Bone Regeneration Using an Alloplastic Graft Material that Combines β Tricalcium Phosphate and Calcium Sulphate: A Case Series Report with Histology

Main Article Content

Dominic O’Hooley, BDS Peter Fairbairn, BDS Stuart Kilner, BDS Robert A. Horowitz, DDS Gregori M. Kurtzman, DDS

Abstract

This retrospective case series reports on the use of an established alloplastic bone product composed of a 65:35 ratio of β Tricalcium Phosphate and Calcium Sulphate to facilitate host bone regeneration in a variety of intra-oral sites and clinical indications. The study involved seven patients treated by seven different clinicians operating at five geographical sites. All cases included trephined bone cores harvested at 12 and 33 weeks. These cores were subject to histological analysis using standardized protocols at six separate laboratories. The primary measured outcome was the percentage of residual graft, new bone, and connective tissue at the measured time points. The results of this case series suggest that the alloplastic bone product is 50% resorbed and replaced by new host bone at 12 weeks, with further consistent resorption to 85% at 33 weeks. These results suggest that this alloplastic product can be successfully used in a wide variety of intra-oral bone grafting protocols leading to consistent resorption of the material and its replacement with new host bone, independent of clinician and established histological analytical protocol used.

Keywords: beta tricalcium phosphate, calcium sulphate, socket grafting, delayed implant placement

Article Details

How to Cite
O’HOOLEY, Dominic et al. Bone Regeneration Using an Alloplastic Graft Material that Combines β Tricalcium Phosphate and Calcium Sulphate: A Case Series Report with Histology. Medical Research Archives, [S.l.], v. 12, n. 8, aug. 2024. ISSN 2375-1924. Available at: <https://esmed.org/MRA/mra/article/view/5660>. Date accessed: 06 sep. 2024. doi: https://doi.org/10.18103/mra.v12i8.5660.
Section
Case Series

References

1. Kamijou T, Nakajima T, Ozawa H. Effects of osteocytes on osteoinduction in the autogenous rib graft in the rat mandible. Bone. 1994 Nov-Dec; 15(6):629-37. doi: 10.1016/8756-3282(94)90311-5. PMID: 7873292. Schallhorn RG. Long term evaluation of osseous grafts in periodontal therapy. Int Dent J. 1980 Jun;30(2):101-16. PMID: 6997214.

2. Cardaropoli D, Tamagnone L, Roffredo A, De Maria A, Gaveglio L. Preservation of Peri-implant Soft Tissues Following Immediate Postextraction Implant Placement. Part II: Clinical Evaluation. Int J Periodontics Restorative Dent. 2019 Nov/Dec;39 (6):789-797. doi: 10.11607/prd.4318. PMID: 31613939.

3. Beck TM, Mealey BL. Histologic analysis of healing after tooth extraction with ridge preservation using mineralized human bone allograft. J Periodontol. 2010 Dec;81(12):1765-72. doi: 10.1902/jop.2010.1 00286. Epub 2010 Jul 27. PMID: 20653437.

4. Zampara E, Alshammari M, De Bortoli J, Mullings O, Gkisakis IG, Benalcázar Jalkh EB, Tovar N, Coelho PG, Witek L. A Histologic and Histomorphometric Evaluation of an Allograft, Xenograft, and Alloplast Graft for Alveolar Ridge Preservation in Humans: A Randomized Controlled Clinical Trial. J Oral Implantol. 2022 Dec 1;48(6): 541-549. doi: 10.1563/aaid-joi-D-21-00012. PMID: 35446950.

5. Rodriguez AE, Nowzari H. The long-term risks and complications of bovine-derived xenografts: A case series. J Indian Soc Periodontol. 2019 Sep-Oct;23(5):487-492. doi: 10.4103/jisp.jisp_656_18. PMID: 31543624; PMCID: PMC6737859.

6. Lutz R, Neukam FW, Simion M, Schmitt CM. Long-term outcomes of bone augmentation on soft and hard-tissue stability: a systematic review. Clin Oral Implants Res. 2015 Sep;26 Suppl 11:103-22. doi: 10.1111/clr.12635. PMID: 26385626. Cannizzaro G, Felice P, Leone M, Viola P, Esposito M. Early loading of implants in the atrophic posterior maxilla: lateral sinus lift with autogenous bone and Bio-Oss versus crestal mini sinus lift and 8-mm hydroxyapatite-coated implants. A randomised controlled clinical trial. Eur J Oral Implantol. 2009 Spring;2(1):25-38. PMID: 20467616.

