Patient Specific 3D Printed Titanium Mesh Versus Computer Guided Calvarial Bone Graft for Orbital Floor Reconstruction: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Orbital volume Measuring
研究概览
简要总结
In this study, the hypothesis states that there is no significant difference between specified populations. In our case, the 3D printed patient-specific titanium mesh is thought to have the same effect and results in comparison with the computer-guided calvarial bone graft technique according to the related studies.
详细描述
Recruitment:
Patients' data will be enrolled in the database of the Outpatient clinics of the Department of Oral & Maxillofacial Surgery, Faculty of Dentistry, Cairo University
- If there is potential eligibility, the patient will be examined thoroughly as described before.
- Consecutive sampling is done through screening of patients. This will continue until the target population is achieved.
- Identifying and recruiting potential subjects is achieved through a patient database
Pre-operative data Collection:
All Patients will undergo CT scan and throughout medical history will be taken. Enophthalmos and orbital volume will be measured via CT data using DICOM viewers, the anterior orbital boundary is defined by a line joining the zygomatico-frontal process on each side. Cross-sectional area is measured using the region of interest (ROI) facility, after tracing the orbital outline The degree of enophthalmos is assessed by measuring the distance between the posterior surface of each lens and the anterior orbital boundary line.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with previous fresh maxillofacial trauma within 14 days affecting zygomatic bones and orbital walls.
- •Patients with medical history that did not hinder previous reconstruction of orbital floor defect.
- •Both genders males and females will be included.
排除标准
- •Patients with craniofacial anomalies or syndromes.
- •Subjected to irradiation in the head and neck area less than 6 months to -1 year before procedure
- •Pregnant or nursing females.
- •Psychiatric problems or unrealistic expectations.
- •Immunosuppressed or immunocompromised patients.
结局指标
主要结局
Orbital volume Measuring
时间窗: Immediately Post Operative
次要结局
未报告次要终点
研究者
Mohammed Ghassan Mohammed Shaalan
Master Student
Cairo University