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Randomized clinical trial on the efficacy of Escherichia coli-derived rhBMP-2 with ${\beta}$-TCP/HA in extraction socket

  • Huh, Jung-Bo (Department of Prosthodontics, School of Dentistry, Pusan National University) ;
  • Lee, Hyo-Jung (Department of Periodontology, Section of Dentistry, Seoul National University Bundang Hospital) ;
  • Jang, Ji-Woong (Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry) ;
  • Kim, Myung-Jin (Department of Periodontology, In-je University Haeundae Paik Hospital) ;
  • Yun, Pil-Young (Department of Oral and Maxillofacial Surgery, Section of Dentistry, Seoul National University Bundang Hospital) ;
  • Kim, Su-Hong (Research & Development Institute, Cowellmedi Co.) ;
  • Choi, Kyung-Hee (Research & Development Institute, Cowellmedi Co.) ;
  • Kim, Young-Kyun (Department of Oral and Maxillofacial Surgery, Section of Dentistry, Seoul National University Bundang Hospital) ;
  • Cho, Kyoo-Sung (Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry) ;
  • Shin, Sang-Wan (Department of Prosthodontics, Institute for Clinical Dental Research, Korea University Guro Hospital, Korea University)
  • Received : 2011.08.05
  • Accepted : 2011.09.01
  • Published : 2011.09.30

Abstract

PURPOSE. This randomized clinical trial was conducted to assess the safety and effectiveness of the ErhBMP-2 in alveolar bone regeneration as well as preservation of the ${\beta}$-TCP bone graft material that contains ErhBMP-2. MATERIALS AND METHODS. This study involved 72 patients at the 3 study centers. The patients, who were divided into 2 groups: the experiment group who had ErhBMP-2 coated TCP/HA and the control group who had TCP/HA graft material alone transplanted immediately after tooth extraction. CT was taken before and 3 months after the transplantation and healing status was compared between the two groups. The efficacy endpoints that were used to measure the degree of bone induction included alveolar bone height and 3 measurements of bone width. The paired t test was used to determine the significance of the changes (P<.05). RESULTS. Changes in alveolar bone height were $-1.087{\pm}1.413$ mm in the control group and $-.059{\pm}0.960$ mm in the experimental group (P<.01). At 25% extraction socket length [ESL], the changes were $0.006{\pm}1.149$ mm in the control group and $1.279{\pm}1.387$ mm in the experimental group. At 50% ESL, the changes were $0.542{\pm}1.157$ mm and $1.239{\pm}1.249$ mm, respectively (P<.01 for 25% ESL, and P<.05 for 50% ESL). During the experiment, no adverse reactions to the graft material were observed. CONCLUSION. ErhBMP-2 coated ${\beta}$-TCP/HA were found to be more effective in preserving alveolar bone than conventional ${\beta}$-TCP/HA alloplastic bone graft materials.

Keywords

References

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