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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01000389

Enrollment

Registered

2009-10-23

Start date

2009-10-31

Completion date

2011-03-31

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

Headache, Temporomandibular Disorder

Brief summary

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

Interventions

DEVICEGrindcare® (Biofeedback)

Active treatment with functional electrical stimulation

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Reduction of number of grinds per hour per night	7 weeks

Countries

Denmark

Outcome results

None listed

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