Assessing a New Jaw Support Device During Third Molar Extractions

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Impacted Third Molar Tooth, Temporomandibular Disorder

Intervention / Treatment
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* Device: The Restful Jaw Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 18 to 30 years of age at time of enrollment; Willing to provide informed consent to be randomized to either using the device or not when having surgical removal of 3rd molars with moderate/deep sedation or general anesthesia; Requires surgical removal of bilateral mandibular 3rd molars with moderate/deep sedation or general anesthesia; concurrent maxillary 3rd molars removal allowed; American Society of Anesthesiologists (ASA) Physical Status category 1 (normal healthy patient) or Category 2 (patient with mild systemic disease); Available to be contacted for study purposes by e-mail, phone and/or text; Willing to provide contact information for one other person who will know the patient's whereabouts in the event the patient cannot be reached. This contact information must be different from the patient's contact information; Willing to comply with all study procedures and be available for the six month duration of data collection. Exclusion Criteria: In the past 3 months, reports the presence of TMD pain in their temples, jaw joints or jaw muscles; Contraindication(s) for moderate/deep sedation or general anesthesia; Any condition or situation the surgeon determines that would prevent the patient from participating in this study; Inability to understand study procedures or provide consent in English; Device does not fit mandible; Supernumerary 3rd molars present.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care (UC)<br>The study control is UC, which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block. | |
| Experimental: Experimental Care (EC)<br>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. | Device: The Restful Jaw Device<br>* 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.<br>* Other names: RJ2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Pain at Follow-up With Wide Opening, or Pain in the Temple, Jaw Joint or Jaw Muscles. | The primary outcome is the self-report of the occurrence of TMD pain post-baseline. All subjects were pain-free at baseline (i.e., pre-surgically) for TMD pain. TMD pain is deemed to have occurred if the subject's self report endorses at 1, 3 or 6 months post-baseline either or both of the following questions: 1. Pain in jaw when opening mouth wide or 2. Pain in temples, jaw joints or jaw muscles. | 1 Month | 
| Occurrence of Pain at Follow-up With Wide Opening, or Pain in the Temple, Jaw Joint or Jaw Muscles. | The primary outcome is the self-report of the occurrence of TMD pain post-baseline. All subjects were pain-free at baseline (i.e., pre-surgically) for TMD pain. TMD pain is deemed to have occurred if the subject's self report endorses at 1, 3 or 6 months post-baseline either or both of the following questions: 1. Pain in jaw when opening mouth wide or 2. Pain in temples, jaw joints or jaw muscles. | 3 Month | 
| Occurrence of Pain at Follow-up With Wide Opening, or Pain in the Temple, Jaw Joint or Jaw Muscles. | The primary outcome is the self-report of the occurrence of TMD pain post-baseline. All subjects were pain-free at baseline (i.e., pre-surgically) for TMD pain. TMD pain is deemed to have occurred if the subject's self report endorses at 1, 3 or 6 months post-baseline either or both of the following questions: 1. Pain in jaw when opening mouth wide or 2. Pain in temples, jaw joints or jaw muscles. | 6 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Pain Related TMD at Follow-up Using the TMD Pain Screener Questionnaire. | The occurrence of TMD pain post-baseline will be measured using the reliable and valid TMD Pain Screener Questionnaire. This subject self-report measure is comprised of 3 questions assessing the duration of TMD pain, presence of jaw pain or stiffness upon awakening, and activities that change TMD pain. TMD pain is deemed to have occurred if the subject's self report at 1, 3 or 6 months post-baseline is positive for the presence of TMD pain per the TMD Pain Screener. | 1 Month | 
