The Restful Jaw Device: A New Way to Support and Protect the Jaw During Third Molar Extractions

项目摘要 牙科手术可能会导致下巴疼痛和不适，因为开口太长，太宽或太多 施加在患者下颌上的向下力。这些痛苦的症状可能是短暂的或成为慢性 导致颞下颌肌肉和关节紊乱（TMJD）。第三磨牙拔除（智齿） 与30%的术后TMJD发生率相关。当口腔外科医生提取下颌第三 磨牙，患者通常具有中度/深度镇静或全身麻醉，以及牙科助理 用他们的手支撑下颌，以抵抗与下颌骨相关的患者下颌上的向下力。 提取。但是，助手很难有效对抗力量的大小和方向 这种压力被放置在病人的下巴上，而镇静剂病人不能拉紧他们的肌肉来对抗这种压力。当前 口腔外科医生不对服用镇静剂的患者使用Restful Jaw（RJ 1）外部颌骨支撑装置，因为， 在医疗或镇静紧急情况下，如果不首先移动患者，则无法取出器械，并且 这就延误了治疗。我们已经完全重新设计了这个下颌支撑装置，并提出了一个 创新的新型Restful Jaw（RJ 2）器械，适用于中度/深度镇静或全身麻醉 麻醉，将在第三磨牙拔除过程中保护下颌，并解决重要问题。RJ2 该装置附接到牙科椅上的头枕的柱，因此其与患者的唯一接触是在 在她/他的下巴两侧。这种设计还允许将颌稳定在前部位置， 在中度/深度镇静或全身麻醉期间帮助维持气道通畅。最后，建议 RJ 2装置具有“快速释放”设计，在紧急情况下易于拆卸。在该项目的第一阶段， 将根据口腔颌面外科医生团队的意见开发、评估和修改RJ 2器械， 他们的助手和志愿者将在接受双侧手术的患者中评价初始器械原型 下颌第三磨牙拔除，中度/深度镇静或全身麻醉。外科医生和助手 我将报告如何容易和快速地放置和删除设备，以及它如何支持下巴， 允许他们在手术过程中根据需要移动下颌。II期将包括随机临床试验， 一项随机对照试验（RCT），涉及294名受试者和8名口腔外科医生，代表一个三级护理单位，一个大型工作人员模型 专业小组实践和私人实践。双侧下颌第三磨牙拔除的患者， 中度/深度镇静或全身麻醉将在以下两组之间随机分配： 由助手手动支撑钳口，或使用RJ 2器械支撑钳口的实验护理（EC）。期间 第二阶段，患者和外科医生将完成术前和术后问卷调查。RCT的目的 是检验与EC相关的术后TMJD疼痛的风险在统计学上小于 关于UC将在术后1个月、3个月和6个月随访时评估研究组比较。我们 预计RJ 2器械将保护患者的下颌，并降低TMJD疼痛的风险。

Project Summary Dental procedures can cause jaw pain and discomfort from opening too long, too wide or from having too much downward force placed on the patient's jaw. These painful symptoms can be short-lived or become chronic leading to temporomandibular muscle and joint disorders (TMJD). Third molar extractions (wisdom teeth) have been associated with a 30% incidence of post-operative TMJD. When oral surgeons extract mandibular 3rd molars, the patient typically has moderate/deep sedation or general anesthesia, and a dental assistant supports the jaw with their hands to oppose the downward force on the patient's jaw associated with the extractions. However, it is difficult for an assistant to effectively counter the magnitude and direction of force placed on the patient's jaw, and sedated patients cannot tense their muscles to counter this force. The current Restful Jaw (RJ1) external jaw support device is not used by oral surgeons with sedated patients because, during a medical or sedation emergency, the device cannot be removed without first moving the patient, and this delays treatment. We have completely redesigned this jaw support device and are proposing an innovative new Restful Jaw (RJ2) device appropriate for use with moderate/deep sedation or general anesthesia that will protect the jaw during 3rd molar removal and addresses important concerns. The RJ2 device attaches to the post of the headrest on the dental chair so its only contact with the patient is under and behind each side of her/his jaw. This design also allows for the jaw to be stabilized in an anterior position thus helping maintain a patent airway during moderate/deep sedation or general anesthesia. Finally, the proposed RJ2 device has a “quick-release” design for easy removal during an emergency. In Phase I of this project, the RJ2 device will be developed, assessed and modified with input from a team of oral and maxillofacial surgeons, their assistants and volunteers. Initial device prototypes will be evaluated in patients undergoing bilateral mandibular 3rd molar removal with moderate/deep sedation or general anesthesia. Surgeons and assistants will report on how easy and quick it is to place and remove the device, and how well it supports the jaw while allowing them to move the jaw as needed during their procedure. Phase II will consist of a randomized clinical trial (RCT) involving 294 subjects and 8 oral surgeons representing a tertiary care unit, a large staff model specialty group practice and a private practice. Patients having bilateral mandibular 3rd molar removal with moderate/deep sedation or general anesthesia will be randomized between: Usual Care (UC) with the patient's jaw hand-supported by an assistant, or Experimental Care (EC) with the RJ2 device supporting the jaw. During Phase II, patients and surgeons will complete pre- and post-operative questionnaires. The purpose of the RCT is to test the hypothesis that the risk of post-operative TMJD pain associated with EC is statistically less than with UC. Study group comparisons will be assessed at 1-, 3- and 6-month post-surgical follow-ups. We anticipate the RJ2 device will protect the patient's jaw, and lower the risk of TMJD pain.