Assessment of Nanocrystalline Hydroxyapatite Versus Autogenous Bone Grafts : A Comparative Clinical Study in Alveolar Cleft Grafting
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Measuring of bone volume 6 months post-operative
研究概览
简要总结
This work aims to evaluate Nanocrystalline Hydroxyapatite versus Autogenous bone grafts in alveolar cleft grafting
详细描述
Alveolar cleft is the most common congenital bone defect. Since its introduction in 1972, alveolar bone grafting (ABG) has been widely accepted to correct alveolar bone defect in most cleft centres.The purpose of ABG is to restore the dental arch continuity, stabilize the maxilla, close the oronasal fistulae, facilitate subsequent orthodontic treatment, enhance nasal symmetry, establish better oral hygiene, limit growth disturbances, etc . Autologous bone grafting is the gold standard for treating alveolar clefts, with the iliac crest , bone being the most widely accepted donor site(Tan, Brogan et al. 1996.New bone graft substitutes have been devised in recent decades, such as demineralized bone matrix (DBM), bone morphogenetic proteins (BMPs), calcium phosphate (CP), calcium sulfate (CS), hydroxyapatite (HA), highly purified bovine xenograft, and more, but clinical evidence of their efficacy varies among clinical and experimental studies [4] With the advent of new biomaterials, which may include or consist of allogenic bone source such as collagen membranes, hydroxyapatite crystals, tricalcium phosphate powder that has been increased consideration for their placement in the repair of alveolar clefts as well as other dental applications
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age (7 - 12 years )
- •Non-syndromic CLA or CLP
- •More than 6 months of follow-up
排除标准
- •History of previous alveolar surgery
- •History of active infection or underlying disease such as hematologic disorders , neoplasm, and immune deficiency
- •Patients who had received primary or tertiary ABG
研究组 & 干预措施
Nano crystalline Hydroxyapatite (group B)
Nano crystalline Hydroxyapatite will be used to fill the alveolar defect
干预措施: Nanocrystalline Hydroxyapatite (Procedure)
autogenous iliac bone graft (group A)
autogenous iliac bone graft will be used to fill the alveolar defect
干预措施: secondary alveolar bone graft (Procedure)
autogenous iliac bone graft (group A)
autogenous iliac bone graft will be used to fill the alveolar defect
干预措施: harvesting of the autogenous bone graft (Procedure)
Nano crystalline Hydroxyapatite (group B)
Nano crystalline Hydroxyapatite will be used to fill the alveolar defect
干预措施: secondary alveolar bone graft (Procedure)
结局指标
主要结局
Measuring of bone volume 6 months post-operative
时间窗: 6 months
compare between outcome of nanocrystalline hydroxyapatite versus autogenous bone graft in alveolar bone grafting regarding the newly formed bone volume
次要结局
未报告次要终点
研究者
Abdullah Hashim Ahmed
MBBS
Assiut University
