Comparative Study Between Custom-made Polyether Ether Ketone and Titanium Mesh for Augmentation of Atrophic Posterior Mandible. Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Vertical amount of bone increased (length in millimeters). horizontal amount f bone increased after augmentation (width in millimeters).
研究概览
简要总结
Comparative study between custom-made polyether ether ketone and titanium mesh for augmentation of atrophic posterior mandible.
详细描述
Designing and manufacturing
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The CBCT images of the patient will be used to build a digital model using a 3D planning software (Mimics innovation suite). Based on this model, a machine will be used to mill a pressed and pre-sintered body of PEEK to the desired macroscopic shape.
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The size of the machined sheet is enlarged in order to compensate for the sintering shrinkage performed at 1450 C.
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After manufacturing, the sheet will be cleaned in an ultrasonic bath of 70% alcohol for 15 min, followed by a brief heating to 1200 C.
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It will be again cleaned in an ultrasonic bath for 3x15 min using 90% alcohol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with atrophic posterior mandible
- •No intraoral soft and hard tissue pathology
- •No systemic condition that contraindicate implant placement
排除标准
- •Untreated gingivitis, periodontitis
- •Insufficient oral hygiene
- •Previous radiation therapy the head and neck neoplasia, or bone augmentation to implant site.
- •Systemic disorders
- •Heavy smoking more than 20 cigarettes per day
- •Bone pathology
- •Psychiatric problems
- •Emotional instability
- •Unrealistic aesthetic demands
研究组 & 干预措施
Custom Made Poly Ether Ether Ketone Mesh
Applying Poly Ether Ether Ketone mesh with mix of autogenous bone graft and bone substitute in posterior atrophic mandible for augmentation
干预措施: under local anasthesia,Ridge Augmention of posterior atrophic mandible by using mix of autogenous bone graft and bone substitutes is used under PEEK mesh (Procedure)
Conventional Titanium mesh
Applying Titanium mesh with mix of autogenous bone graft and bone substitute in posterior atrophic mandible for augmentation
干预措施: under local anasthesia,Ridge Augmention of posterior atrophic mandible by using mix of autogenous bone graft and bone substitutes is used under PEEK mesh (Procedure)
结局指标
主要结局
Vertical amount of bone increased (length in millimeters). horizontal amount f bone increased after augmentation (width in millimeters).
时间窗: 6 months
Length (Vertical Augmentation) Width (horizontal augmentation) gained after augmentation of atrophic mandible in millimeters using cone beam computed tomography (measuring tool) measurment tools : with the aid of cone beam computed tomography
次要结局
- Rate of Soft Tissue Dehiscence(6 months)
研究者
Adham Zakaria
Master Degree Candidate.
Cairo University