Impacted Third Molar ToothNCT03975920
Assessing a New Jaw Support Device During Third Molar Extractions
A study testing The Restful Jaw Device in people with Impacted Third Molar Tooth and Temporomandibular Disorder, run by University of Minnesota at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth, Temporomandibular Disorder
- What is being tested?
- The Restful Jaw Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 Jun 2019to 25 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Metro Dentalcare Specialty Center
Burnsville, Minnesota, 55306
HealthPartners Eden Prairie Clinc
Eden Prairie, Minnesota, 55344
University of Minnesota School of Dentistry
Minneapolis, Minnesota, 55455
HealthPartners Como Clinic
Saint Paul, Minnesota, 55108
About this study
Official title: The Restful Jaw Device: A New Way to Support and Protect the Jaw During Third Molar Extractions
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.
Read the 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.
- Being tested
- The Restful Jaw Device
- Keywords
- jaw support device, wisdom teeth, impacted, Temporomandibular Disorders
- Medical subject headings
- Temporomandibular Joint Disorders, Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Restful Jaw DeviceDevice
Also called RJ2
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care (UC) | No intervention | The study control is UC, which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block. |
| Experimental Care (EC) | Experimental | 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. Receives: Device: The Restful Jaw Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 Month
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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?
Measured: 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?
Measured: 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?
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start25 Jun 2019
- Primary completion25 Feb 2021
- Study completion25 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Impacted Third Molar ToothStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- HealthPartners Institute, National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Eric Schiffman, DDS, MS, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975920
- Sponsor's protocol ID
- DENT-2019-27811
- Other IDs
- 4R44DE026663-02
- Status last verified
- May 2022
- First submitted
- 21 May 2019
- Last updated
- 6 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: To facilitate the conduct of further analyses with the data we collect, we will create Limited Data Sets from the completed project in a manner consistent with human subject protection and HIPAA privacy regulations.
Publications
Friedman JW. The prophylactic extraction of third molars: a public health hazard. Am J Public Health. 2007 Sep;97(9):1554-9. doi: 10.2105/AJPH.2006.100271. Epub 2007 Jul 31.
PubMed 17666691Huang GJ, Rue TC. Third-molar extraction as a risk factor for temporomandibular disorder. J Am Dent Assoc. 2006 Nov;137(11):1547-54. doi: 10.14219/jada.archive.2006.0090.
PubMed 17082281Huang GJ, Cunha-Cruz J, Rothen M, Spiekerman C, Drangsholt M, Anderson L, Roset GA. A prospective study of clinical outcomes related to third molar removal or retention. Am J Public Health. 2014 Apr;104(4):728-34. doi: 10.2105/AJPH.2013.301649. Epub 2014 Feb 13.
PubMed 24524521Huang GJ, Drangsholt MT, Rue TC, Cruikshank DC, Hobson KA. Age and third molar extraction as risk factors for temporomandibular disorder. J Dent Res. 2008 Mar;87(3):283-7. doi: 10.1177/154405910808700313.
PubMed 18296615Huang GJ, LeResche L, Critchlow CW, Martin MD, Drangsholt MT. Risk factors for diagnostic subgroups of painful temporomandibular disorders (TMD). J Dent Res. 2002 Apr;81(4):284-8. doi: 10.1177/154405910208100412.
PubMed 12097315Juhl GI, Jensen TS, Norholt SE, Svensson P. Incidence of symptoms and signs of TMD following third molar surgery: a controlled, prospective study. J Oral Rehabil. 2009 Mar;36(3):199-209. doi: 10.1111/j.1365-2842.2008.01925.x.
PubMed 19207447Akhter R, Hassan NM, Ohkubo R, Tsukazaki T, Aida J, Morita M. The relationship between jaw injury, third molar removal, and orthodontic treatment and TMD symptoms in university students in Japan. J Orofac Pain. 2008 Winter;22(1):50-6.
PubMed 18351034Velly AM, Gornitsky M, Philippe P. Contributing factors to chronic myofascial pain: a case-control study. Pain. 2003 Aug;104(3):491-499. doi: 10.1016/S0304-3959(03)00074-5.
