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Assessing a New Jaw Support Device During Third Molar Extractions

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ClinicalTrials.gov Identifier: NCT03975920
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
HealthPartners Institute
Information provided by (Responsible Party):
James Switft, University of Minnesota, MN

Brief 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.

Condition or disease Intervention/treatment Phase
Impacted Third Molar Tooth Temporomandibular Disorder Device: The Restful Jaw Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 294 participants
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)
Masking Description: In this RCT, it is not feasible to blind patients, surgeons, or dental assistants to treatment after the intervention assignments have occurred, so they will not be blinded. It is, however, feasible to mask the sequence of treatment assignments until the moment each assignment is made, and this will be done, as described in Section 5.4.1, above.
Primary Purpose: Prevention
Official Title: The Restful Jaw Device: A New Way to Support and Protect the Jaw During Third Molar Extractions
Actual Study Start Date : June 25, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : August 31, 2020

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.
Device: The Restful Jaw Device
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 Name: RJ2




Primary Outcome Measures :
  1. Change from Baseline Incidence of TMD pain occurring with 1. wide opening of the mouth, or 2. presence of pain in temples, jaw joints or jaw muscles at 1, 3 and 6 months. [ Time Frame: 1, 3 and 6 months. ]
    The primary outcome is the incidence of 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.


Secondary Outcome Measures :
  1. Change from Baseline Incidence of TMD pain as measured with the TMD Pain Screener Questionnaire at 1, 3 and 6 months [ Time Frame: 1, 3 and 6 months. ]
    The incidence of self-report of TMD pain 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 jaw pain, presence of jaw pain or stiffness upon awakening, and activities that change jaw pain.

  2. Change from Baseline Incidence of TMD Pain Disability as measured with the Graded Chronic Pain Scale. (GCPS) at 1, 3 and 6 months. [ Time Frame: 1, 3 and 6 months. ]
    The reliable and valid Graded Chronic Pain Scale (GCPS) measures subject-reported pain intensity and pain-related activity interference, and is used to classify subjects into "chronic pain grades" based on pain and interference levels. The pain intensity subscale is assessed using the Characteristic Pain Index (CPI) which measures pain intensity and is comprised of 3 items assessed using numerical rating scales (0-10): current pain, worst pain and average pain. The pain interference sub-scale is comprised of 3 items assessed using numerical rating scales (0-10): interference with 1. daily activities, 2. recreational, social and family activities, and 3. ability to work. A final question measures the number of disability days in a defined time frame. "Disability days" is defined as how many days the subject has been kept from their usual activities (work, school or housework) due to pain. The composite score allows for assigning subjects to having low or high disability.

  3. Change from Baseline TMD Pain Intensity as measured with the Characteristic Pain Index (CPI) at 1, 3 and 6 months. [ Time Frame: 1, 3 and 6 months. ]
    The reliable and valid Characteristic Pain Index (CPI) measures pain intensity and is comprised of 3 items assessed using numerical rating scales (0-10): current pain, worst pain and average pain. The CPI is part of the Graded Chronic Pain Scale (GCPS).

  4. Change from Baseline Incidence of TMJ noise using subject self-report at 1, 3 and 6 months. [ Time Frame: 1, 3 and 6 months. ]
    TMD noise is deemed to have occurred if the subject's self report endorses the question: Have you had any clicking or popping in your jaw joints?

  5. Change from Baseline for change in jaw pain using subject self-report at 1, 3 and 6 months [ Time Frame: 1, 3 and 6 months. ]
    Change in jaw pain is assessed using the following question: How would you describe the change (if any) in your jaw pain since it started? The response options are: Much Worse, Slightly Worse, No Change, Slightly Better or Much Better.

  6. Descriptive summary of the experiences of surgeons and dental assistants with the new device. [ Time Frame: 4 months and 9 months. ]
    A final secondary outcome is descriptive: a summary of the experiences and opinions of the study surgeons and dental assistants of the new device. This will be assessed midway through subject recruitment and at the end of study recruitment for each surgeon and assistant.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975920


Contacts
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Contact: Kimberly S Johnson, MDH 952.967.5276 kimberly.s.johnson@healthpartners.com

Locations
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United States, Minnesota
Dakota Valley Oral & Maxillofacial Surgery Not yet recruiting
Burnsville, Minnesota, United States, 55337
Contact: Kimberly Johnson, MDH    651-210-7077    kimberly.s.johnson@healthpartners.com   
Sub-Investigator: Patricia A Rake, DDS         
Sub-Investigator: Cassandra Stacy, DDS         
HealthPartners Eden Prairie Clinc Recruiting
Eden Prairie, Minnesota, United States, 55344
Contact: Kimberly Johnson, MDH    651-210-7077    kimberly.s.johnson@healthpartners.com   
Sub-Investigator: Elisabeth Peterson, DDS         
University of Minnesota School of Dentistry Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Kimberly S Johnson, MDH    651-210-7077    kimberly.s.johnson@healthpartners.com   
Principal Investigator: James Q Swift, DDS         
Sub-Investigator: Robert Nadeau, DDS         
Sub-Investigator: Rachel Uppgaard, DDS         
HealthPartners Como Clinic Recruiting
Saint Paul, Minnesota, United States, 55108
Contact: Kimberly Johnson, MDH    651-210-7077    kimberly.s.johnson@healthpartners.com   
Sub-Investigator: Robert D Rupprecht, DDS         
Sub-Investigator: Elisabeth Peterson, DDS         
Sponsors and Collaborators
University of Minnesota, MN
HealthPartners Institute

Publications:
Okeson JP. Bell's orofacial pains: The clinical management of orofacial pain, sixth edition. Vol 6. Illinois: Quintessence Publishing; 2005.
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
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.

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Responsible Party: James Switft, Site Principal Investigator, University of Minnesota, MN
ClinicalTrials.gov Identifier: NCT03975920     History of Changes
Other Study ID Numbers: 5987
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by James Switft, University of Minnesota, MN:
jaw support device
wisdom teeth
impacted
Temporomandibular Disorders

Additional relevant MeSH terms:
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Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Tooth, Impacted
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Tooth Diseases