| Occurrence of Pain Related TMD at Follow-up Using the TMD Pain Screener Questionnaire. | The occurrence of TMD pain post-baseline will be measured using the reliable and valid TMD Pain Screener Questionnaire. This subject self-report measure is comprised of 3 questions assessing the duration of TMD pain, presence of jaw pain or stiffness upon awakening, and activities that change TMD pain. TMD pain is deemed to have occurred if the subject's self report at 1, 3 or 6 months post-baseline is positive for the presence of TMD pain per the TMD Pain Screener. | 3 months | 
| Occurrence of Pain Related TMD at Follow-up Using the TMD Pain Screener Questionnaire. | The occurrence of TMD pain post-baseline will be measured using the reliable and valid TMD Pain Screener Questionnaire. This subject self-report measure is comprised of 3 questions assessing the duration of TMD pain, presence of jaw pain or stiffness upon awakening, and activities that change TMD pain. TMD pain is deemed to have occurred if the subject's self report at 1, 3 or 6 months post-baseline is positive for the presence of TMD pain per the TMD Pain Screener. | 6 Months | 
| Intensity of Pain at Follow-up Using the Characteristic Pain Index (CPI). | Subjects will compete at 1, 3 or 6 months post-baseline the reliable and valid Characteristic Pain Index (CPI) that measures pain intensity. It is comprised of 3 items assessed using numerical rating scales (0-10): current pain, worst pain and average pain. The final score is the average of these 3 items x 10. The CPI is part of the Graded Chronic Pain Scale (GCPS). | 1 Month | 
| Intensity of Pain at Follow-up Using the Characteristic Pain Index (CPI). | Subjects will compete at 1, 3 or 6 months post-baseline the reliable and valid Characteristic Pain Index (CPI) that measures pain intensity. It is comprised of 3 items assessed using numerical rating scales (0-10): current pain, worst pain and average pain. The final score is the average of these 3 items x 10. The CPI is part of the Graded Chronic Pain Scale (GCPS). | 3 Months | 
| Intensity of Pain at Follow-up Using the Characteristic Pain Index (CPI). | Subjects will compete at 1, 3 or 6 months post-baseline the reliable and valid Characteristic Pain Index (CPI) that measures pain intensity. It is comprised of 3 items assessed using numerical rating scales (0-10): current pain, worst pain and average pain. The final score is the average of these 3 items x 10. The CPI is part of the Graded Chronic Pain Scale (GCPS). | 6 Months | 
| Occurrence of TMJ Noise at Follow-up Using Self Report. | TMJ noise is deemed to have occurred at 1, 3 or 6 months post-baseline if the subject's self report endorses the question: Have you had any clicking or popping in your jaw joints? | 1 Month | 
| Occurrence of TMJ Noise at Follow-up Using Self Report. | TMJ noise is deemed to have occurred at 1, 3 or 6 months post-baseline if the subject's self report endorses the question: Have you had any clicking or popping in your jaw joints? | 3 Months | 
| Occurrence of TMJ Noise at Follow-up Using Self Report. | TMJ noise is deemed to have occurred at 1, 3 or 6 months post-baseline if the subject's self report endorses the question: Have you had any clicking or popping in your jaw joints? | 6 Months | 
| Change in Jaw Pain at Follow-up Using Self-report. | Subjects will report any change in jaw pain at 1, 3 or 6 months post-baseline using this question: How would you describe the change (if any) in your jaw pain since it started? The response options are: Much Worse (1), Slightly Worse(2), No Change(3), Slightly Better(4) or Much Better(5). | 1 Month | 
| Change in Jaw Pain at Follow-up Using Self-report. | Subjects will report any change in jaw pain at 1, 3 or 6 months post-baseline using this question: How would you describe the change (if any) in your jaw pain since it started? The response options are: Much Worse (1), Slightly Worse(2), No Change(3), Slightly Better(4) or Much Better(5). | 3 Months | 
| Change in Jaw Pain at Follow-up Using Self-report. | Subjects will report any change in jaw pain at 1, 3 or 6 months post-baseline using this question: How would you describe the change (if any) in your jaw pain since it started? The response options are: Much Worse (1), Slightly Worse(2), No Change(3), Slightly Better(4) or Much Better(5). | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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jaw support device, wisdom teeth, impacted, Temporomandibular Disorders