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FAQ
FAQ
Bond Apatite® is a composite graft, made of 3D Bond™ matrix mixed with HA granules in a controlled particle size distribution, intended to fill or augment a vast diversity of osseous defects.
Bond Apatite is a composite graft composed of 2/3 biphasic calcium sulfate cement matrices and 1/3 hydroxyapatite granules in different sizes and shapes.
No, the cement matrix within Bond Apatite ® is made of a pure calcium sulfate as a biphasic formulation. We did not add any additives, polymers or other chemicals, so the chemical structure of calcium sulfate was not changed at all. Its ability to be moldable and to harden instantly in the presence of blood or saliva of the biphasic formulation is due to the fact that the particles within the cement are partially crystalized and still maintain the ability to adhere and to set and harden. In that way, the cement is much more stable and has a predictable resorption behavior.
Bond Apatite® can be used in a wide diversity of osseous defects, including medium and large size defects such as dehiscence, fenestration cases, lateral augmentations (horizontal crest widening), small or medium sizes of sinus cavities, or as lateral bone window closure in some very large sinus cavities, periodontal bone defects, filling of bony defects pre-implant placement, or simultaneously with implant placement, filling a cavity post cyst removal, ridge augmentations, bone splits, etc.
Bond Apatite® is a composite graft made of Biphasic Calcium Sulfate and HA in a specific particle size distribution, in a ratio of 2:1. This combination takes advantage of each part of its components. Calcium sulfate acts a short-range space maintainer scaffold. It completely degrades in strict relation to the bone formation rate (4-10 weeks), while the HA acts as a long term space maintainer. The amount of HA within the graft is a relatively small proportion (33%), and is intended only to slow down the overall resorption of the graft. The bioactivity and the graft transformation into vital bone are due to the biphasic calcium sulfate, which is 66.6% of the graft.
The overall structure of Bond Apatite® has microporous (1-10μm) and macroporous (50-500μm). The initial surface porosity percentage is about 40 percent; however, since Calcium Sulfate completely degrades over time, it creates more space for the new bone to be formed.
No. After placing the cement in place and pressing above for setting and hardening, you should not. The graft porosity and its hygroscopic ability will allow blood to seep inside immediately.
The setting time is approximately 3-5 minutes.
Due to the cement properties, using a membrane is not needed in most of the clinical cases as long as primary soft tissue closure is achieved.
Using a membrane might be recommended in large size defects in which soft tissue stabilization cannot be ensured or in socket preservation procedure when a flap was not reflected and the material is completely exposed to the oral environment. In such cases, a protection barrier is required above the graft to prevent volume loss. (It can be a collagen sponge or a membrane that can be left exposed above the graft.)
NO – It is not recommended to leave the material exposed. Leaving the material exposed without a protection of a physical barrier can lead to material volume loss.
Nevertheless, leaving the material exposed with a gap of 1-3 mm is not an issue as soft tissue will migrate rapidly over it and will close the gap in a few days.
In socket grafting procedure, eject the material from its syringe into the socket, place a dry gauze above the material, and with your finger (or a spatula if there is not enough space for your finger), press firmly for 3 seconds then remove the gauze and close the flap in cases when you did not reflect a flap. In order to prevent volume loss, you must protect the exposed graft by physical barrier such as with an inexpensive collagen sponge or a membrane. Those can be left exposed, however; any such physical barrier must be well stabilized and sutured to the proximity soft tissue until the proliferation of the soft tissue above the graft will take place.
*When 4 bony walls exist, do not use any tool to push the cement into the bottom of the socket as you are used to with granules. Doing so might cause pain to the patient due to the cement expansion.
