TMJ NextGen Pilot Study to Treat Subjects With Bruxism
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|ClinicalTrials.gov Identifier: NCT02446288|
Recruitment Status : Unknown
Verified May 2015 by Cardiox Corporation.
Recruitment status was: Not yet recruiting
First Posted : May 18, 2015
Last Update Posted : May 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Bruxism||Device: TMJ Next Generation Device: DSG Relaxer||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||November 2015|
Active Comparator: TMJ Next Generation
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.
Device: TMJ Next Generation
Active Comparator: DSG Relaxer
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.
Device: DSG Relaxer
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02446288
|Contact: Simon Blackburn, CCRAfirstname.lastname@example.org|
|Study Director:||Simon Blackburn, CCRA||Cardiox Corporation|