Evaluation of the Osteoinductivity of Atorvastatin Combined With β-TCP in the Treatment of Bone Defects After Radicular Jaw Cyst Enucleation Using CBCT-based Volumetric Analysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The Rate of shrinkage of the residual bone defect
研究概览
简要总结
This case series study aims to evaluate the local effects of Atorvastatin (which belongs to the family of lipid-lowering drugs, known as statins) combined with β-TCP (which is a synthetic osteoconductive bone graft), on the volume of the residual bone defects and on hastening the bone regeneration after radicular jaw cyst enucleation using CBCT-based volumetric analysis to calculate the shrinkage rate of these defects.
详细描述
Statement of the problem:
According to the literature, the residual bone defects after medium-large-sized jaw cyst enucleation pose the risk for infection, insufficient healing, and pathological fracture. the gold standard of bone grafting materials remains the autologous bone graft, yet it is accompanied by risks including second surgery, the morbidity of the donor site, excessive bleeding, etc.
Therefore, there is a constant search for alternative bone grafting materials, this is where the addition of atorvastatin to an osteoconductive synthetic bone grafting material (β-TCP) comes in. β-TCP takes anywhere from 6 to 18 months for complete resorption and replacement by bone, according to the literature.
The addition of an osteoinductive material to an osteoconductive grafting material like β-TCP holds two premises; increasing the resorption of the β-TCP particles at the expense of bone deposition, and therefore leads to hastening the bone generation of the residual bone defects.
Rationale:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female patients
- •Patients 18 to 40 years old
- •Radicular cyst with a maximum diameter from 1.5 to 4.0 cm;
- •Focal teeth were preserved with root canal treatment;
- •No previous surgical treatment of the cyst site;
- •No evidence of acute inflammation;
- •In good physical status and oral health;
- •Regular attendance at control visits
排除标准
- •Patients < 17 years old
- •Radicular cyst with a maximum diameter < 1.5 cm.
- •Pregnancy or lactation
- •Aggregate systemic pathologies such as diabetes, thyroid disorders, and bone metabolism diseases, among others;
- •Patients taking calcium, bisphosphonates, glucocorticoids, or other drugs that can interfere with the metabolism of bone;
- •Patients with uncontrolled periodontal conditions, endodontic conditions, and other oral disorders;
- •Heavy smokers (10 cigarettes/day or more)
结局指标
主要结局
The Rate of shrinkage of the residual bone defect
时间窗: 3 moths post-operatively and 6 months post-operatively
the shrinkage of the residual bone defects after bone grafting, measured from the following formula: pre-operative cyst volume - 3/6 months post-operative defect volume/pre-operative cyst volume x 100%. it will be measured radiographically using CBCT through manual segmentation
次要结局
- Incidence of Inflammation at the grafted site(1 week post-operatively, 3 months post-operatively and 6 months post-operatively)
研究者
Yara Gamal Mohamed Mahmoud
post-graduate master student
Cairo University