7. Bannister SR, Powell CA. Foreign body reaction to anorganic bovine bone and autogenous bone with platelet-rich plasma in guided bone regeneration. J Periodontol. 2008 Jun;79(6):1116-20. doi: 10.1902/jop.2008.060475. PMID: 18533792.

8. Scolozzi P, Perez A, Verdeja R, Courvoisier DS, Lombardi T. Association between maxillary sinus fungus ball and sinus bone grafting with deproteinized bovine bone substitutes: a case-control study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2016 Jun; 121(6):e143-7. doi: 10.1016/j.oo oo.2016.01.022. Epub 2016 Feb 13. PMID: 2697 2422.

9. Jensen T, Schou S, Stavropoulos A, Terheyden H, Holmstrup P. Maxillary sinus floor augmentation with Bio-Oss or Bio-Oss mixed with autogenous bone as graft in animals: a systematic review. Int J Oral Maxillofac Surg. 2012 Jan;41 (1):114-20. doi: 10.1016/j.ijom.2011.08.010. Epub 2011 Oct 13. PMID: 22000958..

10. Nappe, C., Rezuc, A., Montecinos, A., Donoso, F., Vergara, A., & Martinez, B. (2016). Histological comparison of an allograft, a xenograft and alloplastic graft as bone substitute materials. Journal of Osseointegration, 8(2), 20–26.

11. Kim Y, Nowzari H, Rich SK. Risk of prion disease transmission through bovine-derived bone substitutes: a systematic review. Clin Implant Dent Relat Res. 2013 Oct;15(5):645-53. doi: 10.1111/j.17 08-8208.2011.00407.x. Epub 2011 Dec 15. PMID: 22171533.

12. Kim Y, Rodriguez AE, Nowzari H. The Risk of Prion Infection through Bovine Grafting Materials. Clin Implant Dent Relat Res. 2016 Dec;18(6):1095-1102. doi: 10.1111/cid.12391. Epub 2016 Feb 8. PMID: 26856530.

13. Gill S, Prakash M, Forghany M, Vaderhobli RM. An ethical perspective to using bone grafts in dentistry. J Am Dent Assoc. 2022 Jan;153(1):88-91. doi: 10.1016/j.adaj.2021.09.011. PMID: 34996535.

14. https://www.linkedin.com/pulse/2023-2028-dental-bone-graft-substitutes-market/

15. Bohner M, Santoni BLG, Döbelin N. β-tricalcium phosphate for bone substitution: Synthesis and properties. Acta Biomater. 2020 Sep 1;113:23-41. doi: 10.1016/j.actbio.2020.06.022. Epub 2020 Jun 19. PMID: 32565369.

16. Tebyanian H, Norahan MH, Eyni H, Movahedin M, Mortazavi SJ, Karami A, Nourani MR, Baheiraei N. Effects of collagen/β-tricalcium phosphate bone graft to regenerate bone in critically sized rabbit calvarial defects. J Appl Biomater Funct Mater. 2019 Jan-Mar;17(1):2280800018820490. doi: 10.1177/2280800018820490. PMID: 30832532.

17. Ariizumi, T. , Kawashima, H. , Hatano, H. , Yamagishi, T. , Oike, N. , Sasaki, T. , Umezu, H. , Xu, Y. , Endo, N. and Ogose, A. (2019) Osteoinduction and Osteoconduction with Porous Beta-Tricalcium Phosphate Implanted after Fibular Resection in Humans. Journal of Biomaterials and Nanobiotechnology, 10, 159-173. doi: 10.4236/ jbnb.2019.103009.

18. Ishikawa K, Miyamoto Y, Tsuchiya A, Hayashi K, Tsuru K, Ohe G. Physical and Histological Comparison of Hydroxyapatite, Carbonate Apatite, and β-Tricalcium Phosphate Bone Substitutes. Materials (Basel). 2018 Oct 16;11(10):1993. doi: 10.3390/ma11101993. PMID: 30332751; PMCID: PMC6213161..

19. Coetzee AS. Regeneration of bone in the presence of calcium sulfate. Arch Otolaryngol. 1980 Jul;106(7):405-9. doi: 10.1001/archotol.1980.0079 0310029007. PMID: 7387528.

20. Aquino-Martínez R, Angelo AP, Pujol FV. Calcium-containing scaffolds induce bone regeneration by regulating mesenchymal stem cell differentiation and migration. Stem Cell Res Ther. 2017 Nov 16;8(1):265. doi: 10.1186/s13287-017-0713-0. PMID: 29145866; PMCID: PMC5689169.

