THE RESTFUL JAW CO LLC — Department of Health and Human Services STTR Phase I: NIDCR

Description

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 patientandapos 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 incidence of post operative TMJD When oral surgeons extract mandibular rd 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 patientandapos 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 patientandapos s jaw and sedated patients cannot tense their muscles to counter this force The current Restful Jaw RJ 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 RJ device appropriate for use with moderate deep sedation or general anesthesia that will protect the jaw during rd molar removal and addresses important concerns The RJ 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 RJ device has a quick release design for easy removal during an emergency In Phase I of this project the RJ 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 rd 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 subjects and oral surgeons representing a tertiary care unit a large staff model specialty group practice and a private practice Patients having bilateral mandibular rd molar removal with moderate deep sedation or general anesthesia will be randomized between Usual Care UC with the patientandapos s jaw hand supported by an assistant or Experimental Care EC with the RJ 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 and month post surgical follow ups We anticipate the RJ device will protect the patientandapos s jaw and lower the risk of TMJD pain Project Narrative Third molar extractions can cause acute and chronic jaw pain and discomfort from opening too long too wide or having too much force placed on the patientandapos s jaw This study will develop and test an innovative device to support the jaw during such dental surgery This device is designed to improve patient comfort during surgery and provide a new method to protect the patientandapos s jaw from injury that may lead to chronic jaw pain