Patient Specific Three-Dimensional Titanium Plates Versus Conventional Miniplates for Treatment of Mandibular Body Fractures. (Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Patient Satisfaction measured with visual analogue scale (0-10)
研究概览
简要总结
The aim of the current study is to evaluate and assess the clinical stability and efficacy of patient specific computer guided titanium plates versus the conventional titanium mini plates regarding accurate reduction and fixation of mandibular body fractures, reducing the operating time, achieving precise bone alignment and reducing the plate palpability.
详细描述
The study will be conducted on two groups:
Intervention group: patient specific three-dimensional titanium plates CBCT or CT scan will be performed for the patient, the dicom files will be imported into a surgical planning software , plates will then be designed virtually and sent for three-dimensional (3D) printing.
Control group: Conventional miniplates:
In this group two miniplates of titanium Mini-System 2.0 mm will be used. The plate has profile height 1.0 mm whereas the screw length varies according to the site of the plate. According to Champy osteosynthesis lines for fixation of the posterior mandibular fracture ,the first plate will be placed at the inferior border from the buccal side, using bicortical screws engaging the buccal and lingual cortices to achieve rigid fixation, while the second plate will be placed at about 5mm superior to the inferior plate in the subapical region, using monocortical screws engaging only the buccal cortex to avoid injuring the teeth roots.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with unilateral mandibular body fractures, not associated with other mandibular and maxillofacial fractures
排除标准
- •Patients with bilateral mandibular fractures
- •Patients with other mandibular or maxillofacial fractures
- •Comminuted fractures
- •Medical problem that may interfere with the procedure such as bleeding disorder and pregnancy.
结局指标
主要结局
Patient Satisfaction measured with visual analogue scale (0-10)
时间窗: Measured immediately after the surgery
patient satisfaction is defined as patient-reported outcome measure while the structures and processes of care can be measured by patient-reported experiences (30). Measured on a visual analogue scale (VAS) (29) of 0-10 ,with zero being unsatisfied and 10 being satisfied. Patient Satisfaction is assessed regarding prescence of pain, occlusal discrepencies and overall patient satisfaction.
次要结局
- Plate palpability(0 and 3 months)
- Fracture gap distance(0 and 3 months)
- Occlusal bite force(0 and 3 months)
- Operating time(time of the surgery)
研究者
Dina Adel
Master degree student
Cairo University