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B-TCP Grafting Material: Predictable Results?

Posted By osseonews On May 29, 2011 @ 3:37 pm In Active Posts,Bone Grafting,Dental Implants Q&A | Comments Disabled

Dr. C asks:

Having only used allografts and autogenous grafts I am intrigued with some of the alloplastic products available. Are people using B-TCP as a sole grafting material? Can you expect predictable results using B-TCP for 4 and 3 walled defects? If you are using B-TCP is a barrier membrane required? What products of B-TCP are people using? I have heard of Fortoss Vital but I cannot find a distributer in the US to purchase it from. Is there a comparable product available in the US?


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#1 Comment By Dr. B On May 29, 2011 @ 6:25 pm

Wait for Dr. Peter fairbairn to come back on this topic. He has done hundreds of cases with alloplastic alone.
I wont comment much as i have only managed few on his recommendation.

besides vital. Easygraft is similar product.

steiner lab in us offer some product(i havent used them)

#2 Comment By Dr B On May 29, 2011 @ 6:33 pm

US Distributor for fortoss
Biocomposites Inc.
700 Military Cutoff Road, Suite 320
Wilmington, NC 28405, USA
Tel: 910-350-8015
Fax: 910-350-8072

#3 Comment By Dr.Alejandro Berg On May 31, 2011 @ 3:13 pm

I would say yes you can have predictable results , i use regularly Easygraft classic and the bifasic easygraft crystal for volume stability.This material needs no membrane, every granule is pre soaked in a polilactic acid barriere that is activated by the biolinker and in the pressence of water(blood) hardens very fast and keeps the form also avoids granule dispersal.
cheers

#4 Comment By Dr. C On May 31, 2011 @ 3:22 pm

Dr. Berg,

Thanks for the advice. But, Easygraft is not available for sell in the US. Do you know of a comparable product for sell in the US? Is Novabone or Fortoss Vital similar to Easygraft?

Dr. C

#5 Comment By Dr K. On May 31, 2011 @ 3:55 pm

If you want to try something that doesnt come in particles, but has putty consistency try ”Novabone putty”. It is not exactly TCP. It is bioglass, far superior to TCP. Has an effect similar to osteoconduction, called osseostimulation, that is FDA approved.I have had excellent results in 4wall def without membrane and 3walls with a membrane. What I love is that you can go in before 6 months and find excellent bone regeneration.

#6 Comment By Bruce GKnecht On May 31, 2011 @ 4:18 pm

I love using Curasan which is a B-TCP particulate. I will not say that it is my only graft material , but a majority of my cases are grafted with this. I have mixed Infuse with it and I have mixed PRG and PRP and liquid metronidozole mixtures. I love the stuff. I want a B-TCP block to be made that I can inject Infuse into. This is the future.

#7 Comment By John Manuel DDS On May 31, 2011 @ 4:35 pm

Pure Phase Beta-Tricalcium Phosphate, known as “SynthoGraft” by Bicon is designed for most graft needs, from trauma, and perio to e sinus floor, lateral sinus, periodontal, tooth sockets, osteotomies and socket preservation for implant placement.

It is designed with micro porosities which become filled with blood products as the surgeon vigorously whips patient blood (taken from the initial flap incision prior to full reflection). It even works fine if not placed until after the mix has clotted. It is placed and packed to a moderately stable shape with sterile cotton swabs.

If you have a healthy, intact periosteum with good surrounding attachment, no membrane is needed. Sometimes we place no membrane on the flap, but place a CollaPlug on the top of the implant.

Bicon uses saline irrigation only on the initial drill use since the others are 50 rpm with no irrigation. This gives you a pure, undiluted source of patient bone. Also, subsequent reamers have vertical slots which hold the removed bone which the surgeon easily slides off into a silicone dappen dish for use at the end of the surgery.

Usually, the SynthoGraft is used under the flap and the patient’s bone/blood mix from the reamers is placed on the top of the implant with a CollaPlug atop that to allow undisturbed bone healing.

Mixing antibiotics and other substances with the SynthoGraft or similar materials will alter the behavior. Acids will cause the synthetic graft to dissolve prematurely.

I used Freeze Dried Demineralized bone and other materials for decades, but no longer need them since the synthetic b-TCP handles all my needs along with the patient’s bone collected from the implant prep process.

