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

Medotech

Status: Completed

Conditions: Temporomandibular Disorder; Headache

Treatments: Device: Grindcare® (Biofeedback)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01000389

TMD-02

Details and patient eligibility

About

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

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)