Feasibility Testing of a New Way to Support the Jaw During 3rd Molar Extractions

Cross sectional observational study assesses the feasibility of OMS and dental assistants
using the jaw support device during mandibular 3rd molar extractions with moderate/deep
sedation.

Patients presenting for surgical removal of 3rd molars will be invited to participate in the
study at the time of their oral surgery consult. The OMS will determine if the patient meets
eligibility criteria, explain the study and invite them to participate. At the time of 3rd
molar removal, the OMS and their dental assistants will follow their standard procedures for
obtaining consent from patients for 3rd molar removal with moderate/deep sedation. In
addition, they will confirm the patient's interest to participate in the study, ask if they
have any questions and obtain consent. A dental assistant will place the jaw support device
and recheck the jaw support tightening mechanism once the positioning is comfortable for the
patient. The dental assistant will recheck the jaw support tightening mechanism before the
procedure begins.

The OMS will use their standard protocol for removal of the teeth. The only change will be
that a dental assistant who typically stands behind the dental chair and supports the
mandible with their hands and moves the jaw as indicated by the OMS will instead place and
secure the device to support the jaw. A dental assistant standing behind the chair will be
present at all times to readjust the device position as needed or remove the device as
indicated. The default in the case of device malfunction is for the device to fall away from
the patient and the dental assistant will be immediately available to take over supporting
the patient's jaw with their hands, which is one of their standard responsibilities when the
device is not used.

Both the OMS and any dental assistant(s) assisting in the procedure(s), when the device is
utilized, will each complete a survey about their experience with the jaw support device once
they have completed surgical removal with moderate/deep sedation of mandibular 3rd molars in
4 patients.

An additional meeting(s) will occur, after the OMS have completed all treatment procedures
utilizing the device and surveys are completed, to provide feedback on how the device
performed. This information will inform Phase II of this study, a randomized controlled
clinical trial.

Inclusion Criteria:

- Is between 18 to 24 years of age.

- Requires surgical removal of bilateral mandibular 3rd molars (concurrent maxillary 3rd
molar extractions allowed).

- Will consent to have 3rd molar surgical removal with the device supporting the
mandible.

- Indication for moderate/deep sedation and medically able to tolerate sedation.

- American Society of Anesthesiologists (ASA) Physical Status Category I (healthy
patient) and Category II (patients with mild systemic disease).

Exclusion Criteria:

• Any condition or situation that the surgeon feels would prevent the patient from
participating in the study.