NCT02446288

TMJ NextGen Pilot Study to Treat Subjects With Bruxism

A Pilot Study of the TMJ NextGeneration Compared to the DSG Relaxer for Reduction in Nocturnal Bruxism Episodes in Subjects Diagnosed With Sleep Bruxism

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Cardiox Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	TMJ Next Generation
DEVICE	DSG Relaxer

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-10-01
• Completion: 2015-11-01
• First posted: 2015-05-18
• Last updated: 2015-05-18