A Clinical Trial of the Optimal Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep Bruxism

To investigate the effect of the treatment with Grindcare® on the parafunction of the muscles- and jaw activity (Bruxism) during sleep.

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Key information

Conditions

Temporomandibular Disorder Craniomandibular Disorders Headache Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odontologisk Institute

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

RDC-TMD diagnosis
Verified sleep bruxism
More than 18 Years
Signed ICF

Exclusion criteria

Contraindication of concomitant medication and diseases judged by investigator
Pacemaker

Treatment and study plan

Grindcare® (Biofeedback)

Device

Active treatment with functional electrical stimulation

Primary outcomes

Reduction of number of grinds per hour per night

Time frame: 7 weeks

Sponsors and collaborators

Lead sponsor

Medotech A/S

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Oct 23, 2009
Registry last updated: Jun 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed