Treatment Period and Long-term Effect of Functional Electric Stimulation (FES) for Bruxism

Medotech A/S48 enrolled

Overview

To investigate the effect of the treatment with Grindcare® on the muscles- and jaw symptoms and at the jaw muscle activity during sleep.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Bruxism

Interventions

Grindcare (Active)DEVICE

Active treatment

Grindcare (Placebo - the device is not activated)DEVICE

Placebo treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed and dated ICF * 18 years or older * Fulfill the RDC-criteria for myofascial TMD diagnose (group 1a or 1b) * Average pain more that 3 on a Visual Analog scale (VAS) in the baseline period Exclusion Criteria: * Contraindication of concommitant diseases for the study judged by investigator * Daily use of pain medication, e.g. prophylaxis against migraine or headache. * Patients who are using occlusal splints in the treatment period.

Locations (1)

Odontologisk Institut

Aarhus C, Denmark

Outcomes

Primary Outcomes

Primary outcome is to reduce the EMG activity per hour per night

Time frame: 10 weeks after start of treatment

Secondary Outcomes

Secondary outcome is to evaluate long-term effect of FES om EMG activity

Time frame: after end of treatment with FES

Data from ClinicalTrials.gov

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