially, the technology behind manufacturing quality and effective collagen membranes is already well understood, and there really is not much innovation anymore in this area. Of course, there are slight differences between all the membranes out there, but I'm not sure the differences are all that clinically significant, nor are there any statistically significant human studies to demonstrate clinical significance. As mentioned above, all these membranes are approved via a 510-K filing, which simply implies that they are equivalent to the other products already on the market.

A-PRF membranes can be left exposed, so no primary closure is necessary nor the use of porcine materials. We obtain excellent results mixing some of the membranes fragments with allograft material and using A-PRF membranes to cover the graft. We do not have to wait 6-8 months to place and implant, now is only 3 months wait.

Peter, sure I agree with you to an extent. Experience is everything and obviously there is a slight difference in all these synthetics that can produce different clinical results in practice. In theory, it's similar to the known effect of generic vs brands in pharmaceuticals. It is a well-known fact that patients will react differently to brands and generics, even if in theory they are the same thing chemically. That being said, the reality is that all these synthetic grafts (and types of membranes) are approved in the US via 510-K due to the substantial equivalence guideline, so by definition all the products are from a clinical perspective/result exactly the same. If they were different they would not get approved, and the manufacturers would need to seek a more extensive approval process with real trials (i.e. controls, statistical significance), which they never do in dentistry. I think in the end, clinicians need to use what they are comfortable with, and in their experience has worked. There are a vast array of materials that will work because the materials and science are all already well understood. Really it all depends on specific circumstances and the different techniques clinicians employ. Here in the US for example, allograft is abundant and doctors have had successful experience using it, so I think it's pretty much a given that allograft will be preferred in the US over other materials. Over in Europe, I believe that allograft is not widely available or even permitted in many countries, so obviously alloplasts (synthetics) and xeongrafts will prove more popular. Since the success rate of implants (and failure) appears to be exactly the same on both continents, I'm led to conclude that all these materials will work fine under the right clinician. Probably best to mix some of the materials together, which many do in the US (e.g. Dentogen (calcium sulfate hemihydrate) + Allograft).

Completely agree CRS. But, you need to remember that in many parts of the world, allograft is not widely available, and/or it is not allowed. So doctors need an alternative. The US is quite unique in regards to the wide availability of quality allograft.

Now I finally understand, did not realize materials not allowed or available. Thanks I was racking my brain trying to figure out why practitioners would seemingly prefer synthetic over human. I just don't get the same results and thought I was doing something wrong. Thank you for this insight. It is always helpful to compare.

Please note that as of September, 2015, OSSIX PLUS has been available for use in Canada. An earlier comment mentioned that they were awaiting regulatory approval. http://hesiramed.com/collections/all

A-PRF membranes and plugs are the newest alternative. Is autologous, takes only 8 minutes and the cost to the doctor is about 2 to 12 dollars per patient.

No experience with EasyGraft or Nu-Oss, so can't comment, other than to say that EasyGraft is apparently b-TCP + HA or just b-TCP alone. These are well known synthetic materials, and if Peter likes EasyGraft, I'm sure it's good. Nu-Oss is a xenograft, I believe, made from bovine. Similar to Bio-Oss. Collagen Matrix, also just introduced a similar type of xenograft called MatrixOss . In terms of Membranes, MemLock is type I collagen (reconstituted) from Bovine. MemLock is supposed to resorb in 6 to 9 Months, according to BioHorizons. I'm sure it's a fine membrane. If you are looking at a longer resorption collagen membrane or if you just want to get a sense of different collagen membranes and prices, I'd highly recommend to look at Collagen Matrix Membranes (MatrixDerm, MatrixFlex, MatrixMem). These are excellent membranes, and you may save some money. Collagen Matrix is a very well regarded leader in collagen membrane manufacturing, and they manufacture/private label membranes for many large implant companies and distributors. MatrixDerm is their direct-to-dentist brand and it's manufactured slightly differently than other membranes. They also have an extended resorption membrane called, MatrixDerm EXT, and a pre-shaped membrane for extraction sockets called MatrixDerm Cap.

Thank you for the advice. Will have to give these a try.

Hi Greg, I'm confused by your response. Are you saying that your grafting products have a PMA from the FDA? Because if you didn't get a 510-K, you would need a PMA. Can you please refer us to your PMA filing? And if you went thru the FDA drug division, are you saying you did Phase I, II, III trials for approval? By the way, there is nothing wrong with using bone grafting products and membranes that are substantially equivalent to predicate devices and that are similar to other products on the market. In fact, as clinicians we should only use products that, at least until now, are similar to other products that have already been proven safe and effective via years of experience. Otherwise, we should demand controlled human studies before using "new" products. Of course, the marketing department always needs something new to make sales, and I have nothing wrong with that, it allows for some interesting new mixtures of proven materials, but people shouldn't be deluded from a clinical perspective.

Slightly harsh on xenografts considering the amount of research available on them. Yes they resorb slowly but there is a lot to said for their implant success rate especially in the sinus. Buses has literature with a 5-9 year follow up using xenografts with a 95%+ success rate. They are shown to keep the dimensional stability of the socket whilst providing the volume maintenance required to have long term implant success rate. I'd do some more research on these materials before disregarding them so quickly.

It looks like many of you forgot the main question: "cover or not cover a graft?"