BruxismNCT02269553

TMJ-1001 Bruxism Run-In/Pivotal Trial

A study testing TMJ(TM) NextGeneration and Standard Hard TMJD Splint in people with Bruxism, run by TMJ Health.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

The study is an open-label, prospective, multi-center, randomized, two treatment parallel, comparison study of the TMJ NextGeneration(TM) and custom-fit occlusal splint in the reduction of nocturnal bruxism episodes and monthly migraine episodes in subjects diagnosed with sleep bruxism and headaches. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bruxism
What is being tested?: TMJ(TM) NextGeneration and Standard Hard TMJD Splint
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: Apr 2015to Dec 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
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is at least 18 years of age;
Subject has had a diagnosis of sleep bruxism within the past 30 days;
Subject is able to read and understand the ICF and has voluntarily provided written informed consent;
Subject must have a minimum of 26 remaining teeth;
Subject has recorded more than 50% of screening period diary pain VAS scores ≥40;
Subject has been medically screened and diagnosed by a physician as having migraines;

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Subject has been prescribed and is using a triptan as a rescue medication for their migraine episodes;
Subject has recorded ≥ 2 self-diagnosed migraine episodes in the screening diary;
Subject has an average of ≥ 4 bruxism episodes per hour of sleep based on the screening sleep EMG evaluations;
Subject is willing to comply with the usage instructions for the Bruxoff (sleep EMG evaluation) device.
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;
Subject experiences chronic migraines, > 15 per month;
Subject experiences secondary headaches (i.e. Arnold-Chiari syndrome and/or low pressure headaches) in the opinion of the Investigator;
Subjects who have used an occlusal appliance to treat TMD within the previous six months;

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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 -7 of the study;
Subjects who have a history of 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);
Subjects who, in the opinion of the investigator, cannot be properly fit with their assigned device;
Subject has experienced chronic pain (not including migraine pain) associated with sleep bruxism or TMD for more than six months;
Subject has a pacemaker.
Subject has an allergy to polyethylene, dicumyl peroxide, azodicarbonamide, or ammonia.

About this study

Official title: A Pivotal Study of the TMJ NextGeneration(TradeMark) Compared to Occlusal Splint Treatment for Reduction in Nocturnal Bruxism Episodes and Monthly Migraine Episodes in Subjects Diagnosed With Sleep Bruxism

Read the detailed description

The study will be conducted at multiple study centers in the U.S. The study will consist of a screening period lasting up to 5 weeks and a treatment period lasting 8 weeks. Subjects will visit the dental clinic twice during the screening period, at Day 1, and at Weeks 4 and 8 of the study.The study will include a single-center run-in phase during which 12 subjects will be enrolled in order to gain preliminary effectiveness data on the TMJ NextGeneration(TM) device. Following completion of the first 12 subjects, a sample size re-estimation may be conducted in order to verify the initial sample size assumptions of the study. These run-in subjects will not be included in the final analysis of the study. Approximately a total of 153 subjects will be enrolled in the study with subjects allocated 2:1 to the TMJ NextGeneration(TM) and occlusal splint treatment arms, respectively. The study is powered with respect to the dual primary effectiveness endpoints of CFB in bruxism episodes per hour of sleep and CFB in migraine episodes per month.

Conditions: Bruxism
Being tested: TMJ(TM) NextGeneration, Standard Hard TMJD Splint
Keywords: Migraine, Headache
Medical subject headings: Bruxism, Migraine Disorders, Headache

What participants receive

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

TMJ(TM) NextGenerationDevice
The TMJ NextGeneration(TM) device consists of a pair of small, hollow ear inserts.
Standard Hard TMJD SplintDevice
The occlusal splint to be used in this study will be a hard, full-arch splint with at least one occlusal contact on each tooth of the opposing arch.

Study groups in NCT02269553
Study group	Role	What they receive
TMJ NextGeneration(TM)	Active comparator	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. 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 device is FDA cleared under a 510(k) with an indication of reducing TMD pain. Receives: Device: TMJ(TM) NextGeneration
Standard Hard TMJD Splint	Active comparator	The occlusal splint to be used in this study will be a hard, full-arch splint with at least one occlusal contact on each tooth of the opposing arch. Each patient assigned to the occlusal splint treatment group may wear either maxillary or mandibular splints or both, as prescribed by the subject's dentist, during the study. All occlusal splints used in the study will be custom fit to each patient using standard dental processes. All occlusal splints used in the study will be manufactured by Paul O'Neill Dental Lab, Yucaipa , CA, USA using clear ADA approved orthodontic acrylic Receives: Device: Standard Hard TMJD Splint

What is being measured

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

Change from Baseline (CFB) in bruxism episodes per hour of sleep
Measured: Baseline and Week 8
CFB in the number of migraine episodes per month
Measured: Baseline and Week 8

