NanoGen (Bone Graft Material)- 2x1 gm

Material: Nanocrystalline Calcium Sulphate
The First Nanotechnology Based Bone Graft

Synthetic Bone Graft Material

Approvals: US FDA, Australian TGA, Indian DCGI

Made in USA

NanoGen is a proprietary product developed by Orthogen, LLC. Microcrystalline calcium sulfate is converted to grains of calcium sulfate (size range 200 to 900 nanometers), which are tightly compressed together to form granules in sizes ranging from 400 to 1000 microns. This unique microscopic structure imparts unique properties to the product. NanoGen undergoes controlled degradation over a period of 12 weeks as compared to 4 to 6 weeks for traditional calcium sulfate. As it degrades, it leads to the formation of calcium phosphate which is the main inorganic component of bone and which also serves as a stimulus for further bone regeneration. Osteoblasts attach to the calcium phosphate and deposit more bone in the defect.

Since NanoGen degrades over a controlled period as compared to traditional calcium sulfate, it provides the stimulation for bone regeneration over a much longer period. Hence robust bone regeneration is observed in defects grafted with NanoGen.

Because it is completely degradable, bone defects grafted with NanoGen are eventually completely replaced with regenerated vital bone. Research shows that availability of vital bone is important for the placement and eventual success of dental implants.

Product PackagingEach pack contains two (2) kits for two (2) patients each kit contains:

1 gram NanoGen.
1 vile of Saline(5 ml).

Oral Surgery
Post-extraction: Carefully pack the NanoGen putty into the defect after tooth extraction. Compress the putty to ensure complete filling of the socket.The site can be closed with any of the
commercially available GTR barrier membranes (calcium sulfate, collagen, absorbable polymer or ePTFE). The alveolus should be filled to slight excess and the soft tissue margins should be approximated with sutures over the barrier membrane.

Periodontics
Infra-osseous defects: After periodontal treatment, fill the defect(s) with NanoGen putty, pressing on the root surface. In furcations, NanoGen can be used alone or under membranes.

Endodontics
Apicoectomy: Fill the crypt with NanoGen putty. After the defect is completely filled, close it with a barrier membrane.

Root perforations: Introduce NanoGen putty into the pulp chamber. Push it through the perforation into the bone lesion until the latter is completely filled. Close the perforation with fast setting super-EBA or a resin bonding technique.


Open apices: Plug the apical third of the canal with NanoGen putty, then remove the material up to 1 mm from the radiographic apex. Fill the canal with your chosen technique.

Implantology
Dehiscence and fenestrations: Reconstruct the bone continuity with NanoGen putty. Close the defect with a GTR Barrier.

Mini sinus lifting: Prior to implant insertion, fill the bone area with NanoGen putty, pressing with an appropriate instrument and pushing the material so that the membrane is raised.

Great sinus lifting: NanoGen putty can be used as a single implant material for this purpose.IndicationsAs a stand-alone bone graft material

In combination with other bone graft materials

To provide a resorbable barrier over other bone graft materials

Biological Mechanisms of Calcium Sulfate Replacement by Bone:

Ricci J.L., Alexander H., Nadkarni P., Hawkins M., Turner J., Rosenblum S., Brezenoff L., DeLeonardis D., Pecora G. Bone Engineering, Edited By J. Davies; 2000; 332-344. This paper discusses how calcium sulfate is replaced by bone after being grafted in the bone defect.


Bone Regeneration With A Calcium Sulfate Barrier:

Gabriele Pecora., MD, Sebastiano Andreana, Joseph E. Margarone III, Ugo Covani, John S. Sottosanti. (Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1997;84:424-9).
This paper discusses the effective use of calcium sulfate as a barrier in female Sprague Dawley rats.
Link to Abstract: http://www.ncbi.nlm.nih.gov/pubmed/9347509


Bone Regeneration With Calcium Sulfate:

Evidence For Increased Angiogenesis In Rabbits. Strocchi R, Orsini G, Iezzi G, Scarano A, Rubini C, Pecora G. Journal of Oral Implantology 2002, 28, 5.

This study shows the significantly increased presence of micro blood vessels in defects that were grafted with calcium sulfate as compared to those grafted with autograft, indicating the angiogenic properties of calcium sulfate.
Link to Abstract: http://www.ncbi.nlm.nih.gov/pubmed/12498535


Migration of Human Gingival Fibroblasts Over Guided Tissue Regeneration Barrier Material:

Payne J, Cobb C, Rapley J, Killoy W, Spencer P. J Periodontol 1996;67:236-244.

This study discusses and compares the growth of fibroblasts on different barrier membranes (PLA, ePTFE or calcium sulfate) and shows that calcium sulfate is effective as a barrier membrane.
Link to Abstract: http://www.ncbi.nlm.nih.gov/pubmed/8708955


Response of a Calcium Sulfate Bone Graft Substitute in a Confined Cancellous Defect:

Walsh W., Morberg P., Yu Y., Yang Y, Haggard W., Sheath P, Svehla M, and Bruce W. J. M. Clinical Orthopedics and Related Research, 2003; 406: 228-236.

This paper discusses the molecular mechanism through which calcium sulfate acts as a bone graft. There was increased local acidity, which led to demineralization of the surface layer of surrounding bone. This led to release of growth factors into the bone defect, which further stimulated bone formation.
Link to Abstract: http://www.ncbi.nlm.nih.gov/pubmed/12579023 Features & Benefits Cost Effective
Completely Biodegradable
Osteoconductive
Guided Bone Regeneration Material
Encourages mineralization of newly generated bone.

Can be used Stand alone as well in Combination

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