NCT03010345Unknown1 期
The Use of Self Inflating Tissue Expanders In The Treatment Of Alveolar Cleft
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Primary Outcome : Absence of nasal regurgitation. Binary (Yes/No)
研究概览
简要总结
patient receiving treatment using the osmed expander will have enough soft tissue coverage securing the bone graft which will be placed in a later stage to close the alveolar cleft.
详细描述
to prove that the group treated with osmed expanders will suffer no soft tissue dehiscence and will have a higher volume of soft tissue at the stage of bone grafting.
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
- Single (Investigator)
入排标准
- 年龄范围
- 7 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically free patients.
- •Patients suffering from alveolar cleft with anterior fistulas.
- •Age Between 7 and 13 Years
- •Both sexes.
- •Patients physically able to tolerate surgical and restorative procedures. Good oral hygiene.
- •Highly motivated patients.
排除标准
- •non motivated patients
结局指标
主要结局
Primary Outcome : Absence of nasal regurgitation. Binary (Yes/No)
时间窗: 21 days
次要结局
- Secondary Outcome : absence of soft tissue Dehiscence and preservation of bone graft volume , volume per cubic meter(Measured by cbct)(6 months)
研究者
Sherif Hany shams
Principal investigator
Cairo University
研究点 (1)
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