Validity of PEEK PSI Containing Autogenous Bone Graft for Maxillary Reconstruction Following Lesion Enucleation
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
- 否
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
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
Mohammed Zain
internal resident at oral and maxillofacial department
Cairo University
