Evaluation of Erich Arch Bars, IMF Screws and Hybrid Arch Bars in the Management of Mandibular Fractures: A Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 3
- 主要终点
- Time taken to apply fixation device
研究概览
简要总结
Treatment options of mandibular fractures can be accomplished with either closed treatment or open reduction internal fixation (ORIF). Maxillomandibular fixation (MMF) refers to any method used to secure the maxilla and mandible in proper dental occlusion. MMF is a standard component of mandibular fracture management essential for closed treatment and commonly used du ring ORIF. Its three main principles are to establish occlusion, provide stability, and immobilize the jaws.
详细描述
An abundance of modalities used for establishing MMF have been reported in the literature. Traditionally, Ivy eyelets wiring, Risdon wiring, metal splints, acrylic splints and Erich arch bars are used. Progressively, new techniques such as Intermaxillary Fixation (IMF) screws, wiring around single tooth with tight contacts, use of 2 miniplates, use of zip ties, use of bondable buttons and 2 looped wires have been developed to expedite securement of MMF.
The conventional MMF procedure uses arch bars of malleable strips of steel-bearing hooks, also known as Erich arch bars (EABs), allowing hands-free achievement and maintenance of excellent intraoperative occlusion with reproducibility.
However, the placement of Erich arch bars (EABs) fixated to the dentition with circumdental stainless-steel wires has been the standard practice for MMF for or during the repair of mandibular fractures for many decades.
Most of these techniques are limited in the setting of poor dentition or in patients who are partially edentulous, in addition of being time consuming, and are associated with risks of mucosal, dental, and needlestick injuries.
A hybrid arch bar (HAB) for MMF has been introduced to overcome some disadvantages of conventional arch bars. The HAB differs from the EAB because they are secured directly to the alveolar bone with screws rather than using teeth for anchorage.
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 with mandibular fracture indicated for MMF. (Favorable fractures, minimally displaced).
- •Patients with an age range from 18:50 years old.
- •Patients free from any systemic diseases.
排除标准
- •Patients that are not willing to participate in this clinical trial.
- •Edentulous patients or those with inadequate dentition for occlusal guidance
- •Pathological fractures.
- •Patients with absolute or relative contraindications to MMF (e.g. pregnancy, mental disorders and systemic diseases).
研究组 & 干预措施
HAB Group
干预措施: Hybrid Arch Bars (Device)
EAB Group
干预措施: Erich Arch Bars (Device)
IMF Screws Group
干预措施: IMF Screws (Device)
结局指标
主要结局
Time taken to apply fixation device
时间窗: Four to six weeks
Occlusal Stability/instability: clinically assessed (Chairside)
时间窗: Four to six weeks
Stability categorizations: 1. Stable: center of force hasn't shifted showing clinically balanced forces across the dental arch 2. Unstable: center of force has shifted showing clinically imbalanced forces across the dental arch
次要结局
- Wire retightening frequency(Four to six weeks)
- Complications (e.g., iatrogenic injuries, displacement, splaying)(Four to six weeks)
- Gloves perforation incidence(Four to six weeks)
- Patient acceptance and hardware tolerability (evaluated using Visual Analog Scale (VAS)(Four to six weeks)
- Soft tissue evaluation Gingival Index developed by Loe and Silness. The Gingival Index scores will be: 0 - Normal 1- Mild inflammation 2- Moderate inflammation 3 - Severe inflammation(Four to six weeks)
- Patient acceptance and hardware tolerability (evaluated using Visual Analog Scale (VAS) VAS Scores: -Good: Minimal discomfort/pain -Fair: Moderate discomfort/pain -Poor: Significant discomfort/pain(Four to six weeks)
- Fracture union/non-union: assesed radiographically using cone beam computed tomography CBCT and Panoramic X-ray OPG.(Four to six weeks)
研究者
Zead Ahmad Alkurdi
MSc Candidate at oral and maxillofacial surgery department, faculty of dentistry, Mansoura University,
Mansoura University