3D Vs Standard Miniplate in Fixation of the MAFs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- postoperative complications
研究概览
简要总结
- The aim of this study is to compare the standard and 3D miniplates fixation in mandibular angle fractures regarding to wound dehiscence, infection, nonunion, pain, hypoesthesia, and malocclusion. and to analyze advantages and disadvantages of one method over the other.
- Radiographic follow-up (in the form of posteroanterior and panoramic radiographs) will used to evaluate the patients immediately and 2 and 4 months postoperatively. Patients returned 7 days after surgery for clinical evaluation . The patients will be examined radiographically for accuracy of the reduction, screw positioning, adverse reactions in the vicinity of screw placement, and bone healing. the complications encountered will be recorded and treated. The clinical evaluations will be performed by 1 surgeon at each institution.
- The patients will also evaluated clinically for infection, nonunion, pain, hypoesthesia, and malocclusion. Malocclusion will assessed based on patient complaints. Criteria for infection will based on either of the following conditions: 1) purulent discharge from an incision and 2) serosanguineous drainage and a wound culture positive for a known pathogen. All the patients will evaluated postoperatively by a single assessor.
- Statically analysis :
Student's t test will be used to compare 3D and Champy's miniplate fixation. A value of P ≤ 0.05 will be considered statistically significant.
详细描述
- This study will include 20 dentate patients with mandibular angle fracture whom presented for treatment at Department Of Oral and Maxillofacial Surgery, Faculty Of Oral And Dental Medicine, Cairo University.
- The patients after inclusion will be randomly divided into either Group A or Group B. Group A consist of 10 patients underwent open reduction with internal fixation of the angle mandibular fracture with 3D titanium miniplates whereas Group B consist of 10 patients underwent open reduction with internal fixation of the mandibular angle fracture with standard miniplate using a single miniplate technique of Champy's principle of osteosynthesis.
- Inclusion criteria: 1) Age group between 15-40 years. 2) patients with non-infected and non-comminuted mandibular angle fractures 3) surgical treatment provided within 7 days of injury via open reduction and internal fixation (ORIF) by an extra oral approach 4) no use of postsurgical maxillomandibular fixation (MMF) postoperatively 5) a 1-week duration of postsurgical oral antibiotic therapy.
- Exclusion criteria : 1) the fracture was infected at the time of treatment, 2) medical conditions that could possibly have interfered with healing (diabetes, chemotherapy, etc.) or prevented general anesthesia.
- Preoperative Evaluation
Careful extra and intraoral clinical examinations will be perform on all patients. The presence of lacerations, swelling, ecchymosis, occlusal disturbances, or broken, avulsed, or missing teeth will noted, and the mandibular movements, maximal interincisal opening, and nerve function will be recorded. Palpation of the mandible for areas of tenderness, segment mobility, bony crepitus, and tooth mobility will be also perform . Radiographic images (panoramic and posteroanterior) will be taken to evaluate the fracture. Immediately preoperatively, each patient will be given a standard dose of 1.5 g of Unasyn* and 8 mg of Epidron** intravenously.
-Surgical Technique:
After placement of arch bars, the fracture line will be exposed through extraoral a submandibular (Risdon) incision. Only the amount of soft tissue stripping necessary to visualize, reduce, and stabilize the fracture will be performed. Mobile teeth or teeth with apices that will be exposed in the fracture will be removed.
All a fracture site will be identified, reduced, and after obtaining satisfactory occlusion, temporary maxillomandibular fixation will be placed using either Erich's arch bar or Ivy loop eyelet wiring.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults dentate patients (>17 years old) with displaced an angle mandibular fracture
- •non infected non comminuted angle mandibular fracture
排除标准
- •infected angle mandibular fracture
- •atrophied mandibular fracture
- •angle fracture with subcondylar fracture
- •patients under 17 year
- •gun shout injury associated fracture
结局指标
主要结局
postoperative complications
时间窗: 6 monuths
1. Wound dehiscence (binary outcome) by Clinical examination 2. mal /un union (binary outcome) by Clinical examination 3. Evaluation of Occlusion (binary outcome) (Only after 3 months of fracture treatment) by using the treatment scoring system35 Surgeon's evaluation * 5 points: occlusion altered bilaterally. Reoperation required. * 3 points: occlusion altered on one side: Reoperation required * 1 point: occlusion altered on one side. The other side has to be adjusted. * 3 points: occlusion adequate on both sides but not the same as before injury. * 5 points: occlusion the same as before injury.
次要结局
- Radiographic follow-up(6 months)
研究者
ESSAM ALMORAISSI
lecturer in Faculty of Dentistry,Dhamar University,Yemen
Cairo University