If there is any possibility of the granules migrating, a bovine collagen membrane from Bicon is used and anchored to the periosteum by 5-0 chromic gut sutures in most cases. If there is a perforation of the sinus floor in a lift procedure, a “bag” is formed by the collagen membrane, filled with SynthoGraft/blood mix and the implant inserted into this “bag” as the bag is pushed up into the sinus floor with the implant’s sides holding it in place. A special sinus lift healing abutment is placed which precludes the implant itself from sliding too far into the sinus.

There are many webcasts of this on Bicon.com site.

#8 Comment By Dr. Taylor On May 31, 2011 @ 5:05 pm

Dear Dr. C,

B-tcp is an excellent choice for any osseous defect. It is a highly biocompatible, osteoconductive product that has no risk of disease transmission. Not to mention, most allograft products are gamma irradiated to the point that they are only osteoconductive, no bmp, which is what a b-tcp gives you, in a nutshell seek out a reputable company as your supplier for your practice. I recommend Synthes, I’ve had a lot of success with their products.

Cheers

#9 Comment By Dr. McLaughlin On May 31, 2011 @ 5:07 pm

Yes, use a membrane, graft cotainment+cell occlusion is still needed. I use Chronos b-tcp

#10 Comment By Idt On May 31, 2011 @ 6:15 pm

Cerasob is distributed in US. Has small and large size particles available. Must be mixed with blood. Still recommend using membrane or a calcium sulfate such as bone bond to protect graft. I prefer autogonous mixed with allograft or infuse for large defects. I find better bone quality on reentry. However btcp does work in those situations.

#11 Comment By Cd On May 31, 2011 @ 7:33 pm

4 wall defects heal on there own, anything will work, even patients own blood.

#12 Comment By Joe On May 31, 2011 @ 10:39 pm

Dr. Knecht,

B-tcp blocks already exist contact SYNTHES dentoalveolar division.

Enjoy!

#13 Comment By Dr Yahav amos On May 31, 2011 @ 11:26 pm

In order to gain the best results by our augmentation procedures we while use a graft which will give us the largest quantity of vital bone in the softest time . So we have to select a Biomaterials that will serve as a space maintainer as long as needed and will be transform into vital bone , the ultimate material for small defects that are not larger then 10 mm with at least 3 bony wall supports is the biphasic calcium sulfate ( the BondBone) which is the only calcium sulfat that can set insently in the present of blood or saliva and will totally resorb and replace by bone in the bone formation rate , so in 3 month you will have just vital bone , however in a larger defects with less bony wall supports we need a longer space maintainer so according the defect size you should combine the BB with other granules with slower resorption pattern ,by this combination you will improve significantly the handling and the outcome .it will give you the possibility that in 3 month you will contineu with your implant placement or rehabilitation .

#14 Comment By Greg Steiner On June 1, 2011 @ 2:54 am

There are three granular B-TCP products on the US market at this time. Synthograft, Cerasorb and our OsseoConduct. Synthograft is dense and non resorbable but does have micropores that prevents bacterial colonization. Cerasorb is a good B-TCP and resorbs in 7-24 months but has macropores which makes it contraindicated in sites that pose the possibility of bacterial colonization. OsseoConduct B-TCP has been FDA approved since October and is microporous to prevent bacterial colonization and is resorbed in 6 months. As more clinicians learn that allografts are not osteoinductive or osteogenic and produce sclerotic bone we believe the synthetic B-TCP’s will become a dominant graft material for many dental and skeletal surgeries. If you want a literature review of the research comparing B-TCP to autografts visit [1]. Greg Steiner Steiner Laboratories

#15 Comment By Wein On June 1, 2011 @ 5:14 pm

Mr. Steiner,

There are far more than three granular b-tcp products available in the US. Your are very misinformed and should stop posting nonsense.

#16 Comment By Greg Steiner On June 1, 2011 @ 5:47 pm

Hello Wein Please inform me of the additional b-tcp particulate products that have been approved for maxillo-facial applications in the US. I look forward to being informed and eliminating the nonsense rolling around in my head. A simple listing of the products may have been a more professional way to make your point but anyway no hard feelings and if I am misinformed I want to know it. I look forward to your reply. Dr. Greg Steiner

#17 Comment By Wein On June 1, 2011 @ 8:31 pm

Unlike you Dr Steiner, I have no agenda here, but you are grossly misinformed. Do your own homework!

