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

> **NIH NIH R44** · RESTFUL JAW COMPANY, LLC · 2020 · $347,023

## Abstract

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 associ...

## Key facts

- **NIH application ID:** 10045927
- **Project number:** 3R44DE026663-03S1
- **Recipient organization:** RESTFUL JAW COMPANY, LLC
- **Principal Investigator:** Karen Kloser
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $347,023
- **Award type:** 3
- **Project period:** 2019-12-11 → 2020-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10045927

## Citation

> US National Institutes of Health, RePORTER application 10045927, The Restful Jaw Device: A New Way to Support and Protect the Jaw During Third Molar Extractions (3R44DE026663-03S1). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10045927. Licensed CC0.

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