Polycaprolactone resorbable mesh (PCL) versus Titanium mesh for the management of orbital floor fracture - A comparative study
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness of polycaprolactone Mesh and Titanium mesh in management of orbital floor fracture
研究概览
简要总结
Resorbable mesh has been in use for many years with advancements over the years. Polycaprolactone is a new material that has been introduced for the reconstruction purposes of orbital floor. However there have not been many studies in the literature regarding this material for its use in orbital floor reconstruction. Review of literature shows there have been very few studies comparing polycaprolactone mest to titanium mesh. Hence the purpose of this study is to compare the functional and structural outcomes of orbital floor reconstruction using polycaprolactone resorbable mesh against the titanium mesh
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Orbital floor fractures indicated for reconstruction Patients should be medically fit in accordance with ASA grade assessment (limited to ASA grade 1 and grade 2) Size of the defect should be limited between 6mm to 20mm.
排除标准
- •Patients with comminuted fractures in orbital region Any pathologies or infections in orbital region Fracture older than 2 weeks Patient with loss of vision following trauma Non compliant patients.
结局指标
主要结局
To evaluate the effectiveness of polycaprolactone Mesh and Titanium mesh in management of orbital floor fracture
时间窗: Post operatively 1 week 1 month and 3 months
To evaluate and compare polycaprolactone Mesh and Titanium mesh in the management of orbital floor fracture
时间窗: Post operatively 1 week 1 month and 3 months
次要结局
- Clinical assessment of ocular functions Enophthalmous, Extra occular muscle movement impairment and diplopia(Radiological assessment using CT/CBCT)
研究者
Vishesh Bhardwaj
AJ Institute of Dental Sciences