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TMJ NextGeneration(TM) Feasibility Study (Bruxoff)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02257320
Recruitment Status : Completed
First Posted : October 6, 2014
Last Update Posted : June 10, 2015
Cardiox Corporation
Information provided by (Responsible Party):
Cardiox Corporation ( TMJ Health )

Brief Summary:
The study is an open-label, prospective, single-center, non-randomized feasibility study of the Bruxoff(TM) device to identify EMG activity associated with bruxism, and to assess the impact of the TMJ NextGeneration(TM) device upon the occurrence of night-time bruxism events and incidence of migraines and headache in subjects diagnosed with sleep bruxism.

Condition or disease Intervention/treatment Phase
Bruxism Device: TMJ NextGeneration(TM) Not Applicable

Detailed Description:
The study will be conducted at one study center in the U.S. Subjects will be enrolled in the trial for a period of 8 weeks. The study will consist of a screening phase lasting up to 2 weeks and a follow up treatment period lasting 8 weeks. Subjects will visit the dental clinic twice during the screening period, then five times during the treatment period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study of the Bruxoff™ Device to Assess EMG Activity in Subjects Diagnosed With Sleep Bruxism Using TMJ NextGeneration(TM)
Study Start Date : November 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : May 2015

Arm Intervention/treatment
Assessing EMG activity with Bruxoff(TM) device
Device: TMJ NextGeneration(TM)
The TMJ NextGeneration(TM) device consists of a pair of small, hollow ear inserts. These ear inserts are custom-fit to each subject's ear canals. The devices rest in the outer third of the ear canal and have a small retraction post that allows for removal of the device from the ear. The devices conform to the shape of the ear canal when the jaw is in the open position and permit full passage of sound into each ear. The mechanisms of action of the inserts are to support the TMJ and associated secondary musculature to reduce strain in the TMJ area and to provide cognitive awareness to the wearer regarding para-functional habits, i.e., jaw clenching.

Primary Outcome Measures :
  1. Effectiveness of Bruxoff(TM) to measure EMG activity in bruxing subjects using the TMJ NextGeneration(TM) device. [ Time Frame: baseline and 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Subjects at least 18 years of age;
  2. Subject has had a diagnosis of sleep bruxism;
  3. Subject has been medically screened and diagnosed by a physician as having headaches and/or migraines;
  4. Subject is willing to comply with the usage instructions for the Bruxoff device;
  5. Is able to read and understand the ICF and has voluntarily provided written informed consent.
  6. Subject is able to open their mouth at least 17 mm to be fitted for the TMJ NextGenerationTM device;
  7. Male Subjects are willing to have a clean shaven face on the nights that the Bruxoff device will be used;
  8. Subject agrees that when using the Bruxoff device to keep their cellular phone in another room.

Exclusion Criteria:

  1. Subjects with any physical or behavioral disorder, which, in the opinion of the Principal Investigator, may interfere with the use of the device or compliance with the study protocol;
  2. Subject has any sleep disorder other than bruxism;
  3. Subjects who have had direct trauma to the jaw;
  4. Subjects who have had prior TMJ or ear surgery;
  5. Subjects who have a narrow ear canal or impression of the ear canal, which is prolapsed due to an anatomical shift or failure of the ear canal wall structure, or a canal that does not allow for the ear canal second turn to be identified;
  6. Subjects with visible or congenital ear deformity as observed on targeted physical exam;
  7. Subjects whose ear canal anatomy does not allow for fit of the study device;
  8. Subjects who have a history of ear pain unrelated to TMJ;
  9. Subjects who have a history of ear drainage in the past 6 months;
  10. Subjects who have active ear drainage, swelling, or redness as observed on targeted physical exam;
  11. Subject has experienced chronic pain (not including migraine pain) associated with sleep bruxism or TMD for more than six months;
  12. Subject has a pacemaker.

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 identifier (NCT number): NCT02257320

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United States, Florida
Ear, Nose and Throat Associates of South Florida
Boca Raton, Florida, United States, 33487
Ear, Nose and Throat Associates of South Florida
Boynton Beach, Florida, United States, 33426
Sponsors and Collaborators
TMJ Health
Cardiox Corporation
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Study Director: simon blackburn Cardiox Corporation

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Responsible Party: TMJ Health Identifier: NCT02257320     History of Changes
Other Study ID Numbers: TMJ-1002
First Posted: October 6, 2014    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Tooth Diseases
Stomatognathic Diseases