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

August 12, 2020 updated by: University of Minnesota

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 24 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 3-6 months
Surgeons satisfaction with utilization of the device.
3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

HealthPartners Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2018

Primary Completion (ACTUAL)

December 30, 2018

Study Completion (ACTUAL)

December 30, 2018

Study Registration Dates

First Submitted

March 27, 2018

First Submitted That Met QC Criteria

April 17, 2018

First Posted (ACTUAL)

May 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 13, 2020

Last Update Submitted That Met QC Criteria

August 12, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2854

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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