跳至主要内容
临床试验/NCT03265795
NCT03265795Unknown不适用

Validity of PEEK PSI Containing Autogenous Bone Graft for Maxillary Reconstruction Following Lesion Enucleation

Cairo University0 个研究点目标入组 8 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
8
主要终点
oral health related quality of life

研究概览

简要总结

Surgical ablation of large maxillary cysts usually results in considerable hard and soft tissue deficits that ultimately affect the final esthetic and functional outcomes. Reconstruction of such defects; whether primarily or secondarily; offers much better long-term outcomes. However, primary bony reconstruction becomes potentially complicated in many cases of such large cysts encroaching or involving the maxillary sinus where a communication with the maxillary sinus lining may be unavoidable.

Reconstruction of such defects can be accomplished using either vascularized or; more commonly; non-vascularized autogenous bone grafts. Different bone substitutes remain to be another viable option. The simultaneous use of titanium meshes provides physical three-dimensional support for the bone graft contained within as well as the overlying soft tissues. However, the drawbacks of titanium meshes in such defects remain to be mainly the difficulty in adequately shaping the mesh and the lack of proper isolation of the mesh contents from the maxillary sinus cavity.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age of patients from 15 to 60 years old.
  • Patients with unilateral maxillary lesion encroaching maxillary sinus.
  • Dentulous or edentulous patients.
  • Patients should be free from any systemic disease that may affect normal healing of bone and predictable outcome.

排除标准

  • Patients with systemic diseases as history of radiation therapy or chemotherapy, hematological disorders, neuromotor disorders and autoimmune diseases (may affect normal healing).
  • Patients with bilateral maxillary lesions.
  • Children under 15 years old.

研究组 & 干预措施

PEEK patient specific implant

Experimental

this PEEK (poly ether ether ketone) Patient Specific Implant containing autogenous bone graft is used in reconstruction of the bone and the original volume of maxillary sinus accurately (in terms of clinical and radiographic parameters).

干预措施: Poly Ether Ether Ketone PSI (patient specific implant). (Device)

结局指标

主要结局

oral health related quality of life

时间窗: 4 months

OHIP-49 questionaire

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Zain

internal resident at oral and maxillofacial department

Cairo University

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