21. Ricci, John (Jack) & Alexander, Harold & Nadkarni, P. (2000). Biological mechanisms of calcium sulfate replacement by bone. Bone Engineering. 332-344.

22. Pförringer D, Harrasser N, Mühlhofer H, Kiokekli M, Stemberger A, van Griensven M, Lucke M, Burgkart R, Obermeier A. Osteoinduction and -conduction through absorbable bone substitute materials based on calcium sulfate: in vivo biological behavior in a rabbit model. J Mater Sci Mater Med. 2018 Jan 9;29(2):17. doi: 10.1007/s10856-017-6017-1. PMID: 29318379.

23. Yuan H, Fernandes H, Habibovic P, de Boer J, Barradas AM, de Ruiter A, Walsh WR, van Blitterswijk CA, de Bruijn JD. Osteoinductive ceramics as a synthetic alternative to autologous bone grafting. Proc Natl Acad Sci U S A. 2010 Aug 3;107(31): 13614-9. doi: 10.1073/pnas.1003600107. Epub 2010 Jul 19. PMID: 20643969; PMCID: PMC2922269.

24. Miron RJ, Zhang Q, Sculean A, Buser D, Pippenger BE, Dard M, Shirakata Y, Chandad F, Zhang Y. Osteoinductive potential of 4 commonly employed bone grafts. Clin Oral Investig. 2016 Nov;20(8):2259-2265. doi: 10.1007/s00784-016-1724-4. Epub 2016 Jan 27. PMID: 26814714.

25. Chen Y, Wang J, Zhu XD, Tang ZR, Yang X, Tan YF, Fan YJ, Zhang XD. Enhanced effect of β-tricalcium phosphate phase on neovascularization of porous calcium phosphate ceramics: in vitro and in vivo evidence. Acta Biomater. 2015 Jan;11:435-48. doi: 10.1016/j.actbio.2014.09.028. Epub 2014 Sep 22. PMID: 25246313.

26. Artzi Z, Weinreb M, Givol N, Rohrer MD, Nemcovsky CE, Prasad HS, Tal H. Biomaterial resorption rate and healing site morphology of inorganic bovine bone and beta-tricalcium phosphate in the canine: a 24-month longitudinal histologic study and morphometric analysis. Int J Oral Maxillofac Implants. 2004 May-Jun;19(3):357-68. PMID: 15214219.

27. Fairbairn P, Leventis M. Protocol for Bone Augmentation with Simultaneous Early Implant Placement: A Retrospective Multicenter Clinical Study. Int J Dent. 2015;2015:589135. doi: 10.1155/2015/589135. Epub 2015 Nov 24. PMID: 26858757; PMCID: PMC4672140.

28. Leventis MD, Fairbairn P, Dontas I, Faratzis G, Valavanis KD, Khaldi L, Kostakis G, Eleftheriadis E. Biological response to β-tricalcium phosphate/ calcium sulfate synthetic graft material: an experimental study. Implant Dent. 2014 Feb;23(1):37-43. doi: 10.1097/ID.0000000000000030. PMID: 24384743.

29. Ruga E, Gallesio C, Chiusa L, Boffano P. Clinical and histologic outcomes of calcium sulfate in the treatment of postextraction sockets. J Craniofac Surg. 2011 Mar;22(2):494-8. doi: 10.1097/SCS.0b0 13e318208bb21. PMID: 21403526.

30. Eleftheriadis E, Leventis MD, Tosios KI, Faratzis G, Titsinidis S, Eleftheriadi I, Dontas I. Osteogenic activity of β-tricalcium phosphate in a hydroxyl sulphate matrix and demineralized bone matrix: a histological study in rabbit mandible. J Oral Sci. 2010 Sep;52(3):377-84. doi: 10.2334/ josnusd.52.377. PMID: 20881329.

31. Podaropoulos L, Veis AA, Papadimitriou S, Alexandridis C, Kalyvas D. Bone regeneration using beta-tricalcium phosphate in a calcium sulfate matrix. J Oral Implantol. 2009;35(1):28-36. doi: 10.1563/1548-1336-35.1.28. PMID: 19288885.

32. Anson D. Using calcium sulfate in guided tissue regeneration: a recipe for success. Compend Contin Educ Dent. 2000 May;21(5):365-70, 372-3, 376; quiz 378. PMID: 11199672.

