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

项目总结

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.