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

Medotech

Status: Terminated

Conditions: Bruxism

Treatments: Device: Grindcare - inactive; Device: Grindcare

Study type: Interventional

Funder types: Industry

Identifiers

NCT01005511

TMD-01

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)

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

Grindcare

Experimental group

Description:

24 patients receiving active treatment

Treatment:

Device: Grindcare

Placebo treatment

Placebo Comparator group

Description:

24 patients receive a placebo treatment

Treatment:

Device: Grindcare - inactive