Clinical trial NCT03512769: Feasibility Testing of a New Way to Support the Jaw During 3rd Molar Extractions
Official title: The Restful Jaw Device: A New Way to Support and Protect the Jaw During Third Molar Extractions; Feasibility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Impacted Third Molar Tooth
Temporomandibular Joint Dysfunction Syndrome
Keywords: jaw support device, third molars, wisdom teeth, partially erupted or impacted
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: HealthPartners Institute
First posted: 2018-05-01
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that present to the participating oral and maxillofacial surgeons' office for mandibular 3rd molar surgical removal with moderate/deep sedation

Brief summary: Cross sectional observational study to assess the feasibility of using the functional prototype of the restful jaw support device to support the jaw when extracting mandibular 3rd molars using moderate/deep sedation. An additional meeting(s) will occur, after the oral and maxillofacial surgeons (OMS) have completed all treatment procedures utilizing the device and surveys are completed, to provide feedback on how the device performed.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The feasibility will be assessed by query of the surgeons utilizing the device (questionnaire). This will be done after 4 patient experiences in conjunction with surgical procedure.
timeFrame: 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
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