Evaluation of Titanium-prepared Platelet-rich Fibrin in Bone Regeneration in Lateral Window Maxillary Sinus Augmentation (Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in bone denisty
研究概览
简要总结
This trial aims to evaluate the effect of the sole use of T-PRF in bone formation process as applied in maxillary sinus floor elevation in comparison to traditional T-PRF/bone graft combination.
This study is clinical trial that will include 18 patients seeking implant placement in upper posterior maxilla compromised with maxillary sinus pneumatization. Patients will be assigned into control and test groups. All the patients will undergo sinus lifting procedure through which a combination of xenograft and T-PRF was used in the control group whereas; sole T-PRF will be applied in the test group.
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
- 18 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemically in a healthy condition.
- •Residual bone height is ≤5mm in the posterior maxilla as measured with CBCT.
- •Non-smokers.
- •Good oral hygiene as indicated by plaque and bleeding scores
排除标准
- •Medically compromised conditions will be excluded to avoid infections or any adverse reaction related to immunity suppression.
- •Acute maxillary sinusitis.
- •Patients administering any antibiotics or regular anti-inflammatory drugs.
结局指标
主要结局
Change in bone denisty
时间窗: up to 3 months
pre opertaive and post operative CBCT
Change in bone height
时间窗: up to 3 months
pre opertaive and post operative CBCT
Change in pain level
时间窗: up to 2 weeks
measuring level of pain using visual analog scale (VAS) 0-10, where 0 reading indicates no pain and 10 reading reflects the most severe pain.
Change in bone volume
时间窗: up to 3 months
pre opertaive and post operative CBCT
次要结局
未报告次要终点
研究者
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University