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临床试验/NCT01561534
NCT01561534Unknown不适用

Long-term Results of Mandibular/Maxillary Reconstruction With Vascularized Free Fibula Flap and Computer-guided Implant Surgery

University of Bari1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
5
试验地点
1
主要终点
change of peri-implant bone level from baseline at 12 and 24 months

研究概览

简要总结

The rehabilitation of patients affected by defects of the jaws after tumor resection is still very challenging. Resection can lead to significant facial deformity, impaired oral functions such as speech, swallowing, saliva retention, and concomitant psychological problems. Moreover, the loss of teeth and the alveolar and basal jawbone can lead to significant impairment of mastication. The reconstruction of such defects with autogenous bone grafts or revascularized free flaps has become a valuable means for the rehabilitation of these patients. Major benefits of such procedure include an usually low morbidity of the donor site and an extensive length of the bone graft. Moreover, vascularized grafts provide a good bulk of bone in which to place implants and a satisfactory contour. In fact, after reconstruction, local hard and soft tissue conditions often exclude the integration of conventional dentures because of the impairment of dental prosthetic retention by thin cutaneous tissue, the thickness of subcutaneous tissues, the absence of a perilingual and vestibular groove, and the fragility of soft tissues. In Literature it has been well established the high biologic value of vascularized fibula grafts regarding the potential of implant osseointegration, which seemed to be equal to regional mandibular or maxillary bone and eventually capable to provide sufficient stabilization of prosthesis.

It must be kept in mind that the final prosthetic success may be affected by some difficulties in this clinical scenario. These include the limited opening of the scar-contracted oral cavity, the huge amount of soft tissue covering the fibula, with little information about the profile of the underlying harvested bone, the need for limited bony exposure in a field that may well have been irradiated and they all may cause poor prosthetically-guided implant positioning and eventually disappointing results in dental rehabilitation, either functionally or esthetically. It can be postulated that these complications can be overcome, or at least reduced, by adopting the new methods of computed tomography (CT)-assisted implant surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • patients with free fibula flaps for maxillary and mandibular reconstruction needing full arch or quasi full arch rehabilitation

排除标准

  • radiation therapy
  • malignant tumor

结局指标

主要结局

change of peri-implant bone level from baseline at 12 and 24 months

时间窗: 12 months and 24 months

successful implants will be those with peri-implant bone resorption less than 1.5 mm in the first year of function and less than 0.2 mm in the subsequent years

次要结局

  • pain(12 months and 24 months)
  • peri-implant infection(12 months and 24 months)

研究者

发起方
University of Bari
申办方类型
Other
责任方
Principal Investigator
主要研究者

MICHELE DE BENEDITTIS

principal investigator

University of Bari

研究点 (1)

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