BruxismNCT02446288
TMJ NextGen Pilot Study to Treat Subjects With Bruxism
A study testing TMJ Next Generation and DSG Relaxer in people with Bruxism, run by Cardiox Corporation.
Trial 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. 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 Next Generation and DSG Relaxer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Nov 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
- 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.
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 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;
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- 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).
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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).
- Conditions
- Bruxism
- Being tested
- TMJ Next Generation, DSG Relaxer
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMJ Next GenerationDevice
DSG RelaxerDevice
| Study group | Role | What they receive |
|---|---|---|
| TMJ Next Generation | Active comparator | 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. Receives: Device: TMJ Next Generation |
| DSG Relaxer | Active comparator | 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. Receives: Device: DSG Relaxer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (1)
The secondary objective of this study is to further establish the safety of the TMJ NextGeneration device as determined by adverse events.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2015 (estimated)
- Study completionNov 2015 (estimated)
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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiox Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TMJ Health
- Responsible party
- Sponsor
- Investigators
- Simon Blackburn, CCRA, Study director, Cardiox Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02446288
- Sponsor's protocol ID
- TMJ-1003
- Status last verified
- May 2015
- First submitted
- 12 May 2015
- Last updated
- 18 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02446288
- Acronym / sponsor ID
- TMJ-1003
- Conditions
- Bruxism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cardiox CorporationIndustry (pharma, biotech, devices)
- Collaborators
- TMJ Health
- Study start
- Jun 2015
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 18 May 2015 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMJ Next Generation | Active comparator | Device: TMJ Next GenerationThe 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. |
| DSG Relaxer | Active comparator | Device: DSG RelaxerThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (16 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 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;
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 Next Generation | Device | TMJ Next Generation |
| DSG Relaxer | Device | DSG Relaxer |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2015.
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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
Cardiox Corporation
Questions about this trial
What is this clinical trial studying?
A study testing TMJ Next Generation and DSG Relaxer in people with Bruxism, run by Cardiox Corporation.
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 6 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 18 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simon Blackburn, CCRA (614.323.7034, simonblackburn@cardiox.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2015.