In small to medium size sinus cavities, Bond Apatite® can be used by itself. Small or medium-sized sinus cavities are cases when one or two syringes of Bond Apatite® can be sufficient for the entire procedure. In such cases, eject the material from its syringe through the crest direction into the sinus cavity and then place dry gauze above the material, place your finger above the gauze and press for 3 seconds, and then remove the gauze and close the flap. There is no need for membrane coverage. Additionally, in large sinus cavities when more than 2cc (2 syringes) are required, it is less comfortable to work just with Bond Apatite® because you will need to work by increment; therefore, we recommend you to fill 2/3 of the sinus cavity with your preferable granular augmentation material and the final 1/3 with Bond Apatite®. It will enrich the grafted site with calcium ions and will also close the sinus window. No additional need for a membrane is required.
It is very simple. Reflect the flap and prepare the site, with decortication or without, prepare and release the soft tissue for final coverage. Then, after graft activation, eject it into the augmented site, place a dry gauze pad above and press for 3 seconds and close the flap. There is no need for membrane as long as your soft tissue is primary closed and well sutured.
Bond Apatite® can be used for vertical augmentation only if you are already familiar with the material and experienced with vertical augmentation techniques. In such cases, a well-stabilized rigid protection barrier is always required.
Should I expect a different radiographic appearance than I am used to?
Due to the graft nature, the biphasic calcium sulfate matrix within the graft is simultaneously replaced by the patient’s own bone; therefore, the radiographic appearance is completely different compared to other grafts which always appears radiopaque due to their constant presence in the grafted site.
In contrary, the radiographic appearance with Bond Apatite® is as follows:
During day one after graft placement –it appears radiopaque.
Gradually, radiolucency appearance takes place (reflecting the graft transformation into the newly formed osteoid before its calcification).
2-4 weeks after graft placement, the majority of the grafted site will appear radiolucent while few radiopaque spots remain, reflecting the presence of the HA particles. Within 12 weeks, radiopacity takes place with the appearance of the native trabecular form. That is the time when the new osteoid has already calcified.
No, the material does not remain hard. The degradation process starts immediately after its placement while new bone formation simultaneously takes place.
The working time with the material starts when the powder is mixed with saline. At this time, the material is moldable and pliable for about 3 minutes (Working time). Thus, it is important to have the lesion fully prepared prior to the activation of the material. As soon as the material is placed in the defect, it should be compressed with a dry gauze pad for 3-5 seconds and then the material will harden in-situ immediately. At this point, you should proceed with primary soft tissue closure.
Keep in mind – your augmentation procedure should be done by 3 consecutive simple steps – place –press –close
And you should keep it as simple as it sounds. In less than a minute, your graft placement and stabilization can also be done in the most challenging cases.
Place the material into the grafted site, press above it with dry gauze for 3 seconds and close the flap.
(No need for a membrane, as long as your soft tissue is well sutured and primary closed)
* Passing the working time will influence the pliability and moldability of the material. The material can still be used, however, not with its cementing properties.
3D Bond™ is a cementable, osteoconductive bone substitute, made of pure Biphasic Calcium Sulfate; the only one of its kind that can set in the presence of blood and saliva. The material is completely resorbed within 4-10 weeks, coinciding with the time period it takes for the bone to form. The outcome is a complete replacement of the graft with the patient’s own bone.
The medical use of Calcium Sulfate has the longest history in the augmentation field, with over 120 years of use in the areas of Orthopedics, Plastics, Oncology, and Maxillofacial medicine. This material has been studied and documented most extensively and is the only one that is associated with thousands of articles in various areas of medical literature.
Throughout the years there has been a constant insistence on working with Calcium Sulfate due to the extraordinary features that distinguish it from currently existing augmentation materials. Notwithstanding, the material in its basic form has two prominent drawbacks; namely, its inability to harden as cement in the presence of blood and saliva existing in the oral environment and the materials fast resorption rate.
The development of 3D Bond™ originated from a clear clinical need to simplify the complexity of today’s augmentation procedures, shorten the working time as well as the recovery time. The development of this material was a process of over 15 years of intensive research, focusing on the use of pure raw material without any additives or accelerators. The outcome is a superior bone graft material that has the ability to set instantly in the presence of blood and saliva.