Secondary outcomes (5)

CFB in the number of headache episodes per month
Measured: Baseline and Week 8
CFB in the in-clinic pain Visual Analogue Scale (VAS) scores
Measured: Baseline and Week 8
CFB in the average daily at-home pain VAS scores
Measured: Baseline and Week 8
CFB in the morning daily at-home pain VAS scores
Measured: Baseline and Week 8
CFB in the evening daily at-home pain VAS scores
Measured: Baseline and Week 8

Timeline

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

Apr 2015Dec 2015

First posted21 Oct 2014 (estimated)
Study startApr 2015
Primary completionDec 2015 (estimated)
Study completionDec 2015 (estimated)

Why it stopped: Study redesigned into three separate trials.

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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02269553
Sponsor's protocol ID: TMJ-1001
Status last verified: May 2015
First submitted: 7 Oct 2014
Last updated: 14 May 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?

Official record

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All Bruxism trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pivotal Study of the TMJ NextGeneration(TradeMark) Compared to Occlusal Splint Treatment for Reduction in Nocturnal Bruxism Episodes and Monthly Migraine Episodes in Subjects Diagnosed With Sleep Bruxism
ClinicalTrials.gov ID: NCT02269553
Acronym / sponsor ID: TMJ-1001
Conditions: Bruxism
Keywords: Migraine, Headache
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Study redesigned into three separate trials.
Enrolment: 0 participants (actual)
Lead sponsor: TMJ HealthIndustry (pharma, biotech, devices)
Collaborators: Cardiox Corporation
Study start: Apr 2015
Primary completion: Dec 2015 (estimated)
Study completion: Dec 2015 (estimated)
First posted: 21 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
TMJ NextGeneration(TM)	Active comparator	Device: TMJ(TM) NextGenerationThe 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. 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 device is FDA cleared under a 510(k) with an indication of reducing TMD pain.
Standard Hard TMJD Splint	Active comparator	Device: Standard Hard TMJD SplintThe occlusal splint to be used in this study will be a hard, full-arch splint with at least one occlusal contact on each tooth of the opposing arch. Each patient assigned to the occlusal splint treatment group may wear either maxillary or mandibular splints or both, as prescribed by the subject's dentist, during the study. All occlusal splints used in the study will be custom fit to each patient using standard dental processes. All occlusal splints used in the study will be manufactured by Paul O'Neill Dental Lab, Yucaipa , CA, USA using clear ADA approved orthodontic acrylic

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Subject is at least 18 years of age;
Subject has had a diagnosis of sleep bruxism within the past 30 days;
Subject is able to read and understand the ICF and has voluntarily provided written informed consent;
Subject must have a minimum of 26 remaining teeth;
Subject has recorded more than 50% of screening period diary pain VAS scores ≥40;

Key exclusion criteria (18 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;
Subject experiences chronic migraines, > 15 per month;
Subject experiences secondary headaches (i.e. Arnold-Chiari syndrome and/or low pressure headaches) in the opinion of the Investigator;

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(TM) NextGenerationThe TMJ NextGeneration(TM) device consists of a pair of small, hollow ear inserts.	Device	TMJ NextGeneration(TM)
Standard Hard TMJD SplintThe occlusal splint to be used in this study will be a hard, full-arch splint with at least one occlusal contact on each tooth of the opposing arch.	Device	Standard Hard TMJD Splint

Primary outcome

Change from Baseline (CFB) in bruxism episodes per hour of sleep
Time frame: Baseline and Week 8
CFB in the number of migraine episodes per month
Time frame: Baseline and Week 8

5 secondary outcomes

CFB in the number of headache episodes per month
Time frame: Baseline and Week 8
CFB in the in-clinic pain Visual Analogue Scale (VAS) scores
Time frame: Baseline and Week 8
CFB in the average daily at-home pain VAS scores
Time frame: Baseline and Week 8
CFB in the morning daily at-home pain VAS scores
Time frame: Baseline and Week 8
CFB in the evening daily at-home pain VAS scores
Time frame: Baseline and Week 8

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2015.

Related trials for Bruxism

RecruitingObservational study
Bruxism, Anxiety, and Periodontal Status Among Dental Students
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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.
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RecruitingObservational study
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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, CCRA study director

Senior Director, Clinical Affairs

Questions about this trial

What is this clinical trial studying?

A study testing TMJ(TM) NextGeneration and Standard Hard TMJD Splint in people with Bruxism, run by TMJ Health.

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 13 inclusion and 18 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: withdrawn, as of the sponsor's last update on 14 May 2015. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Change from Baseline (CFB) in bruxism episodes per hour of sleep (time frame: Baseline and Week 8). The study lists 2 primary outcomes in all. 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 NCT02269553.

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 14 May 2015.