Feasibility Testing of a New Way to Support the Jaw During 3rd Molar Extractions
Condition: Impacted Third Molar Tooth; Temporomandibular Joint Dysfunction Syndrome
MeSH terms: Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Tooth, Impacted
Study type: Observational

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.
    

Intervention name(s): Restful Jaw Device
Intervention type(s): Device
Intervention description(s): 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.
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
      
Keywords: jaw support device, third molars, wisdom teeth, partially erupted or impacted