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TMJ NextGen Pilot Study to Treat Subjects With Bruxism

Primary Purpose

Bruxism

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TMJ Next Generation
DSG Relaxer
Sponsored by
Cardiox Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bruxism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects at least 18 years of age;
  2. Subject has had a diagnosis of sleep bruxism confirmed within the past 30 days;
  3. Subject has an average of ≥ 1.25 bruxism episodes per hour of sleep based on two nights of screening Bruxoff™ evaluations;
  4. Subject is able to read and understand the ICF and has voluntarily provided written informed consent;
  5. Subject has a minimum of 26 remaining teeth;
  6. Subject has an average of ≥ 1.25 bruxism episodes per hour of sleep based on the single-night screening sleep PSG evaluations.

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 a significant respiratory disease that actively requires treatment;
  3. Subject is taking antidepressant medication;
  4. Subject has a significant sleep disorder that actively requires treatment, in addition to bruxism;
  5. Subject is undergoing treatment for sleep apnea;
  6. Subjects diagnosed with rheumatoid arthritis, osteoarthritis, osteoarthrosis, or another connective tissue disorder of the head/neck region;
  7. Subjects who have had direct trauma to the jaw;
  8. Subjects who have used an occlusal appliance to treat a TMD within the previous six months;
  9. Subjects who have had prior TMJ or ear surgery;
  10. 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;
  11. Subjects with visible or congenital ear deformity as observed on targeted physical exam that does not allow for fitting of the study device;
  12. Subjects who have taken a narcotic pain medication in the last seven days prior to Day 1 of the study;
  13. Subjects who have a history of chronic ear pain unrelated to TMJ;
  14. Subjects who have a history of ear drainage in the past six months;
  15. Subjects who have active ear drainage, swelling, or redness as observed on targeted physical exam;
  16. Subjects whom the investigator believes may not be an appropriate candidate for an intra-oral splint due to missing or poor quality dentition or untreated pain of dental origin (pulpal pain, pericoronitis of wisdom teeth, or similar conditions).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    TMJ Next Generation

    DSG Relaxer

    Arm Description

    The TMJ NextGeneration device consists of a pair of small, hollow ear inserts. These ear inserts are custom-fit to each subject's ear canals. They are constructed from methacrylate polymers - the same material as has been used in hearing aids. 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 individuals' ear canals when the jaw is in the open position and permit full passage of sound into each ear. The proposed 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.

    The occlusal splint to be used in this study will be the DSG Relaxer™. The DSG Relaxer™ is a device that has been FDA cleared for the treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches and relieving bruxism and TMJ syndrome through the reduction of trigeminally innervated muscular therapy.

    Outcomes

    Primary Outcome Measures

    The primary objective of this study is to determine the effectiveness of the TMJ NextGeneration to reduce nocturnal bruxism episodes in subjects experiencing sleep bruxism as determined by polysomnography.

    Secondary Outcome Measures

    The secondary objective of this study is to further establish the safety of the TMJ NextGeneration device as determined by adverse events.

    Full Information

    First Posted
    May 12, 2015
    Last Updated
    May 13, 2015
    Sponsor
    Cardiox Corporation
    Collaborators
    TMJ Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02446288
    Brief Title
    TMJ NextGen Pilot Study to Treat Subjects With Bruxism
    Official Title
    A Pilot Study of the TMJ NextGeneration Compared to the DSG Relaxer for Reduction in Nocturnal Bruxism Episodes in Subjects Diagnosed With Sleep Bruxism
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2015 (undefined)
    Primary Completion Date
    October 2015 (Anticipated)
    Study Completion Date
    November 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cardiox Corporation
    Collaborators
    TMJ Health

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study is an open-label, prospective, multicenter, randomized, two treatment parallel, comparison study of the TMJ NextGeneration and DSG Relaxer in the reduction of nocturnal bruxism episodes in subjects diagnosed with sleep bruxism.
    Detailed Description
    The study will be conducted at multiple study centers in the U.S. Subjects will be enrolled in the trial for a period of 44 days. The study will consist of a screening period lasting up to 30 days, a device fitting period of 14 days, and a treatment period lasting 30 days. Subjects will visit the clinic three times during the screening period, followed by visits at Day 1, Day 14, and Day 44 of the study. Subjects will visit the sleep center once during the screening period (Day -1) and once during the treatment period (Day 43).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bruxism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TMJ Next Generation
    Arm Type
    Active Comparator
    Arm Description
    The TMJ NextGeneration device consists of a pair of small, hollow ear inserts. These ear inserts are custom-fit to each subject's ear canals. They are constructed from methacrylate polymers - the same material as has been used in hearing aids. 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 individuals' ear canals when the jaw is in the open position and permit full passage of sound into each ear. The proposed 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.
    Arm Title
    DSG Relaxer
    Arm Type
    Active Comparator
    Arm Description
    The occlusal splint to be used in this study will be the DSG Relaxer™. The DSG Relaxer™ is a device that has been FDA cleared for the treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches and relieving bruxism and TMJ syndrome through the reduction of trigeminally innervated muscular therapy.
    Intervention Type
    Device
    Intervention Name(s)
    TMJ Next Generation
    Intervention Type
    Device
    Intervention Name(s)
    DSG Relaxer
    Primary Outcome Measure Information:
    Title
    The primary objective of this study is to determine the effectiveness of the TMJ NextGeneration to reduce nocturnal bruxism episodes in subjects experiencing sleep bruxism as determined by polysomnography.
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    The secondary objective of this study is to further establish the safety of the TMJ NextGeneration device as determined by adverse events.
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects at least 18 years of age; Subject has had a diagnosis of sleep bruxism confirmed within the past 30 days; Subject has an average of ≥ 1.25 bruxism episodes per hour of sleep based on two nights of screening Bruxoff™ evaluations; Subject is able to read and understand the ICF and has voluntarily provided written informed consent; Subject has a minimum of 26 remaining teeth; Subject has an average of ≥ 1.25 bruxism episodes per hour of sleep based on the single-night screening sleep PSG evaluations. Exclusion Criteria: 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; Subject has a significant respiratory disease that actively requires treatment; Subject is taking antidepressant medication; Subject has a significant sleep disorder that actively requires treatment, in addition to bruxism; Subject is undergoing treatment for sleep apnea; Subjects diagnosed with rheumatoid arthritis, osteoarthritis, osteoarthrosis, or another connective tissue disorder of the head/neck region; Subjects who have had direct trauma to the jaw; Subjects who have used an occlusal appliance to treat a TMD within the previous six months; Subjects who have had prior TMJ or ear surgery; 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; Subjects with visible or congenital ear deformity as observed on targeted physical exam that does not allow for fitting of the study device; Subjects who have taken a narcotic pain medication in the last seven days prior to Day 1 of the study; Subjects who have a history of chronic ear pain unrelated to TMJ; Subjects who have a history of ear drainage in the past six months; Subjects who have active ear drainage, swelling, or redness as observed on targeted physical exam; Subjects whom the investigator believes may not be an appropriate candidate for an intra-oral splint due to missing or poor quality dentition or untreated pain of dental origin (pulpal pain, pericoronitis of wisdom teeth, or similar conditions).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Simon Blackburn, CCRA
    Phone
    614.323.7034
    Email
    simonblackburn@cardiox.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Simon Blackburn, CCRA
    Organizational Affiliation
    Cardiox Corporation
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    TMJ NextGen Pilot Study to Treat Subjects With Bruxism

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