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

A Single Centre, Randomised, Clinical Placebo Controlled Study of the Optimal Treatment and Long-term Effect of FES on Bruxism

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00807430

Enrollment

Registered

2008-12-11

Start date

2009-02-28

Completion date

2009-10-31

Last updated

2009-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bruxism

Keywords

Bruxism, EMG, Biofeedback

Brief summary

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

Interventions

DEVICEGrindcare (Active)

Active treatment

DEVICEGrindcare (Placebo - the device is not activated)

Placebo treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Primary outcome is to reduce the EMG activity per hour per night	10 weeks after start of treatment

Secondary

Measure	Time frame
Secondary outcome is to evaluate long-term effect of FES om EMG activity	after end of treatment with FES

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026