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
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