Biphasic calcium sulfate is a patented formulation of calcium sulfate. This is the only formulation of calcium sulfate that has the ability to behave as cement in the oral cavity. Additionally, the BCS is moldable and can set and harden instantly in the presence of blood and saliva. The old calcium sulfate could not set and harden when it got it to contact with blood or saliva; therefore, it could not be easily used as a suitable cement in the maxillofacial field.
Certainly. Combining 3D Bond™ with various granular bone substitutes enhances the overall quality of the graft and creates a composite cementable mixture. The granule type can be selected according to the clinician’s preference.
Nonetheless, for larger lesions that require the use of a long lasting space maintainer, it is recommended that the additional bone substitute chosen can address this requirement.
The initial setting time is approximately 3-5 minutes.
It is possible to extend the setting time by using a previously cooled saline liquid, although in our experience this is unnecessary.
Most certainly..
When 3D Bond™ is used on its own, the material is completely resorbed and replaced by the patient’s own bone, which is apparent while viewing an x-ray.
Approximately a week post-operation, a radiolucent shading in the circumference can be noticed in an x-ray. This shading will expand up to the fourth week when the entire area will be completely radiolucent. It seems as though the material has completely disappeared, but this is not the case. This is the un-calcified osteoid. Gradually, calcification of the area will take place, so that up to three months after implantation, the entire area will be radiopaque in the x-ray, with an identical appearance to the adjacent native trabecular bone.
Calcium sulfate is the most documented material for bone grafting in history, with over 120 years of literature behind it, and its safety has been proven beyond any doubt. Nevertheless, the clinician should review the User Manual in order to have the best performance.
Why with biphasic calcium sulfate bone cement the flap should be with tension and not tension free as with conventional bone grafting procedures?
With conventional bone grafting, tension free flap and primary closure are mandatory. Otherwise, the graft will get exposed, and we might end up with contamination and graft failure. The reason for that is because biologically soft tissue healing starts by retraction. Due to the fact that the interaction between the soft tissue and graft or membrane underneath doesn’t allow normal healing by proliferation, the flap will continue to retract, and the graft will get exposed. Thus, to compensate for this retraction, the surgical flap needs to be tension free.
The problem with tension-free surgical flap is that the soft tissue manipulation is more invasive, larger flaps are needed to expose the host site, and dissection of the flap compromises the blood supply, and the flap becomes connected to the muscles’ movement.s1 It requires higher surgical skills, and it is more traumatic to our patient, (swelling, pain, hematomas).
In contrary, calcium sulfate has impeccable synergy with soft tissue, and the ability to enable the quick and safe proliferation of the soft tissue over its surface without any risk of contamination during exposure due to the graft bacteriostatic nature. The stable structure of the biphasic calcium sulfate cement keeps that proliferation above the surface more predictably.
These characteristics of biphasic calcium sulfate enable our patients to benefit from less invasive surgical procedures; the procedure is fast and less complicated, and no involvement or influence of the muscles on the flap stability (the flap and the graft is kept stable during the healing phase). As a result of minimal flap reflection and lack of muscle involvement with the flap, post-operative pain is minimized, hematomas are practically not apparent and swelling is significantly reduced.
There is no need for higher soft tissue manipulation skills and experience while applying this graft material is extremely easy for us as clinicians.
All is needed is to reflect the flap only 3 mm beyond the MGJ to place the cement and stretch the soft tissue for closure (3 mm into the mobile mucosa will enable 6 mm stretching together with 3 mm of graft exposure we can have a potential 9 mm of horizontal width) which is sufficient for almost any horizontal volume loss.
It is a huge advantage for our patients and for us. Something that we didn’t have up until now.
Why with biphasic calcium sulfate bone cement the flap should be with tension and not tension free as with conventional bone grafting procedures?
