The Use of Self Inflating Tissue Expanders In The Treatment Of Alveolar Cleft
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
研究组 & 干预措施
Osmed self inflating tissue expanders
All patients will undergo a two-stage procedure ,second stage under General endotracheal anesthesia. The first stage will be placement of the expanders. The second stage will be 21 days later, with removal of the expanders, palatal revision, and closure of the oronasal fistula
干预措施: Osmed self inflating tissue expanders (Device)
Iliac bone graft
Placement of bone graft without the use of self inflating expanders
干预措施: Iliac bone graft (Other)
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