33. Sukumar S, Drízhal I, Bukac J, Paulusová V, Pilathadka S. Surgical treatment of periodontal intrabony defects with calcium sulphate in combination with beta tricalcium phosphate--a 12-month retrospective clinical evaluation. Acta Medica (Hradec Kralove). 2010;53(4):229-34. PMID: 21400982.

34. Leventis MD, Fairbairn P, Dontas I, Faratzis G, Valavanis KD, Khaldi L, Kostakis G, Eleftheriadis E. Biological response to β-tricalcium phosphate/ calcium sulfate synthetic graft material: an experimental study. Implant Dent. 2014 Feb;23 (1):37-43. doi: 10.1097/ID.0000000000000030. PMID: 24384743.

35. Fairbairn P, Leventis M, Mangham C, Horowitz R. Alveolar Ridge Preservation Using a Novel Synthetic Grafting Material: A Case with Two-Year Follow-Up. Case Rep Dent. 2018 Feb 1;2018: 6412806. doi: 10.1155/2018/6412806. PMID: 29487751; PMCID: PMC5816876.

36. Cheah CW, Al-Namnam NM, Lau MN, Lim GS, Raman R, Fairbairn P, Ngeow WC. Synthetic Material for Bone, Periodontal, and Dental Tissue Regeneration: Where Are We Now, and Where Are We Heading Next? Materials (Basel). 2021 Oct 15;14(20):6123. doi: 10.3390/ma14206123. PMID: 34683712; PMCID: PMC8537464.

37. Horowitz R, Holtzclaw D, Rosen PS. A review on alveolar ridge preservation following tooth extraction. J Evid Based Dent Pract. 2012 Sep;12(3 Suppl):149-60. doi: 10.1016/S1532-3382(12)70029-5. PMID: 23040345.

38. Hansson S, Halldin A. Alveolar ridge resorption after tooth extraction: A consequence of a fundamental principle of bone physiology. J Dent Biomech. 2012;3:1758736012456543. doi: 10.1177/1758736012456543. Epub 2012 Aug 16. PMID: 22924065; PMCID: PMC3425398.

39. Moraschini V, de Almeida DCF, Calasans-Maia MD, Kischinhevsky ICC, Louro RS, Granjeiro JM. Immunological response of allogeneic bone grafting: A systematic review of prospective studies. J Oral Pathol Med. 2020 May;49(5):395-403. doi: 10.1111/jop.12998. Epub 2020 Feb 7. PMID: 31985847.

40. Rodriguez AE, Nowzari H. The long-term risks and complications of bovine-derived xenografts: A case series. J Indian Soc Periodontol. 2019 Sep-Oct;23(5):487-492. doi: 10.4103/jisp.jisp_656_18. PMID: 31543624; PMCID: PMC6737859.

41. Roca-Millan E, Jané-Salas E, Marí-Roig A, Jiménez-Guerra Á, Ortiz-García I, Velasco-Ortega E, López-López J, Monsalve-Guil L. The Application of Beta-Tricalcium Phosphate in Implant Dentistry: A Systematic Evaluation of Clinical Studies. Materials (Basel). 2022 Jan 16;15(2):655. doi: 10.3390/ma 15020655. PMID: 35057372; PMCID: PMC8778546.

42. Barone, Andrew W.; Andreana, Sebastiano; Dziak, Rosemary. Current Use of Calcium Sulfate Bone Grafts. Medical Research Archives, [S.l.], v. 8, n. 11, dec. 2020. ISSN 2375-1924.

43. Cheah CW, Al-Namnam NM, Lau MN, Lim GS, Raman R, Fairbairn P, Ngeow WC. Synthetic Material for Bone, Periodontal, and Dental Tissue Regeneration: Where Are We Now, and Where Are We Heading Next? Materials (Basel). 2021 Oct 15;14(20):6123. doi: 10.3390/ma14206123. PMID: 34683712; PMCID: PMC8537464.

44. Lin HK, Pan YH, Salamanca E, Lin YT, Chang WJ. Prevention of Bone Resorption by HA/β-TCP + Collagen Composite after Tooth Extraction: A Case Series. Int J Environ Res Public Health. 2019 Nov 21;16(23):4616. doi: 10.3390/ijerph16234616. PMID: 31766327; PMCID: PMC6926561.

45. Horowitz RA, Mazor Z, Miller RJ, Krauser J, Prasad HS, Rohrer MD. Clinical evaluation alveolar ridge preservation with a beta-tricalcium phosphate socket graft. Compend Contin Educ Dent. 2009 Nov-Dec;30(9):588-90, 592, 594 passim; quiz 604, 606. PMID: 19998726.