- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03975920
Assessing a New Jaw Support Device During Third Molar Extractions
The Restful Jaw Device: A New Way to Support and Protect the Jaw During Third Molar Extractions
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Burnsville, Minnesota, United States, 55306
- Metro Dentalcare Specialty Center
-
Eden Prairie, Minnesota, United States, 55344
- HealthPartners Eden Prairie Clinc
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota School of Dentistry
-
Saint Paul, Minnesota, United States, 55108
- HealthPartners Como Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual Care (UC)
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)
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 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 Names:
|
What is the study measuring?
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.
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.
|
1 Month
|
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.
|
3 Month
|
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.
|
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.
Time Frame: 1 Month
|
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.
Time Frame: 3 months
|
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.
Time Frame: 6 Months
|
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).
Time Frame: 1 Month
|
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).
Time Frame: 3 Months
|
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).
Time Frame: 6 Months
|
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.
Time Frame: 1 Month
|
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.
Time Frame: 3 Months
|
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.
Time Frame: 6 Months
|
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.
Time Frame: 1 Month
|
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.
Time Frame: 3 Months
|
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.
Time Frame: 6 Months
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Eric Schiffman, DDS, MS, University of Minnesota
Publications and helpful links
General Publications
- Schiffman EL, Look JO, Hodges JS, Swift JQ, Decker KL, Hathaway KM, Templeton RB, Fricton JR. Randomized effectiveness study of four therapeutic strategies for TMJ closed lock. J Dent Res. 2007 Jan;86(1):58-63. doi: 10.1177/154405910708600109. Erratum In: J Dent Res. 2013 Jan;92(1):98.
- Gonzalez YM, Schiffman E, Gordon SM, Seago B, Truelove EL, Slade G, Ohrbach R. Development of a brief and effective temporomandibular disorder pain screening questionnaire: reliability and validity. J Am Dent Assoc. 2011 Oct;142(10):1183-91. doi: 10.14219/jada.archive.2011.0088.
- Fricton 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.
- 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.
- Huang 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.
- Huang 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.
- Huang 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.
- Huang 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.
- Juhl 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.
- Akhter 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.
- Velly 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.
- Okeson 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.
- LeResche 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.
- Plesh 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.
- Butler 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.
- Sahebi 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.
- Humphrey SP, Lindroth JE, Carlson CR. Routine dental care in patients with temporomandibular disorders. J Orofac Pain. 2002 Spring;16(2):129-34.
- American Association of Oral and Maxillofacial Surgeons. Parameters of care: Clinical and practice guidelines for oral and maxillofacial surgeons. 2012. Available at http://www.mfch.cz/doc/ParCare2012Complete.pdf
- Fernandes P, Velly AM, Anderson GC. A randomized controlled clinical trial evaluating the effectiveness of an external mandibular support device during dental care for patients with temporomandibular disorders. Gen Dent. 2013 Sep-Oct;61(6):26-31.
- Zucuskie T. A controlled clinical trial of the usefulness of an external mandibular support device during routine dental care. Minneapolis: University of Minnesota; 1996.
- Lan KKG, DeMets DL. Design and analysis of group sequential tests based on the type 1 error spending rate function. Biometrika. 1987;74:149- 154.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DENT-2019-27811
- 4R44DE026663-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Temporomandibular Disorder
-
CES UniversityCompletedTemporomandibular Disorder | Children, Only | Pain Disorder | Joint Disorder, Temporomandibular
-
University of AlcalaCompletedTemporomandibular DisorderSpain
-
University of Nove de JulhoUnknownTemporomandibular DisorderBrazil
-
Beirut Arab UniversityRecruitingTemporomandibular DisorderLebanon
-
Riphah International UniversityRecruitingTemporomandibular DisorderPakistan
-
Hams Hamed AbdelrahmanCompletedTemporomandibular DisorderEgypt
-
Centre Hospitalier Universitaire de NiceCompleted
-
Federal University of Rio Grande do SulCompletedTemporomandibular Disorder
-
University of Nove de JulhoCompleted
-
University of Sao PauloConselho Nacional de Desenvolvimento Científico e TecnológicoCompletedTemporomandibular DisorderBrazil
Clinical Trials on The Restful Jaw Device
-
University of MinnesotaHealthPartners InstituteCompletedTemporomandibular Joint Dysfunction Syndrome | Impacted Third Molar ToothUnited States
-
United States Naval Medical Center, San DiegoCompleted
-
Taipei Medical UniversityNot yet recruiting
-
Hospices Civils de LyonNot yet recruitingMaxillofacial AbnormalitiesFrance
-
Vanderbilt University Medical CenterCompletedHead and Neck Cancer | TrismusUnited States
-
Sanliurfa Mehmet Akif Inan Education and Research...CompletedDepressive Disorder | Restless Legs Syndrome | Anemia of Chronic Kidney Disease | Hemodialysis-Associated Pruritus | Malnutrition-Inflammation-Cachexia SyndromeTurkey
-
Memorial Sloan Kettering Cancer CenterCompleted
-
Darma Inc.Virginia Commonwealth UniversityCompletedVital Sign MonitoringUnited States
-
Endogenex, Inc.Active, not recruitingGlucose Metabolism Disorders | Diabetes Mellitus, Type 2 | Diabetes Mellitus | Endocrine System Diseases | Diabetes | Metabolic Disease | Diabetes Type 2United States
-
Skelmet IncMassachusetts Eye and Ear InfirmaryCompleted