A Prospective Clinical Trial on the Mg Oxidized Clinical Implants

마그네슘 양극산화 임플란트의 성공률에 관한 전향적 임상연구

  • Im, So-Min (Department of Prosthodontics, College of Dentistry and Research Institute of Oral Science, Gangneung-Wonju National University) ;
  • Kim, Dae-Gon (Department of Prosthodontics, College of Dentistry and Research Institute of Oral Science, Gangneung-Wonju National University) ;
  • Park, Chan-Jin (Department of Prosthodontics, College of Dentistry and Research Institute of Oral Science, Gangneung-Wonju National University) ;
  • Cho, Lee-Ra (Department of Prosthodontics, College of Dentistry and Research Institute of Oral Science, Gangneung-Wonju National University) ;
  • Um, Heung-Sik (Department of Periodontology, College of Dentistry and Research Institute of Oral Science, Gangneung-Wonju National University) ;
  • Lee, Jae-Kwan (Department of Periodontology, College of Dentistry and Research Institute of Oral Science, Gangneung-Wonju National University)
  • 임소민 (강릉원주대학교 치과대학 보철학교실 및 구강과학연구소) ;
  • 김대곤 (강릉원주대학교 치과대학 보철학교실 및 구강과학연구소) ;
  • 박찬진 (강릉원주대학교 치과대학 보철학교실 및 구강과학연구소) ;
  • 조리라 (강릉원주대학교 치과대학 보철학교실 및 구강과학연구소) ;
  • 엄흥식 (강릉원주대학교 치과대학 치주과학 교실 및 구강과학연구소) ;
  • 이재관 (강릉원주대학교 치과대학 치주과학 교실 및 구강과학연구소)
  • Received : 2010.12.23
  • Accepted : 2011.03.25
  • Published : 2011.03.30

Abstract

In animal studies, Magnesium (Mg) - incorporated oxidized implants showed significant enhancement of the bone response. This prospective clinical trial was performed to investigate the success rate, implant stability and marginal bone loss of Mg oxidized clinical implant. The experimental protocol was approved by Institutional Review Board of the Gangneung-Wonju National University Dental Hospital. Fifty healthy patients had partial edentulism were included in this study. Mg oxidized clinical implants (Implant M, Shinhung, Korea) were installed and restored with conventional protocol. The patients were recalled at 1, 3, 6 months after functional loading. Implant stability quotient (ISQ) was measured and periapical radiographic images were obtained. Amount of marginal bone loss was calculated with calibrated images from periapical radiographs. Repeated measured analysis of variance and post hoc Tukey test were used to compare the mean ISQ and bone level. A total of 101 implants were analyzed. The mean ISQ values increased continuously with time lapse from 68.4 at fixture installation to 71.5 at 6 months after loading. Implant stability was correlated with gender, fixture diameter, bone quality and implant sites. The mean marginal bone loss during 6 months after loading was 0.26 mm. There was no failed implant and six-month success rate was 100%. Within the limitations of this study, the six-month success rate of Mg oxidized implant was satisfactory. The implant stability and marginal bone level were excellent. However, further longer clinical studies will be needed to confirm the success of Mg oxidized clinical implant.

마그네슘 양극산화 임플란트는 동물실험에서 우수한 골반응을 나타내었지만 이에 대한 임상 연구는 전무하다. 본 연구에서는 마그네슘 양극산화 임플란트의 단기간 성공률 및 안정성, 변연골 흡수량을 평가하고자 하였다. 강릉원주대학교 치과병원의 임상시험위원회의 승인을 거쳐 건강한 부분 무치악 환자에게 마그네슘 양극산화 임플란트를 식립한 후 일반적인 프로토콜에 따라 보철 치료를 시행하였다. 1차 수술, 2차 수술, 보철물 시적, 하중 후 1개월, 3개월, 6개월 평가를 시행하였으며, 매회 내원 시 임플란트 안정지수(Implant stability quotient, ISQ)를 측정하고 구내 치근단 방사선 사진에서 변연골 흡수량을 산출하였다. 반복측정이 있는 분산분석법을 이용하여 통계적 분석을 시행하였다. 총 50명에게 식립된 101개의 임플란트 중 골유착에 실패한 임플란트는 없었으며, 하중 후 6개월 성공률은 100%였다. 평균 ISQ는 시간이 경과함에 따라 증가하였으며 여성보다 남성에서, 상악보다 하악에서 높게 나타났다 (P<.05). 하중 6개월 후 골질이 양호할수록, 고정체 직경이 클수록 높은 ISQ 값을 보였다 (P<.05). 하중 후 6개월간 평균 변연골 흡수량은 0.26 mm로 관찰되었으며 하악보다 상악에서, 여성보다 남성에서 더 많은 흡수가 관찰되었다. 본 연구의 마그네슘 양극산화 임플란트의 6개월 성공률은 100%이며, 낮은 골질에서도 우수한 골유착이 관찰되었다. 안정성과 변연골 수준 또한 만족스러운 결과를 보였지만 더욱 장기적인 임상연구가 필요하다고 사료된다.

Keywords

References

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