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Egg shell derived hydroxyapatite as bone graft material in maxillofacial skeleton – A randomized blind multi-center clinical trial.

Vivekanand Kattimani1*, Krishna Prasad L1*, Chakravarthi P1*, Anil Managutti2*, Hemal Katwala2*, Sampathkumar Ts3*, A Siddharthan4* and Girija E. K5*
  • 1 SIBAR Institute of dental sciences, Oral and Maxillofacial Surgery, India
  • 2 Narsinhbhai Patel Dental College & Hospital, Oral and Maxillofacial Surgery, India
  • 3 Indian Institute of Technology Madras, Medical Materials Laboratory, Department of Metallurgical and Materials Engineering, India
  • 4 Anna University, Department of Production Technology, India
  • 5 Periyar University, Salem 636 011, Tamil Nadu., Department of Physics, India

Background: The grafting of bone for enhancement of bone regeneration is known since long time.[1][2][3] In maxillofacial skeleton after cystic removal, bony defects and impacted tooth usually the grafting will be done to prevent complications and enhance the bone regeneration.[4][5] Various bone regenerative materials have been used with varying degree of success. [2][3]Because of advancement in the Biomaterial technology the regenerative science has changed its face.[2] Emerging technology made it possible to use egg shell waste as raw material to produce HA.[6][7] The HA prepared from egg shell waste as shown promising in vitro results.[8][9][10] The studies with EHA is emerging with promising results in very economical way.[11][12] So the study has been planned to assess efficacy of EHA in maxillofacial skeleton. 

Aim and Objectives: Aim of the study is to evaluate the effectiveness of Egg shell derived hydroxyapatite (EHA) as graft material in the enhancement of bone regeneration after removal of impacted third molar. The osseous fill was assessed using digital radiographs and clinical evaluation of gingival attachment measured.

Material and Methods: Twenty patients (ten patients in each center) enrolled for the pilot study. A split mouth randomized case control blind multicenter protocol followed to test efficacy of the EHA.  After surgical removal of bilateral impacted third molars using standard operating protocol, case site was grafted with indigenously prepared EHA and other left unfilled as control. The patients were followed up at 1st and 2nd week post operatively for signs or symptoms of infection or any other complications related to the procedure. Radiographic observations were done at 1st , 3rd and 6th month post surgically to assess the amount of osseous fill. The observers were blinded both for time duration of follow-up and surgical procedure.

Results: Wound healing was uneventful in all the patients. The clinical attachment level and bone formation in grafted sites were significantly higher than the control sites. Both centers showed similar bone formation.

Conclusion: This multicenter pilot study results showed promising results with EHA. The enhancement of bone formation was observed in comparison with control group.  EHA will emerge as economic, safe synthetic graft material for grafting in maxillofacial skeleton. The process of preparation of EHA is go green. The Egg shell waste is valuable raw material for EHA production in cost effective way with no disease transfer risks.  

References:
[1] Kromer H. Bone homografts in minor oral surgery. Proc R Soc Med 1962;55:607-14.
[2] Damien CJ, Parsons JR. Bone graft and bone graft substitutes: A review of current technology and applications. J Appl Biomater 1991;2:187-208.
[3] Habal MB, Reddi AH. Different forms of bone grafts. In:Habal MB, Reddi AH (Editor). Bone Grafts and Bone Substitutes. Philadelphia: Saunders, 1992. p. 6-8.
[4] Kattimani VS, Chakravarthi SP, Neelima Devi KN, Sridhar MS, Prasad LK. Comparative evaluation of bovine derived hydroxyapatite and synthetic hydroxyapatite graft in bone regeneration of human maxillary cystic defects: A clinico-radiological study. Indian J Dent Res 2014;25:594-601.
[5] Thorondson RR, Sexton SB. Grafting mandibular third molar extraction sites: A comparison of bioactive glass to a nongrafted site. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 Oct;94(4):413-9.
[6] http://ipindiaonline.gov.in/patentsearch/GrantedSearch/completeSpecification.aspx?ID=848/CHE/2006. ( Latest Accessed on 25 September 2015)
[7] G. Suresh Kumar, A. Thamizhavel, E.K. Girija. Microwave conversion of eggshells into flower-like hydroxyapatite nanostructure for biomedical applications. Materials Letters 2012;76:198–200.
[8] Park JW, Bae SR, Suh JY et.al. Evaluation of bone healing with eggshell-derived bone graft substitutes in rat calvaria: A pilot study. J Biomed Mater Res 2008;87A:203-14.
[9] S.H Kim, W Kim, J.H Cho, N.S Oh, M.H Lee, S.J Lee .Comparison of bone formation in rabbits using hydroxyapatite and β-tricalcium phosphate scaffolds fabricated from egg shells. Advanced Materials Research Vols 2008;47-50:999-1002.
[10] M. Baliga , P.Davies, L Dupoirieux. La poudre de coquille d’oeuf dans le comblement des cavites cystiques des maxillaires. Rev. Stomatol Chir Maxilofac 1998;99:86-88.
[11] Kattimani VS, Chakravarthi PS, Kanumuru NR, Subbarao VV, Sidharthan A, Kumar TS, Prasad LK. Eggshell derived hydroxyapatite as bone graft substitute in the healing of maxillary cystic bone defects: A preliminary report. J Int Oral Health 2014;6(3):15 9.
[12] Kattimani VS, Prasad LK, Chakravarthi PS, Kumar TS, Sidharthan A. Egg Shell Derived Hydroxyapatite – A New Era In Bone Regeneration.(J Craniofac Surg 2015 ahead of print)

Keywords: Bone Regeneration, Clinical Trial, Scaffold, Bone graft

Conference: 10th World Biomaterials Congress, Montréal, Canada, 17 May - 22 May, 2016.

Presentation Type: Poster

Topic: Regeneration inducing biomaterials

Citation: Kattimani V, L K, P C, Managutti A, Katwala H, Ts S, Siddharthan A and K GE (2016). Egg shell derived hydroxyapatite as bone graft material in maxillofacial skeleton – A randomized blind multi-center clinical trial.. Front. Bioeng. Biotechnol. Conference Abstract: 10th World Biomaterials Congress. doi: 10.3389/conf.FBIOE.2016.01.01893

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Received: 27 Mar 2016; Published Online: 30 Mar 2016.

* Correspondence:
Dr. Vivekanand Kattimani, SIBAR Institute of dental sciences, Oral and Maxillofacial Surgery, Guntur, India, Email1
Dr. Krishna Prasad L, SIBAR Institute of dental sciences, Oral and Maxillofacial Surgery, Guntur, India, Email2
Dr. Chakravarthi P, SIBAR Institute of dental sciences, Oral and Maxillofacial Surgery, Guntur, India, Email3
Dr. Anil Managutti, Narsinhbhai Patel Dental College & Hospital, Oral and Maxillofacial Surgery, Visnagar, North Gujarat, India, Email4
Dr. Hemal Katwala, Narsinhbhai Patel Dental College & Hospital, Oral and Maxillofacial Surgery, Visnagar, North Gujarat, India, Email5
Dr. Sampathkumar Ts, Indian Institute of Technology Madras, Medical Materials Laboratory, Department of Metallurgical and Materials Engineering, Chennai, India, Email6
Dr. A Siddharthan, Anna University, Department of Production Technology, Chennai, India, Email7
Dr. Girija E K, Periyar University, Salem 636 011, Tamil Nadu., Department of Physics, Salem, India, Email8