Johnson Alan W
Altru Health System, Grand Forks, North Dakota; and Department of Surgery, University of North Dakota School of Medicine & Health Sciences Grand Forks North Dakota.
Laryngoscope Investig Otolaryngol. 2017 Apr 12;2(4):178-183. doi: 10.1002/lio2.77. eCollection 2017 Aug.
For decades, Erich arch bars have been a standard in establishing maxillo-mandibular fixation (MMF). While reliable, the approach risks sharps injury, consumes operating room time, and inflicts gingival trauma. Newer technologies including screw-based techniques and "hybrid" techniques have improved MMF by reducing sharps injuries and operating room time, but risk injury to tooth roots, nerves, and gingiva. This study aims to establish the application, strengths, and limitations of dental occlusion ties as a novel alternative in maxillo-mandibular fixation.
Prospective, non-blinded, human feasibility clinical trial.
An iterative prototyping process was used to invent dental occlusion ties (brand name: Minne Ties). Development included 3D printing, cadaver prototype testing, human apical embrasure measurement, and ultimately non-significant risk human clinical trial testing. In the IRB-approved feasibility clinical trial, the devices were applied to mandible and maxilla fracture candidates with fractures amenable to intra-operative MMF with open reduction with internal fixation. The ties were removed prior to extubation. Pre-teens, comminuted fracture patients, and patients requiring post-operative MMF were excluded.
Manufactured, sterile prototypes secured MMF successfully in management of unilateral and bilateral mandible and maxilla fractures. All patients reported correction of pre-operative malocclusion. Application times were typically 12-15 minutes for a single surgeon to achieve MMF. Patients incurred negligible gingival trauma from the technology as the ties require no tissue penetration for application.
Dental occlusion ties offer a non-invasive solution featuring operating room efficiency, minimized sharps risk, and less bony and soft tissue trauma than current commercialized solutions.
Therapeutic, IV.
数十年来, Erich 牙弓夹板一直是建立颌间固定(MMF)的标准方法。虽然可靠,但该方法存在锐器伤风险,会消耗手术室时间,并造成牙龈创伤。包括基于螺钉的技术和“混合”技术在内的新技术通过减少锐器伤和手术室时间改进了颌间固定,但存在损伤牙根、神经和牙龈的风险。本研究旨在确定牙合扎带作为颌间固定新替代方法的应用、优点和局限性。
前瞻性、非盲法人体可行性临床试验。
采用迭代原型制作过程发明牙合扎带(商品名:Minne Ties)。开发过程包括3D打印、尸体原型测试、人体根尖间隙测量,最终进行无显著风险的人体临床试验测试。在经机构审查委员会批准的可行性临床试验中,将这些装置应用于下颌骨和上颌骨骨折患者,这些骨折适合在切开复位内固定术中进行术中颌间固定。在拔管前移除扎带。排除青少年前期患者、粉碎性骨折患者和需要术后颌间固定的患者。
制造的无菌原型成功地在单侧和双侧下颌骨及上颌骨骨折的治疗中实现了颌间固定。所有患者均报告术前错牙合得到矫正。对于单一外科医生而言,实现颌间固定的应用时间通常为12 - 15分钟。由于扎带在应用时无需穿透组织,患者因该技术导致的牙龈创伤可忽略不计。
牙合扎带提供了一种非侵入性解决方案,具有手术室效率高、锐器风险最小化以及与当前商业化解决方案相比更少的骨和软组织创伤的特点。
治疗性,四级。