With conventional bone grafting, tension free flap and primary closure are mandatory. Otherwise, the graft will get exposed, and we might end up with contamination and graft failure. The reason for that is because biologically soft tissue healing starts by retraction. Due to the fact that the interaction between the soft tissue and graft or membrane underneath doesn’t allow normal healing by proliferation, the flap will continue to retract, and the graft will get exposed. Thus, to compensate for this retraction, the surgical flap needs to be tension free.
The problem with tension-free surgical flap is that the soft tissue manipulation is more invasive, larger flaps are needed to expose the host site, and dissection of the flap compromises the blood supply, and the flap becomes connected to the muscles’ movement.s1 It requires higher surgical skills, and it is more traumatic to our patient, (swelling, pain, hematomas).
In contrary, calcium sulfate has impeccable synergy with soft tissue, and the ability to enable the quick and safe proliferation of the soft tissue over its surface without any risk of contamination during exposure due to the graft bacteriostatic nature. The stable structure of the biphasic calcium sulfate cement keeps that proliferation above the surface more predictably.
These characteristics of biphasic calcium sulfate enable our patients to benefit from less invasive surgical procedures; the procedure is fast and less complicated, and no involvement or influence of the muscles on the flap stability (the flap and the graft is kept stable during the healing phase). As a result of minimal flap reflection and lack of muscle involvement with the flap, post-operative pain is minimized, hematomas are practically not apparent and swelling is significantly reduced.
There is no need for higher soft tissue manipulation skills and experience while applying this graft material is extremely easy for us as clinicians.
All is needed is to reflect the flap only 3 mm beyond the MGJ to place the cement and stretch the soft tissue for closure (3 mm into the mobile mucosa will enable 6 mm stretching together with 3 mm of graft exposure we can have a potential 9 mm of horizontal width) which is sufficient for almost any horizontal volume loss.
It is a huge advantage for our patients and for us. Something that we didn’t have up until now.
How come maximal closure (3 mm of graft exposure) is acceptable and primary closure is not mandatory?
In our institutional (substitute “old”, or “classic” if one wants to feel better) surgical training, primary closure is the gold standard for a successful graft procedure. The reason for that is the fact that most graft materials are prone to bacterial contamination and infection. This complication will result in total graft loss and increased surgical morbidity for the patient. Most graft materials are particulate and unstable and thus require a containment device (mesh, membranes etc.) which are also prone to infection if exposed or tend to compromise blood supply to the healing host site if they are exposed. In fact, some of these containment elements (Teflon membranes, ti-mesh, ti-reinforced membranes etc.) by their nature, can CAUSE the exposure of the graft. Thus, primary closure is non-negotiable in these situations.
BCS Bone graft cements offer a paradigm shift here. The nature of the cement being its ability to adhere to the host site and harden is situ negates the need for containment devices in most augmented clinical cases, thus various membranes or meshes are not needed. The chemical salt structure has bacteriostatic abilities, and the bioactivity of the BCS cement generates a high calcium ion concentration enhancing bone formation and rapid soft tissue proliferation above the graft surface with minimal risk of contamination during exposure. Thus exposure of the graft material is irrelevant from the aspect of bacterial contamination. Due to these facts, primary closure is not necessary.
When the cement sets and if properly handled, as directed by our protocols, a continuous crystalline matrix is initially formed. This matrix (the set cement) is actually conducive for soft tissue propagation. Thus, even if exposed, the cement will allow the soft tissue to proliferate over its external surface, to achieve closure by secondary intention. Leaving an incision open more then 3mm will result in volume loss, since the cement dissolves, as part of its conversion to the bone, and too much of an opening will allow the material to escape.
Thus, the real reason we recommend maximal closure (if primary is impossible) is to protect the patient and the wound site. To allow you, the clinician, to efficiently and expeditiously conclude the procedure without unnecessary and irrelevant surgical aggression.