Evaluation of Esthetic Satisfaction and Bone Augmentation Quality Using Purabone Added to β-tricalcium Phosphate Versus β-tricalcium Phosphate Alone in Secondry Alveolar Cleft Grafting . Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Esthetic satisfaction
研究概览
简要总结
P-patients with unilateral alveolar clefts I-purabone with -β-tricalcium phosphate graft C-β-tricalcium phosphate graft alone O-clinical out come Outcome name Measurement device Measurement unit Esthetic satisfaction (Primary outcome) Numerical rating scale(NRS) Number 0-10
Radiographic outcome:
Outcome name Measurment Device Measurment unite Bone volume
(Secondary out come) (CBCT)machine Cranex 3D Sordex Cubic millimeter Bone Density
(Secondary Outcome) (CBCT)machine Cranex 3D Sordex Hounsfield Unite Research Question Would purabone addition to β-tricalcium phosphate be more effective and esthetically satisfying than tricalcium phosphate alone in alveolar cleft 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with unilateral alveolar cleft indicated for bone grafting.
- •Patients age range between 8-12years.
排除标准
- •Patients with any systemic diseases that can affect normal bone and/or wound healing.
- •Patients with bilateral alveolar clefts.
研究组 & 干预措施
puerarin and β- tricalcium phosphate
purabone (puerarin) is an osteoinductive bone grafts used to augment bone healing.
β- tricalcium phosphate is an osteoconductive bone graft used to augment bone healing
干预措施: Puerarin (Drug)
puerarin and β- tricalcium phosphate
purabone (puerarin) is an osteoinductive bone grafts used to augment bone healing.
β- tricalcium phosphate is an osteoconductive bone graft used to augment bone healing
干预措施: β- tricalcium phosphate (Drug)
β- tricalcium phosphate alone
β- tricalcium phosphate is an osteoconductive bone graft used to augment bone healing
干预措施: β- tricalcium phosphate alone (Drug)
结局指标
主要结局
Esthetic satisfaction
时间窗: 6 months
outcome measured by numerical scale from 1-10
次要结局
- bone density(6 months)
- bone volume(6 months)
研究者
Mohamad Hamed Maklad
principal investigator
Cairo University