Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep 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

GrindcareDEVICE

Active treatment

Grindcare - inactiveDEVICE

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) Exclusion Criteria: * Contraindication of concommitant diseases for the study judged by investigator * Patients who are using occlusal splints in the treatment period.

Locations (1)

Odontologisk Institute

Aarhus, Denmark

Outcomes

Primary Outcomes

Reduction in the electromyography (EMG) activity per hour per night

Time frame: 10 weeks after start of treatment

Secondary Outcomes

Evaluation of long-term effect of FES on the EMG activity

Time frame: a 4 weeks period after end og treatment with FES

Data from ClinicalTrials.gov

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