Assessing a New Jaw Support Device During Third Molar Extractions
Condition: Impacted Third Molar Tooth; Temporomandibular Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Tooth, Impacted
Study type: Interventional

Summary: 
      During mandibular 3rd molar (wisdom tooth) extractions, when a downward force is placed on
      the patient's jaw, the patient must tense his/her jaw muscles to oppose it. Patients under
      moderate/deep sedation or general anesthesia cannot tense their muscles to counter this
      downward force to prevent injury to the jaw including the temporomandibular joint (TMJ). Bite
      blocks hold the patient's mouth open but do not counter this downward force on the mandible.
      Currently, oral and maxillofacial surgeons (OMSs) when surgically removing 3rd molars (wisdom
      teeth) with moderate/deep sedation or general anesthesia have a dental assistant that stands
      behind the chair and places their hands on both sides of the jaw to support it and oppose the
      downward force on the patient's jaw during the extractions. It is hard for the dental
      assistant to maintain support while anticipating the direction and amount of force placed by
      the OMS on the patient's jaw during the surgical removal. This may explain the finding that
      almost a quarter of new onset TMD cases in young adults is associated with 3rd molar removal.
      This study will look at the use of a jaw support device to provide a stable counterforce to
      downward forces on the jaw, thus preventing jaw hyperextension and injury to the jaw.
    

Detailed description: 
      Dental procedures can cause jaw pain, discomfort and fatigue from opening the mouth too long
      or too wide, or by placing too much force on the jaw. (1-15) Opening too wide can also cause
      hyperextension of the jaw. During and after long dental procedures, patients frequently
      report jaw pain, fatigue, or discomfort. This pain and dysfunction characterizes
      temporomandibular disorders (TMD), which can be short-term or may become chronic. TMD
      occurrence is frequently associated with trauma from dental procedures, including 3rd molar
      extractions. (1-15) Also, dental procedures may aggravate pre-existing subclinical TMD
      symptoms. (16)

      When a downward force is placed on the patient's jaw to surgically remove the mandibular
      (lower) 3rd molars, the patient must tense his/her jaw muscles to oppose it. This can result
      in jaw pain, discomfort or fatigue, especially if the force is high or prolonged. Patients
      under moderate/deep sedation or general anesthesia cannot tense their muscles to counter this
      downward force to prevent injury to the jaw. Bite blocks hold the patient's mouth open but do
      nothing to counter this downward force on the jaw. Opening a patient's mouth too wide can
      cause jaw hyperextension; a long extraction procedure time can also lead to injury of the
      jaw. Currently, oral and maxillofacial surgeons (OMSs) when surgically removing 3rd molars
      (wisdom teeth) with moderate/deep sedation or general anesthesia have at least 2 dental
      assistants present. The first dental assistant provides suction and gives the surgical
      instruments to the surgeon. The second dental assistant is a certified anesthesia dental
      assistant who monitors the patient's vitals as well as oxygen and carbon dioxide levels while
      providing the patient with medications intravenously. This second dental assistant also
      inserts the bite block and then stands behind the chair and places their hands on both sides
      of the jaw to support it and oppose the downward force on the patient's jaw during the
      extractions. If additional intravenous medications are needed during the surgery, the surgery
      has to stop (lost time) and the OMS or the first dental assistant supports the jaw until the
      second dental assistant completes the medication administration. Based on clinical
      experience, the second dental assistant often experiences fatigue and pain in their hands,
      arms, neck and shoulders during long or difficult procedures, which can affect his/her
      ability to support the jaw. Given the second dental assistant's many duties and
      responsibilities, it is hard for the assistant to provide constant good jaw support while
      anticipating the direction and amount of force placed by the OMS on the patient's jaw during
      3rd molar surgical removal. This may explain the finding that almost a quarter of new onset
      of TMD cases in young adults is associated with 3rd molar removal. This patient safety issue
      can be addressed during 3rd molar surgical removal by using a bite block to hold the mouth
      open and concurrently using a jaw support device under the jaw to provide a stable counter
      force to downward forces on the jaw, thus preventing jaw hyperextension and injury to the
      jaw. This would also free the second dental assistant from holding the jaw so he/she can
      concentrate on his/her other duties, which would improve patient safety.

      In this two-arm parallel randomized clinical trial design, 294 patients undergoing 3rd molar
      extractions with moderate/deep sedation or general anesthesia will be randomly allocated to
      Usual Care (UC) or Experimental Care (EC).

      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 an obtain consent. The jaw device will be placed for those who are
      randomized into the EC group. The OMS will follow their standard protocol for removal of the
      teeth. The only change will be that the dental assistant standing behind the chair will be
      present at all time 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.

      Patients will report temporomandibular disorders (TMD) pain via questionnaires at baseline
      and at the 1-, 3-, and 6-month follow-up time points via email, phone and/or text.
    

Intervention name(s): The 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. This device replicates the dental assistant in holding the jaw during dental procedures.
Other intervention name(s): RJ2
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In this two-arm parallel randomized clinical trial (RCT) design, 294 patients undergoing 3rd molar extractions with moderate/deep sedation or general anesthesia will be randomly allocated to Usual Care (UC) or Experimental Care (EC). The study intervention for EC is use of the Restful Jaw version 2 (RJ2) device, which supports the jaw during the extractions, with concurrent use of a bite block. The study control is UC, which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block.
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: jaw support device; wisdom teeth; impacted; Temporomandibular Disorders