NCT02269553

TMJ-1001 Bruxism Run-In/Pivotal Trial

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: TMJ Health · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Bruxism

Interventions

Type	Name	Description
DEVICE	TMJ(TM) NextGeneration	The TMJ NextGeneration(TM) device consists of a pair of small, hollow ear inserts.
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.

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-10-21
• Last updated: 2015-05-14