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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01005511

Enrollment

Registered

2009-11-02

Start date

2009-10-31

Completion date

2010-12-31

Last updated

2011-06-08

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

Conditions

Bruxism

Keywords

Bruxism

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 treatment

DEVICEGrindcare - inactive

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)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Reduction in the electromyography (EMG) activity per hour per night	10 weeks after start of treatment

Secondary

Measure	Time frame
Evaluation of long-term effect of FES on the EMG activity	a 4 weeks period after end og treatment with FES

Countries

Denmark

Outcome results

None listed

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