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

摘要

Background: The grafting of bone for enhancement of bone regeneration is known since long time. 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. Various bone regenerative materials have been used with varying degree of success.Because of advancement in the Biomaterial technology the regenerative science has changed its face. Emerging technology made it possible to use egg shell waste as raw material to produce HA. The HA prepared from egg shell waste as shown promising in vitro results. The studies with EHA is emerging with promising results in very economical way.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.