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

Restful Jaw 装置：在拔除第三磨牙期间支撑和保护下颌的新方法

• 批准号: 10045927
• 负责人: Karen Kloser
• 金额: $ 34.7万
• 依托单位: RESTFUL JAW COMPANY, LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-12-11 至 2020-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10045927
• 关键词: Acute; Address; Anesthetics; Anterior; Attention; Back; Bilateral; Bite; Breast; Caring; Chest; Chronic; Clinical Trials Design; Community Dentistry; Data; Dental; Dental Assistants; Dental Care; Device Designs; Devices; Emergency Situation; Excision; Feedback; Functional disorder; General Anesthesia; Goals; Group Meetings; Group Practice; Hand; Hypoxia; Incidence; Injury; Jaw; Lead; Legal patent; Mandible; Marketing; Medical; Medical emergency; Methods; Modeling; Muscle; Operative Surgical Procedures; Oral; Oral Surgeon; Oral Surgical Procedures; Oral cavity; Pain; Pain Disorder; Patient Monitoring; Patients; Pharmaceutical Preparations; Phase; Positioning Attribute; Postoperative Pain; Postoperative Period; Principal Investigator; Private Practice; Procedures; Process; Public Health; Questionnaires; Randomized; Randomized Clinical Trials; Reporting; Research Design; Risk; Sedation procedure; Shoulder; Side; Small Business Technology Transfer Research; Suction; Suggestion; Surgeon; Surgical Instruments; Temporomandibular Joint Disorders; Testing; Time; Tooth Extraction; Tooth structure; arm; comparison group; dental surgery; design; follow-up; improved; innovation; maxillofacial; medical specialties; oral surgery specialty; pain symptom; prevent; prototype; tertiary care; third molar extraction; treatment as usual; user centered design; volunteer; wisdom tooth; young adult

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.

项目摘要 牙科手术会因张开过长、过大或过多而导致下巴疼痛和不适。 施加在病人下巴上的向下的力。这些痛苦的症状可能是短暂的，也可能成为慢性的。 导致颞下颌肌和关节紊乱(TMJD)。拔除第三磨牙(智齿)有 与术后30%的TMJD相关。当口腔外科医生拔除下颌骨时 磨牙，患者通常有中度/深度镇静或全身麻醉，并有牙科助手 用手支撑下巴，以对抗与患者的下巴相关的向下的力 摘录。然而，对于助手来说，很难有效地对抗武力的大小和方向 放在患者的下巴上，服用镇静剂的患者无法紧张他们的肌肉来对抗这种力量。海流 对于服用镇静剂的患者，口腔外科医生不使用RESTful JAW(RJ1)外部颌骨支持装置， 在医疗或镇静紧急情况下，除非首先移动患者，否则不能移除该装置，并且 这会耽误治疗。我们已经完全重新设计了这种颌骨支撑装置，并提出了一种 创新的RESTful JAW(RJ2)设备，适用于中等/深度镇静或一般情况下的使用 在拔除第三颗磨牙的过程中保护下颌的麻醉，并解决了重要的问题。RJ2 该装置连接到牙椅上的头枕的柱子上，因此它与患者的唯一接触是在和 在她/他的下巴两侧。这种设计还允许将颌骨稳定在前方位置，从而 在中度/深度镇静或全身麻醉期间帮助维持呼吸道通畅。最后，提出了 RJ2设备具有“快速释放”设计，可在紧急情况下轻松拆卸。在这个项目的第一阶段， RJ2设备将根据口腔和颌面外科医生团队的意见进行开发、评估和改进， 他们的助手和志愿者。初始装置原型将在接受双侧手术的患者中进行评估 在中等/深度镇静或全身麻醉下拔除下颌第三磨牙。外科医生和助理 将报告设备的放置和移除有多容易和多快，以及它对下巴的支持程度 允许他们在手术过程中根据需要移动下巴。第二阶段将包括一项随机临床试验 试验(RCT)，涉及294名受试者和8名口腔外科医生，代表一家大型工作人员模式的三级护理病房 专业团体练习和私人练习。双侧下颌第三磨牙拔除手术的临床观察 中度/深度镇静或全身麻醉将随机分为：常规护理(UC)和患者的 由助手手动支撑的颌骨，或使用RJ2设备支撑颌骨的实验护理(EC)。在.期间 第二阶段，患者和外科医生将完成手术前和手术后的问卷调查。RCT的目的 是为了检验这样一种假设，即与EC相关的术后TMJD疼痛的风险在统计学上低于 与UC合作。研究组的比较将在术后1、3和6个月的随访中进行评估。我们 预计RJ2设备将保护患者的下颌，并降低TMJD疼痛的风险。

项目成果

Occurrence and Predictors of Postoperative Preauricular and Masticatory Muscle Pain Symptoms After Surgical Removal of Third Molars: A Single-Blind Randomized Controlled Trial Comparing Dental Assistants Supporting the Mandible and the Restful Jaw Device.

手术拔除第三磨牙后耳前和咀嚼肌疼痛症状的发生和预测：一项比较支持下颌骨和安宁下颌装置的牙科助理的单盲随机对照试验。

• DOI: 10.1016/j.joms.2023.09.021
• 发表时间: 2024
• 期刊: Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons
• 作者: Uppgaard,Rachel;Nadeau,Robert;Schiffman,EricL;Stiharu,Tudor;Johnson,KimberlyS;Hodges,JamesS;Velly,AnaMiriam
• 通讯作者: Velly,AnaMiriam