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THE Graft is a natural, porous bone mineral matrix produced by removal of all organic components from porcine cancellous bone. Due to its natural structure, the anorganic bone mineral of THE Graft TM mimics the physical and chemical aspects of mineralized matrix of human bone. When packed into a bone defect, THE Graft TM gradually resorbs and is replaced with new bone during the healing process.
THE Graft TM is designed to mimic the structure of human bone, offering osteoconductive properties to host cell growth and complete remodeling to host bone. The natural structure of the anorganic bone mineral of THE Graft demonstrates similar physical and chemical characteristics compared to the mineralized matrix of human bone. THE Graft gradually resorbs and is replaced with host bone during the healing process. THE Graft is cancellous granules and is sterilized using gamma irradiation.
THE Graft TM Features & Benefits
THE Graft TM Clinical References
1. J Periodontal Implant Sci. 2017 Dec;47(6):388-401. Physicochemical characterization of porcine bone-derived grafting material and comparison with bovine xenografts for dental applications.
2. Ceramics International Volume 36, Issue 8, December 2010, Pages 2383-2393 Effect of the calcination temperature on the composition and microstructure of hydroxyapatite derived from human and animal bone, M. Figueiredo, A, Fernando, G. Martins, J. Freitas, F.Judas, H, Figueiredo
3. J Biomed Mater Res A. 2014 Oct;102(10):3609-17. doi: 10.1002/jbm.a.35022. Epub 2013 Nov 18. Osteogenic effect of low-temperature-heated porcine bone particles in a rat calvarial defect model., Go A1, Kim SE, Shim KM, Lee SM, Choi SH, Son JS, Kang SS.
In this study, low crystalline bone particles were obtained at low processing temperature (at temperature of 400°C) and achieved superior new bone formation compared with the high crystalline bone particles created at a higher process temperature (1200°C). It can be concluded that lower process temperature bone particles might provide a more effective graft material for enhancing bone formation.
4. Clin Implant Dent Relat Res 2018 Jul 27. Epub 2018 Jul 27. Alveolar ridge regeneration of damaged extraction sockets using deproteinized porcine versus bovine bone minerals: A randomized clinical trial. 100 patients
It is therefore suggested that DBBM (deproteinized bovine) and DPBM (deproteinized porcine) can be similarly used for grafting in damaged extraction sockets that lack bony walls.
5. Clin Implant Dent Relat Res. 2017; 19(1):140-150 Randomized Clinical Trial of Maxillary Sinus Grafting using Deproteinized Porcine and Bovine Bone Mineral. 16 Patients
The results suggested that DPBM might produce comparable bone formation and volumetric stability with DBBM in maxillary sinus grafting, however, further clinical study with longer‐term periods and larger sample sizes should be needed for confirming this suggestion.
6. Journal of Microbiology 52.2 (2016): 140-147. “Process development of a virally-safe dental xenograft material from porcine bones.” The Korean Journal of Microbiology 52.2 (2016): 140-147.
The Graft Sample Cases
Case 1 Extraction Socket
Case 2 Dehiscence Defect
A 65-year old female patient who had an abscess and discomfort on chewing associated with tooth #46, presented to the clinic for implant placement. #46 was extracted and a plug was applied, for rapid healing of soft tissue, followed by suture placment. The Graft was used a bone graft material without using a membrane. Upon re-entry surgery, adequate volume of newly formed bone was seen that could sufficiently support the implant on the buccal aspect. 3-year post-operative CT Scan revelaed a complete replacement of defected bony lesion into compact and cancellous bone due to grafting with The Graft.
|Questions and Answers|
Porosity is an important factor in determining tissue-implant material integration. High porosity leads to a quicker absorption of liquids and cells spreading. THE Graft™ provides the optimized bone architecture for cells adhesions and tissue regeneration. \> The porosity of THE Graft was found to be 78.4%, which is larger than that of both Bio-Oss® and Cerabone®. Considering the comparable porosity of human trabecular bone (79.3%), this result suggests that THE Graft resembles the porous structure of human bone quite closely. 1 \*\*Porosity Chart\*\*
\*\*Wetting mass of the graft materials as a function of time.\*\*
J Periodontal Implant Sci. 2017 Dec;47(6):388-401. https://doi.org/10.5051/jpis.2017.47.6.388 Copyright © 2017. Korean Academy of Periodontology
Yes. The Graft is processed using proprietary virus inactivation process technology. Thanks to highly efficient manufacturing process, THE Graft™ is free from any organic components that might be potential causes of infection or immune reaction. This unique process preserves most of the physical properties of the native porcine osseous structure of THE Graft™.
Bio-Oss ® is a product from Geistlich that is bone substitute sourced from bovine. It is known as a DBBM or deproteinized bovine bone material. The GRAFT, on the other hand, is a DPBM, or a deproteinized porcine bone material. There have been several studies that compared bovine (i.e. Bio-Oss), and porcine (i.e. The GRAFT) bone substitutes. Overall the studies show that both types of graft are equally viable materials. "Considering that both bovine bone grafting materials have been successfully used in oral surgery applications in the last few decades, this work shows that the porcine-derived grafting material possesses most of the key physiochemical characteristics required for its application as a highly efficient xenograft material for bone replacement." 1,2 The benefit of a porcine-derived bone substitute, like The Graft ® vs a bovine-derived substitute (Bio-Oss), is that studies have shown that the porcine bone has a higher Hydrophilicity and Porosity than comparable bovine bone. These properties suggest advantages of porcine bone as a grafting material. Numerous studies have shown that attachment, growth, and proliferation of various types of cells, including osteoblasts, have been reported to be significantly affected by the "wettability" of the material surface.
Yes. The Graft received a 510-K Class 2 clearance by the FDA in June 2018. You can download the \[FDA notification here]\(https://www.accessdata.fda.gov/cdrh\_docs/pdf17/K173188.pdf). \*\*References\*\* 1\. J Periodontal Implant Sci. 2017 Dec;47(6):388-401. \[Physicochemical characterization of porcine bone-derived grafting material and comparison with bovine xenografts for dental applications.]\(https://www.jpis.org/search.php?where=aview&id=10.5051/jpis.2017.47.6.388&code=1150JPIS&vmode=FULL) 2\. Clin Implant Dent Relat Res 2018 Jul 27. Epub 2018 Jul 27. \[Alveolar ridge regeneration of damaged extraction sockets using deproteinized porcine versus bovine bone minerals: A randomized clinical trial. 100 patients]\(https://onlinelibrary.wiley.com/doi/full/10.1111/cid.12628)
\[The Graft Bone Substitute]\(https://www.ddsgadget.com/the-graft-bone-substitute.html) is a natural and porous bone mineral matrix available in cancellous granules. It is manufactured by removal of most organic components from porcine bone.
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