- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02257320
TMJ NextGeneration(TM) Feasibility Study (Bruxoff)
June 8, 2015 updated by: TMJ Health
A Feasibility Study of the Bruxoff™ Device to Assess EMG Activity in Subjects Diagnosed With Sleep Bruxism Using TMJ NextGeneration(TM)
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 subjects diagnosed with sleep bruxism.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Boca Raton, Florida, United States, 33487
- Ear, Nose and Throat Associates of South Florida
-
Boynton Beach, Florida, United States, 33426
- Ear, Nose and Throat Associates of South Florida
-
-
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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
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 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;
- 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.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Feasibility
Assessing EMG activity with Bruxoff(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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effectiveness of Bruxoff(TM) to measure EMG activity in bruxing subjects using the TMJ NextGeneration(TM) device.
Time Frame: baseline and 8 weeks
|
baseline and 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: simon blackburn, Cardiox Corporation
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
November 1, 2014
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
October 2, 2014
First Submitted That Met QC Criteria
October 2, 2014
First Posted (Estimate)
October 6, 2014
Study Record Updates
Last Update Posted (Estimate)
June 10, 2015
Last Update Submitted That Met QC Criteria
June 8, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMJ-1002
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.
Clinical Trials on Bruxism
-
Karabuk UniversityRecruiting
-
Riyadh Colleges of Dentistry and PharmacyUnknownNocturnal BruxismSaudi Arabia
-
Damascus UniversityCompletedNocturnal BruxismSyrian Arab Republic
-
University of California, San FranciscoWithdrawn
-
University of Nove de JulhoUnknown
-
Universidade Federal do Rio de JaneiroUnknown
-
CES UniversityNot yet recruitingSleep Bruxism, Childhood
-
Aydin Adnan Menderes UniversityCompleted
-
Dominik EttlinMerz PharmaceuticalsNot yet recruiting
-
Federal University of PelotasUnknown
Clinical Trials on TMJ NextGeneration(TM)
-
Sohag UniversityNot yet recruitingTemporomandibular Joint Disc Displacement, Without ReductionEgypt
-
Erzincan UniversityCompleted
-
Mohamed Gamal ThabetRecruiting
-
Sun Yat-sen UniversityRecruiting
-
Uskudar UniversityCompletedChronic Pain | Neck Pain | Temporomandibular Joint Disorders | Temporomandibular Joint Dysfunction SyndromeTurkey
-
Alexandria UniversityCompleted
-
Fonseca, JulioUnknownTMJ Disc Disorder | TMJ Pain | TMJ Sounds on Opening/Closing the Jaw | TMJ - Injury of Meniscus of Temporomandibular JointPortugal
-
Sohag UniversityNot yet recruiting
-
Future University in EgyptCompletedTemporomandibular Joint Disc DisplacementEgypt