PubMed 12927621Okeson JP. Bell's orofacial pains: The clinical management of orofacial pain, sixth edition. Vol 6. Illinois: Quintessence Publishing; 2005.
Pullinger AG, Monteiro AA. History factors associated with symptoms of temporomandibular disorders. J Oral Rehabil. 1988 Mar;15(2):117-24. doi: 10.1111/j.1365-2842.1988.tb00760.x.
PubMed 3163728LeResche L, Mancl LA, Drangsholt MT, Huang G, Von Korff M. Predictors of onset of facial pain and temporomandibular disorders in early adolescence. Pain. 2007 Jun;129(3):269-278. doi: 10.1016/j.pain.2006.10.012. Epub 2006 Nov 28.
PubMed 17134830Plesh O, Gansky SA, Curtis DA, Pogrel MA. The relationship between chronic facial pain and a history of trauma and surgery. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1999 Jul;88(1):16-21. doi: 10.1016/s1079-2104(99)70187-3.
PubMed 10442939Butler JH, Folke LE, Bandt CL. A descriptive survey of signs and symptoms associated with the myofascial pain-dysfunction syndrome. J Am Dent Assoc. 1975 Mar;90(3):635-9. doi: 10.14219/jada.archive.1975.0147.
PubMed 1054051Fricton JR, Kroening R, Haley D, Siegert R. Myofascial pain syndrome of the head and neck: a review of clinical characteristics of 164 patients. Oral Surg Oral Med Oral Pathol. 1985 Dec;60(6):615-23. doi: 10.1016/0030-4220(85)90364-0.
PubMed 3865133Sahebi S, Moazami F, Afsa M, Nabavi Zade MR. Effect of lengthy root canal therapy sessions on temporomandibular joint and masticatory muscles. J Dent Res Dent Clin Dent Prospects. 2010 Summer;4(3):95-7. doi: 10.5681/joddd.2010.024. Epub 2010 Sep 16.
PubMed 22991607
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Restful Jaw Device: A New Way to Support and Protect the Jaw During Third Molar Extractions
- ClinicalTrials.gov ID
- NCT03975920
- Acronym / sponsor ID
- DENT-2019-27811
- Keywords
- jaw support device, wisdom teeth, impacted, Temporomandibular Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- HealthPartners Institute, National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 5 Jun 2019 (actual)
- Results
- Posted 6 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual Care (UC) | No intervention | –The study control is UC, which involves the dental assistant supporting the jaw during the extractions with concurrent use of a bite block. |
| Experimental Care (EC) | Experimental | Device: The Restful Jaw DeviceThe 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Restful Jaw DeviceAlso: RJ2The 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. | Device | Experimental Care (EC) |
Primary outcome
Occurrence of Pain at Follow-up With Wide Opening, or Pain in the Temple, Jaw Joint or Jaw Muscles.
Time frame: 1 Month
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.
Occurrence of Pain at Follow-up With Wide Opening, or Pain in the Temple, Jaw Joint or Jaw Muscles.
Time frame: 3 Month
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.
Occurrence of Pain at Follow-up With Wide Opening, or Pain in the Temple, Jaw Joint or Jaw Muscles.
Time frame: 6 Month
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.
12 secondary outcomes
Occurrence of Pain Related TMD at Follow-up Using the TMD Pain Screener Questionnaire.
Time frame: 1 Month
Occurrence of Pain Related TMD at Follow-up Using the TMD Pain Screener Questionnaire.
Time frame: 3 months
Occurrence of Pain Related TMD at Follow-up Using the TMD Pain Screener Questionnaire.
Time frame: 6 Months
Intensity of Pain at Follow-up Using the Characteristic Pain Index (CPI).
Time frame: 1 Month
Intensity of Pain at Follow-up Using the Characteristic Pain Index (CPI).
Time frame: 3 Months
Intensity of Pain at Follow-up Using the Characteristic Pain Index (CPI).
Time frame: 6 Months
Occurrence of TMJ Noise at Follow-up Using Self Report.
Time frame: 1 Month
Occurrence of TMJ Noise at Follow-up Using Self Report.
Time frame: 3 Months
Occurrence of TMJ Noise at Follow-up Using Self Report.