#18 Comment By Greg Steiner On June 1, 2011 @ 9:51 pm

Hello again Wein I have done a bit of homework. In regard to b-tcp granules I did find ChronOS by Synthes. Does anyone know of other b-TCP granules on the US market in addition to synthograft, Cerasorb and OsseoConduct? Thanks Greg Steiner

#19 Comment By Joe On June 1, 2011 @ 10:33 pm

Dr. Steiner,

Congratulations, you fail

#20 Comment By Dr. Goldman On June 1, 2011 @ 10:37 pm

Dr. Steiner,

OsseoConduct is your product?

#21 Comment By Robert Teaegue On June 2, 2011 @ 3:35 am

Dear Dr C, Thanks for raising an interesting debate. For my part and unlike other respondents, I would wish to declare a commercial interest: I am Dental Director for Biocomposites, the UK manufacturer of Fortoss VITAL.

Our US affiliate, based in Wilmington, NC as correctly stated by Dr B, concentrates solely on the orthopaedic sector where a range of our synthetic biomaterials is marketed for bone grafting in spine and trauma cases. One of these, geneX is a larger volume orthopaedic equivalent of Fortoss VITAL

Fortoss VITAL, a composite dental bone grafting material containing Calcium Sulphate and Beta-tricalcium phosphate, has European CE and US FDA approval.

Like ALL Calcium Sulphate setting materials, irrespective of phases initially present (Calcium Sulphate hemihydrate and Calcium Sulphate dihydrate), when set, only one phase is present: the dihydrate phase. This is due to the setting being a hydration reaction. When set, Calcium Sulphate, alone or in combination, offers a soft tissue barrier function.

Tricalcium phosphate is available in only two forms: an alpha or beta form with alpha the faster resorbing of the two. Beta-tricalcium phosphate is subject to a range of manufacturing parameters (pore size, porosity, particle size, density, surface area, surface charge etc.,) and hence commercial specifications may display different clinical characteristics.

Clinicians should read the instructions for use (IFU) and other regulatory documents to familiarise themselves of a materials composition and recommended surgical technique, ie use of membrane. When applying a material outside of recommended surgical guidance, or in combination with other agents (eg antibiotics) clinicians should be aware that this would be considered as “off-label” and as such all responsibility is carried by the clinician themselves.

As with others I look forward to further contributions on this stimulating subject.

#22 Comment By Tim On June 2, 2011 @ 4:06 am

I’m a manufacturer of b-TCP, our focus has been (for the last 10 years, the spine fusion market. Are b-TCP blocks and wedges of value in the Dental Market? (USA)

#23 Comment By peter fairbairn On June 2, 2011 @ 4:35 am

Dear Dr.C and Dr May , sorry ,been away trying to do something really difficult ……get a small round ball into a hole , which is where Gary Players saying of the more I practice the luckier I become comes into play. This is true for implant dentistry as well.
For the last 8 years I have only used alloplast materials in all bone regeneration senarios from Defects , concavities , sinus augmentation , “peri-implantitis” , periodontal bone loss , cyst removal to restoration of the extremely resorbed maxillary ridge.

Things have moved on with these materials thanks to the Spinal and Orthopeadic surgeons , Genex (Vital )has been FDA approved for 10 years and hunderds of thousands of cases. So not new or radical in bone regeneration but not explored enough in Dental applications.
But the long term stability of the grafted sites is very impressive possibly due to never using autogenous bone .
Membrane free autogenous free is the way I have routinely worked for this period , this allows for increased blood supply to the graft site with improved regeneration and earlier loading even with bigger defects say 10mm by 8 mm. Even when the implant is only held by 1 or 2 threads and the rest is graft material we can load at 3 to 4 months .
Back to work..
Regards
Peter

