Assessing a New Jaw Support Device During Third Molar Extractions

NCT03975920 | Completed Results DMC FDA Device

• 2 other identifiers: DENT-2019-278114R44DE026663-02
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 4

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.

Conditions

Impacted Third Molar Tooth; Temporomandibular Disorder

Keywords

jaw support device; wisdom teeth; impacted; Temporomandibular Disorders

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• Occurrence of Pain Related TMD at Follow-up Using the TMD Pain Screener Questionnaire.

  1 Month

• Occurrence of Pain Related TMD at Follow-up Using the TMD Pain Screener Questionnaire.

  3 months

• Occurrence of Pain Related TMD at Follow-up Using the TMD Pain Screener Questionnaire.

  6 Months

• Intensity of Pain at Follow-up Using the Characteristic Pain Index (CPI).

  1 Month

• Intensity of Pain at Follow-up Using the Characteristic Pain Index (CPI).

  3 Months

Study Arms (2)

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.

Device: The Restful Jaw Device

Interventions

The Restful Jaw Device 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.

Also known as: RJ2

Experimental Care (EC)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead
• HealthPartners Institute: collaborator
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (4)

Metro Dentalcare Specialty Center

Burnsville, Minnesota, 55306, United States

Location

HealthPartners Eden Prairie Clinc

Eden Prairie, Minnesota, 55344, United States

Location

University of Minnesota School of Dentistry

Minneapolis, Minnesota, 55455, United States

Location

HealthPartners Como Clinic

Saint Paul, Minnesota, 55108, United States

Location

Related Publications (23)

• 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.

  PMID: 17666691 BACKGROUND

• 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.

  PMID: 17082281 BACKGROUND

• 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.

  PMID: 24524521 BACKGROUND

• 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.

  PMID: 18296615 BACKGROUND

• 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.

  PMID: 12097315 BACKGROUND

• 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.

  PMID: 19207447 BACKGROUND

• 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.

  PMID: 18351034 BACKGROUND

• 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.

  PMID: 12927621 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 3163728 BACKGROUND

• 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.

  PMID: 17134830 BACKGROUND

• 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.

  PMID: 10442939 BACKGROUND

• 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.

  PMID: 1054051 BACKGROUND

• 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.

  PMID: 3865133 BACKGROUND

• 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.

  PMID: 22991607 BACKGROUND

• Humphrey SP, Lindroth JE, Carlson CR. Routine dental care in patients with temporomandibular disorders. J Orofac Pain. 2002 Spring;16(2):129-34.

  PMID: 12043519 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 24064159 BACKGROUND

• Zucuskie T. A controlled clinical trial of the usefulness of an external mandibular support device during routine dental care. Minneapolis: University of Minnesota; 1996.

  BACKGROUND

• 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.

  PMID: 17189464 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 21965492 BACKGROUND

• Uppgaard R, Nadeau R, Schiffman EL, Stiharu T, Johnson KS, Hodges JS, Velly AM. Occurrence and Predictors of Postoperative Preauricular and Masticatory Muscle Pain Symptoms After Surgical Removal of Third Molars: A Single-Blind Randomized Controlled Trial Comparing Dental Assistants Supporting the Mandible and the Restful Jaw Device. J Oral Maxillofac Surg. 2024 Jan;82(1):6-18. doi: 10.1016/j.joms.2023.09.021. Epub 2023 Oct 5.

  PMID: 37898152 DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Tooth, Impacted

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Tooth Diseases

Limitations and Caveats

Limitations include that outcomes were self-reported, and patients were not examined at follow-up. Enrollment was impacted by stopping of patient recruitment at the beginning of the COVID pandemic.

Results Point of Contact

• Title: Dr. Eric Schiffman
• Organization: The Restful Jaw Company, LLC

schif001@umn.edu

(651)338-3344

Study Officials

• Eric Schiffman, DDS, MS

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: June 5, 2019
• Study Start: June 25, 2019
• Primary Completion: February 25, 2021
• Study Completion: February 25, 2021
• Last Updated: June 6, 2022
• Results First Posted: June 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 6 months after publication of the first paper.
• Access Criteria: These resources will be available to the NIDCR or to other approved investigators according to requirements imposed by the governing IRB and legal requirements, including HIPAA and Data Use Agreements.

Locations

US (4)