Time frame: 6 Months
Change in Jaw Pain at Follow-up Using Self-report.
Time frame: 1 Month
Change in Jaw Pain at Follow-up Using Self-report.
Time frame: 3 Months
Change in Jaw Pain at Follow-up Using Self-report.
Time frame: 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17666691Friedman JW. The prophylactic extraction of third molars: a public health hazard. Am J Public Health. 2007 Sep;97(9):1554-9. doi: 10.2105/AJPH.2006.100271. Epub 2007 Jul 31.
- Background: PubMed 17082281Huang GJ, Rue TC. Third-molar extraction as a risk factor for temporomandibular disorder. J Am Dent Assoc. 2006 Nov;137(11):1547-54. doi: 10.14219/jada.archive.2006.0090.
- Background: PubMed 24524521Huang GJ, Cunha-Cruz J, Rothen M, Spiekerman C, Drangsholt M, Anderson L, Roset GA. A prospective study of clinical outcomes related to third molar removal or retention. Am J Public Health. 2014 Apr;104(4):728-34. doi: 10.2105/AJPH.2013.301649. Epub 2014 Feb 13.
- Background: PubMed 18296615Huang GJ, Drangsholt MT, Rue TC, Cruikshank DC, Hobson KA. Age and third molar extraction as risk factors for temporomandibular disorder. J Dent Res. 2008 Mar;87(3):283-7. doi: 10.1177/154405910808700313.
- Background: PubMed 12097315Huang GJ, LeResche L, Critchlow CW, Martin MD, Drangsholt MT. Risk factors for diagnostic subgroups of painful temporomandibular disorders (TMD). J Dent Res. 2002 Apr;81(4):284-8. doi: 10.1177/154405910208100412.
- Background: PubMed 19207447Juhl GI, Jensen TS, Norholt SE, Svensson P. Incidence of symptoms and signs of TMD following third molar surgery: a controlled, prospective study. J Oral Rehabil. 2009 Mar;36(3):199-209. doi: 10.1111/j.1365-2842.2008.01925.x.
- Background: PubMed 18351034Akhter R, Hassan NM, Ohkubo R, Tsukazaki T, Aida J, Morita M. The relationship between jaw injury, third molar removal, and orthodontic treatment and TMD symptoms in university students in Japan. J Orofac Pain. 2008 Winter;22(1):50-6.
- Background: PubMed 12927621Velly AM, Gornitsky M, Philippe P. Contributing factors to chronic myofascial pain: a case-control study. Pain. 2003 Aug;104(3):491-499. doi: 10.1016/S0304-3959(03)00074-5.
- BackgroundOkeson JP. Bell's orofacial pains: The clinical management of orofacial pain, sixth edition. Vol 6. Illinois: Quintessence Publishing; 2005.
- Background: PubMed 3163728Pullinger AG, Monteiro AA. History factors associated with symptoms of temporomandibular disorders. J Oral Rehabil. 1988 Mar;15(2):117-24. doi: 10.1111/j.1365-2842.1988.tb00760.x.
- Background: PubMed 17134830LeResche L, Mancl LA, Drangsholt MT, Huang G, Von Korff M. Predictors of onset of facial pain and temporomandibular disorders in early adolescence. Pain. 2007 Jun;129(3):269-278. doi: 10.1016/j.pain.2006.10.012. Epub 2006 Nov 28.
- Background: PubMed 10442939Plesh O, Gansky SA, Curtis DA, Pogrel MA. The relationship between chronic facial pain and a history of trauma and surgery. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1999 Jul;88(1):16-21. doi: 10.1016/s1079-2104(99)70187-3.
- Individual participant dataSharing planned: Yes. To facilitate the conduct of further analyses with the data we collect, we will create Limited Data Sets from the completed project in a manner consistent with human subject protection and HIPAA privacy regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Schiffman, DDS, MS principal investigator
University of Minnesota
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Restful Jaw Device in people with Impacted Third Molar Tooth and Temporomandibular Disorder, run by University of Minnesota at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Pain at Follow-up With Wide Opening, or Pain in the Temple, Jaw Joint or Jaw Muscles. (time frame: 1 Month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03975920, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.