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TMJ-1001 Bruxism Run-In/Pivotal Trial

NCT02269553 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-05-14

No results posted yet for this study

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.

Conditions

  • Bruxism

Interventions

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.

Sponsors & Collaborators

  • Cardiox Corporation

    collaborator INDUSTRY

  • TMJ Health

    lead INDUSTRY

Principal Investigators

  • simon blackburn, CCRA · Senior Director, Clinical Affairs

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-12-31
Completion
2015-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02269553 on ClinicalTrials.gov