Evaluation of the Efficacy of Custom-Made Inter-flex Three-Dimensional Plate in Treatment of Mandibular Fracture A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Radiographic evaluation
研究概览
简要总结
The goal of this clinical trial is to learn if The use of a 3D-designed Inter-flex plate will achieve safe and desirable anatomical & functional restoration with reduced operative time in mandibular fracture,
- Improvement of occlusal and inter-cuspal relation in addition to stabilized intra-fragmentary mobility,
- Offer greatest resistance to displacement
- shows most favorable biomechanical behavior
详细描述
Mandibular fractures most commonly accompany facial trauma, with nearly half of the patients requiring surgical repair. The treatment of fractures prioritizes the restoration of functionality through The realignment of fractured segments. Conventional methods, such as titanium plates, have been employed for this purpose; however, certain limitations have been observed, such as there is a chance of potential infection and mal-union in mandibular fracture site. Leading to the development of patient specific plates. Furthermore, recent advancements in digital technology in Dentistry enable creation of virtual models and simulations of surgical Procedures. Aim: Is to evaluate the effect of custom-made Inter-flex three dimensional plate vs conventional ready-made Titanium plates in Management of Mandibular Fracture Methodology: This study will be conducted on 20 sites with mandibular fracture in patients. The sites of fracture will be divided into two groups (Group I and Group II) randomly and equally via www.randomizer.org Group I: site with mandibular fracture will be treated with custom made Inter-flex three dimensional plate in site of mandibular fracture, Group II: site with mandibular fracture will be treated with a ready-made Titanium plates in site of mandibular fracture. The postoperative clinical evaluation included presence of infection, stability of the mandibular lower border, state of occlusion, maximal mouth opening. Postoperative radiographic examinations to evaluate the accuracy of reduction and bony union using postoperative c.t 24hour and 3 months by measuring the inter-fragmentary gap and the Intergonial distance.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are suffering from recent, uninfected, and minimally displaced or unfavorable mandibular fractures
- •Adult patients with no gender predilection that agreed to present for follow-up visits for minimum postoperative period of immediate,3 months,6 months.
- •A fracture that demands open reduction and internal fixation
- •Patients under ASA-1 category
排除标准
- •Comminuted, infected mandibular fracture.
- •Pediatric patients below 4 years old and geriatric patients with completely edentulous mouth.
- •Patient with osteoporosis
- •Medical compromised patient (Poorly controlled DM or HTN, COPD, morbid obesity (BMI ≥40), Recent (<3 months) MI, ongoing cardiac ischemia or severe valve dysfunction, severe reduction of ejection fraction, shock, sepsis, undergoing regularly scheduled dialysis, history (>3 months)
- •Fractures in completely edentulous patients
结局指标
主要结局
Radiographic evaluation
时间窗: 24 hour after surgery and after 3 months
Each patient will be radiographically assessed immediately post- operatively with the following machine specifications (model name: GE optima CT 520, software: GE health care volume viewer, power: AC 3-50 Hz, voltage: 75kva), after 24 hours, and after 3 months with CT scan to observe * Hardware failure (plate fracture or screw loosening), * The linear inter-fragmentary gap between the fractured segments * Intergonial distance was measured between the most inferior, lateral, and posterior points of the mandible bilaterally as determined on CT.
Mobility of fracture segments
时间窗: 24 hour after surgery
assessed through bimanual digital manipulation * Stable \>\> no movement of fragments. * Nonstable \>\> presence of movement.
State of occlusion
时间窗: after 24 hours and after 3 months of surgery
will be assessed by asking the patient to bite in maximum intercuspation at each follow-up (intact/deranged) also by recording molar relation as (satisfactory or deranged).
次要结局
未报告次要终点