TMJ-1001 Bruxism Run-In/Pivotal Trial

May 12, 2015 updated by: TMJ Health

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is at least 18 years of age;
  2. Subject has had a diagnosis of sleep bruxism within the past 30 days;
  3. Subject is able to read and understand the ICF and has voluntarily provided written informed consent;
  4. Subject must have a minimum of 26 remaining teeth;
  5. Subject has recorded more than 50% of screening period diary pain VAS scores ≥40;
  6. Subject has been medically screened and diagnosed by a physician as having migraines;
  7. Subject has been prescribed and is using a triptan as a rescue medication for their migraine episodes;
  8. Subject has recorded ≥ 2 self-diagnosed migraine episodes in the screening diary;
  9. Subject has an average of ≥ 4 bruxism episodes per hour of sleep based on the screening sleep EMG evaluations;
  10. Subject is willing to comply with the usage instructions for the Bruxoff (sleep EMG evaluation) device.
  11. Subject is able to open their mouth at least 17 mm to be fitted for the TMJ NextGenerationTM device.
  12. Male Subjects are willing to have a clean shaven face on the nights that the Bruxoff device will be used;
  13. 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. Subject experiences chronic migraines, > 15 per month;
  5. Subject experiences secondary headaches (i.e. Arnold-Chiari syndrome and/or low pressure headaches) in the opinion of the Investigator;
  6. Subjects who have used an occlusal appliance to treat TMD within the previous six months;
  7. Subjects who have had prior TMJ or ear surgery;
  8. 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;
  9. Subjects with visible or congenital ear deformity as observed on targeted physical exam that does not allow for fitting of the study device;
  10. Subjects who have taken a narcotic pain medication in the last seven days prior to Day -7 of the study;
  11. Subjects who have a history of ear pain unrelated to TMJ;
  12. Subjects who have a history of ear drainage in the past six months;
  13. Subjects who have active ear drainage, swelling, or redness as observed on targeted physical exam;
  14. 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);
  15. Subjects who, in the opinion of the investigator, cannot be properly fit with their assigned device;
  16. Subject has experienced chronic pain (not including migraine pain) associated with sleep bruxism or TMD for more than six months;
  17. Subject has a pacemaker.
  18. Subject has an allergy to polyethylene, dicumyl peroxide, azodicarbonamide, or ammonia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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. 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.
Device: TMJ(TM) NextGeneration
The TMJ NextGeneration(TM) device consists of a pair of small, hollow ear inserts.
Active Comparator: Standard Hard TMJD Splint
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
Device: Standard Hard TMJD Splint
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from Baseline (CFB) in bruxism episodes per hour of sleep
Time Frame: Baseline and Week 8
Baseline and Week 8
CFB in the number of migraine episodes per month
Time Frame: Baseline and Week 8
Baseline and Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
CFB in the number of headache episodes per month
Time Frame: Baseline and Week 8
Baseline and Week 8
CFB in the in-clinic pain Visual Analogue Scale (VAS) scores
Time Frame: Baseline and Week 8
Baseline and Week 8
CFB in the average daily at-home pain VAS scores
Time Frame: Baseline and Week 8
Baseline and Week 8
CFB in the morning daily at-home pain VAS scores
Time Frame: Baseline and Week 8
Baseline and Week 8
CFB in the evening daily at-home pain VAS scores
Time Frame: Baseline and Week 8
Baseline and Week 8

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: Baseline and Week 8
Baseline and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TMJ Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cardiox Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: simon blackburn, CCRA, Senior Director, Clinical Affairs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TMJ-1001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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