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

Medotech

Status: Terminated

Conditions: Bruxism

Treatments: Device: Grindcare (Active); Device: Grindcare (Placebo - the device is not activated)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00807430

TMD-00

Details and patient eligibility

About

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

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

48 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

24 patients receiving active treatment

Treatment:

Device: Grindcare (Active)

2

Placebo Comparator group

Description:

Placebo treatment

Treatment:

Device: Grindcare (Placebo - the device is not activated)