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

NCT03512769 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 19

Last updated 2020-08-13

No results posted yet for this study

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.

Conditions

  • Impacted Third Molar Tooth
  • Temporomandibular Joint Dysfunction Syndrome

Interventions

DEVICE

Restful Jaw Device

The Restful Jaw device is used to support the jaw during dental procedures including surgical removal of 3rd molars (wisdom teeth) with sedation. The device is designed to counter the downward forces placed on the mandible by clinicians during dental procedures and prevent jaw hyperextension (opening too wide) while providing a secure, stable jaw position. When 3rd molar teeth are surgically removed with sedation, a dental assistant stands behind the dental chair and supports the patient's jaw with both hands under the patient's jaw. If needed, the dental assistant also holds the jaw in a slightly forward position to maintain an open airway. This device replicates the dental assistant in holding the jaw during dental procedures.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2018-12-30
Completion
2018-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03512769 on ClinicalTrials.gov