#24 Comment By peter fairbairn On June 2, 2011 @ 5:55 am

Appologies , but that is using the materials to their extreme , best to start with easier cases and develop your skills. As to materials there are essentially 3 materials we use , Fortoss Vital ( Biocomposites ) , Easygraft ( Degradable Solutions ) and Bon Bone ( MIS Implants ) and they have differing uses and characteristics but essentially are all designed to use without a traditional membrane . They all stablise the graft in situ in different ways and prevent soft tissue ingrowth ( Easygraft may need a further CaSo4 barrier but is more stable and can beused in socket grafting where closure is not achievable ).
They can be used in combination in extreme cases , but alas not readilly available in the US as yet , but then you have BMPs which we do not ( although I saw in the IHT last Friday that there may be some major issues ahead ).
As to blocks they are in development presently..
I feel there is a future for these “old ” materials and with further development and technique refinement our results will improve.
Are they ideal ,no , but they allow us an abundant source (no need to harvest )of bio-compatible , bio-absorbable osseoconductive graft material. This certainly helps in patient acceptance of our treatment plans.
I will be showing cases at the 5 th Biomaterials Forum in Lucerne Switzerland on the 25 th of June , where the value of socket grafting , bone preservation is the area of debate.
Regards
Peter

#25 Comment By John Manuel DDS On June 2, 2011 @ 10:22 am

Dr. Steiner,

The research I have seen as well as my own experience with Synthograft b-TCP is that is resorbs completely and fairly rapidly, even as the sole component (other than patient blood mix).

There are micrographs in the research presentations on Bicon.com.

It is certainly true that membranes reduce the blood supply as mentioned above. Any time you can omit the collagen membrane between the periosteum and the particulate is a bonus situation. The Colla Plug “caps” can be sutured atop a graft site are great in that you can often omit the membrane below that, but still contain and protect the granules in the socket opening.

Also, if you can just hold the intact periosteum away and in the correct shape, as aforementioned, the body will build bone in a protected area (from intrusion).

John

#26 Comment By Greg Steiner On June 2, 2011 @ 3:34 pm

John Manuel

I will check that out and get back to you. This has turned into a very good discussion regarding the synthetics. Greg Steiner

#27 Comment By Greg Steiner On June 2, 2011 @ 3:48 pm

Joe
Thanks for the congradulations. I can assure you I fail more than anyone. Developing new products that work and new surgeries has produced more failures than we have time for here. But just as here the only way we we get better is to fail and learn and change. Greg Steiner

#28 Comment By Greg Steiner On June 2, 2011 @ 3:49 pm

Dr. Goldman
Yes, OsseoConduct is made by Steiner Laboratories. Greg Steiner

#29 Comment By Truth On June 6, 2011 @ 6:18 am

Please do not use any bovine unresorbable bone substitutes.

That is the wrong way.

#30 Comment By mike ainsworth On June 8, 2011 @ 4:15 pm

I Have been using B-Tcp products, vital and easygraft primarily, with bondbone as an adjunct sometimes for about 4 years, with excellent results. With vital there was a steep learning curve, due to the dry field needed for setting, but the results are fantastic. It is worth doing some research into these products and techniques, as they are the future. there may soon be no reasonable indications for autogenous bone, especially when the blocks come on line.

#31 Comment By Mr. Btcp On June 8, 2011 @ 4:46 pm

Btcp Blocks are available through synthes

#32 Comment By Dr. Weiss On June 8, 2011 @ 4:48 pm

What is purre phase btcp? Is that different from other btcp’s

#33 Comment By peter fairbairn On June 28, 2011 @ 10:03 am

There are two types of TCP alpha and Beta and we need the highest purity ( 99%) of Beta to acheive the benefits of the material as the alpha bio-absorbs too quicky leading to issues….
Peter

#34 Comment By TR On September 16, 2011 @ 10:14 am

I have severe bone loss on the lower right Jaw. Can BTCP or any other synthetic material be used to graft the bone for implants or any other material except my own bone?

#35 Comment By TR On September 18, 2011 @ 10:34 am

My question was in partcular to Dr Peter Fairbairn who I belive is regarded as authority on the issue and based in London where I am from.

#36 Comment By john On February 22, 2012 @ 6:29 pm

hi
i had a fusion in may 2010 of my L5-S1 it was done with hardware and VITOSS bone extender, my question is? the vitoss comes in foam strips and a bottle of bio active glass, for the product to work does the foam and boi active glass need to all be placed in the fusion area, also if it is installed with out the foam strips and extensively irrigated will it wash away the osteogenic cells and cause no fusion? only looking for an honest awnser. my dr and orthovita wont answer the question or emails about this.


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[1] : http://www.steinerlabs.com/research.shtml