BruxismBruxoffNCT02257320

TMJ NextGeneration(TM) Feasibility Study

A study testing TMJ NextGeneration(TM) in people with Bruxism, run by TMJ Health at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Bruxism
What is being tested?: TMJ NextGeneration(TM)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 2 sitesUnited States
Study dates: Nov 2014to May 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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 any sleep disorder other than bruxism;
Subjects who have had direct trauma to the jaw;
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;

Show all 12Show fewer

Subjects whose ear canal anatomy does not allow for fit of the study device;
Subjects who have a history of ear pain unrelated to TMJ;
Subjects who have a history of ear drainage in the past 6 months;
Subjects who have active ear drainage, swelling, or redness as observed on targeted physical exam;
Subject has experienced chronic pain (not including migraine pain) associated with sleep bruxism or TMD for more than six months;
Subject has a pacemaker.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Ear, Nose and Throat Associates of South Florida
Boca Raton, Florida, 33487
Ear, Nose and Throat Associates of South Florida
Boynton Beach, Florida, 33426

Other trials in United States

About this study

Official title: A Feasibility Study of the Bruxoff™ Device to Assess EMG Activity in Subjects Diagnosed With Sleep Bruxism Using TMJ NextGeneration(TM)

Read the 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.

Conditions: Bruxism
Being tested: TMJ NextGeneration(TM)
Medical subject headings: Bruxism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TMJ NextGeneration(TM)Device
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.

Study groups in NCT02257320
Study group	Role	What they receive
Feasibility	Other	Assessing EMG activity with Bruxoff(TM) device Receives: Device: TMJ NextGeneration(TM)

What is being measured

The primary outcome is the main question the study is designed to answer.

Effectiveness of Bruxoff(TM) to measure EMG activity in bruxing subjects using the TMJ NextGeneration(TM) device.
Measured: baseline and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014May 2015

First posted6 Oct 2014 (estimated)
Study startNov 2014
Primary completionFeb 2015
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for BruxismStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02257320
Sponsor's protocol ID: TMJ-1002
Acronym: Bruxoff
Status last verified: Jun 2015
First submitted: 2 Oct 2014
Last updated: 10 Jun 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bruxism trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Feasibility Study of the Bruxoff™ Device to Assess EMG Activity in Subjects Diagnosed With Sleep Bruxism Using TMJ NextGeneration(TM)
ClinicalTrials.gov ID: NCT02257320
Acronym / sponsor ID: Bruxoff / TMJ-1002
Conditions: Bruxism
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: TMJ HealthIndustry (pharma, biotech, devices)
Collaborators: Cardiox Corporation
Study start: Nov 2014
Primary completion: Feb 2015 (actual)
Study completion: May 2015 (actual)
First posted: 6 Oct 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Feasibility	Other	Device: TMJ NextGeneration(TM)Assessing EMG activity with Bruxoff(TM) device

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Subjects at least 18 years of age;
Subject has had a diagnosis of sleep bruxism;
Subject has been medically screened and diagnosed by a physician as having headaches and/or migraines;
Subject is willing to comply with the usage instructions for the Bruxoff device;
Is able to read and understand the ICF and has voluntarily provided written informed consent.

Key exclusion criteria (12 listed)

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 any sleep disorder other than bruxism;
Subjects who have had direct trauma to the jaw;
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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	Feasibility

Primary outcome

Effectiveness of Bruxoff(TM) to measure EMG activity in bruxing subjects using the TMJ NextGeneration(TM) device.
Time frame: baseline and 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.

Related trials for Bruxism

RecruitingObservational study
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Enrolling by invitationObservational study
The General Aim is to Implement Clinical Assessment of Overload by Voluntary Bite Force Registration to Enable Future Simple But Precise Risk Assessment to Provide Individualized Treatment Plans.
Dental Implant, Bruxism
RecruitingObservational study
Effect Of Orofacial Pain Therapy On Bruxism
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Not yet recruiting
Influence Of Different Relaxation Techniques On Stress Level For Patients With Bruxism Using Salivary Biomarkers.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

simon blackburn study director

Cardiox Corporation

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing TMJ NextGeneration(TM) in people with Bruxism, run by TMJ Health at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness of Bruxoff(TM) to measure EMG activity in bruxing subjects using the TMJ NextGeneration(TM) device. (time frame: baseline and 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02257320.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2015.