Trapezoidal Condylar Plate (TCP) Versus Two Miniplates in Treatment of Subcondylar Fracture
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- comparison in pain between the two groups
研究概览
简要总结
Background: Condylar fracture is a common mandibular fracture which accounts for 25-40%. Nowadays the preference started to change towards open reduction because of the late complications that might happen in case of closed treatment.
A Transmasseteric Anteroparotid (TMAP) approach for open reduction and internal fixation of condylar fractures overcomes the problems of difficult access and facial nerve injury risk of other conventional approaches.
Different plating options are available for internal fixation of the condyle and subcondylar region. Trapezoidal Condylar Plates (TCP) specifically developed for the osteosynthesis of low and high subcondylar fracture. These plates were designed to closely follow the tensile strain lines along the rim of the sigmoid notch anteriorly combined with a posterior arm to parallel the condylar axis free of harmful bending strains.
详细描述
Background: Condylar fracture is a common mandibular fracture which accounts for 25-40%. It is the most controversial fractures regarding diagnosis and management.
For several years, closed reduction has been preferred over open reduction to avoid surgical complications. Nowadays the preference started to change towards open reduction because of the late complications that might happen in case of closed treatment.
A Transmasseteric Anteroparotid (TMAP) approach for open reduction and internal fixation of condylar fractures overcomes the problems of difficult access and facial nerve injury risk of other conventional approaches.
Different plating options are available for internal fixation of the condyle and subcondylar region. Trapezoidal Condylar Plates (TCP) specifically developed for the osteosynthesis of low and high subcondylar fracture. These plates were designed to closely follow the tensile strain lines along the rim of the sigmoid notch anteriorly combined with a posterior arm to parallel the condylar axis free of harmful bending strains.
Aim: Our aim in this study is to assess the use of TCP in the subcondylar fracture in comparison to the use of conventional two miniplates method.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1- Medically fit patients free from relevant conditions that contraindicate surgery.
- •2- Patients with age ranged from 20-40 years old. 3- Patients suffering from displaced extracapsular mandibular subcondylar fracture indicated for open reduction including Difficulty of obtaining adequate occlusion by closed method, Radiological signs of the following
- •Deviation of the fragment from the axis of the ascending ramus in medial or lateral direction more than 10°.(22)
- •Shortening of the ascending ramus ≥ 2 mm measured from the roof of glenoid fossa to the inferior border of the ascending ramus of the mandible.(22)
- •Dislocation of the condyle from the glenoid fossa.(48)
排除标准
- •Patients who were not able to follow the information given or to make a decision themselves due to mental or other problems.
- •Any absolute contraindication for surgery.
- •Patient with undisplaced condylar fractures that doesn't cause malocclusion or loss of facial heightening and can be treated conservatively.
结局指标
主要结局
comparison in pain between the two groups
时间窗: preopertive, 1 week, 1month
the change in pain value with Visual analogue Scale With a visual analogue scale (VAS) with values from 0 (no pain) to 10 (strongest pain or discomfort)
bone density change comparison between the two groups
时间窗: 1 day postoperative, 1month and 3months
assessment with CT in Hounsfield value measurements.
comparison of functional mandibular movement between the two groups
时间窗: preopertive, 1 week, 1month , 3 months , 6months
the change mandibular movement in mm
comparison of helikmo index between the two groups
时间窗: preopertive, 1 week, 1month , 3 months , 6months
the change in helikmo index score
comparison in ramus height shortening between the two groups
时间窗: 1 day, 3 months, 6 months.
radiographically: assess the adequacy of reduction by th change in ramus height in mm
comparison of occlusion between the two groups
时间窗: preopertive, 1 week, 1month , 3 months , 6months
the change in occlusion intercuspation assessed visually by the surgeon and by asking the patient
comparison in condylar angulation between the two groups
时间窗: 1 day, 3 months, 6 months.
radiographically: assess the adequacy of reduction by measuring the change in condylar angulation
次要结局
- Transmasseteric Anteroparotid surgical approach(intraopertive)
- the stress on plates by using finite element analysis(immediate postopertive)
- the displacement (micromotion)(immediate postoperative)
研究者
mona oraby
Assistant lecturer, oral and maxillofacial surgery department
Alexandria University