TMJ NextGen Pilot Study to Treat Subjects With Bruxism

Bruxism Clinical Trial

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

Status Not yet recruiting

Clinical 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.

Clinical Trial 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bruxism

• NCT number: NCT02446288
• Study type: Interventional
• Source: Cardiox Corporation
• Contact: Simon Blackburn, CCRA
• Phone: 614.323.7034
• Email: simonblackburn@cardiox.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2015
• Completion date: November 2015