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

Bruxism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00807430
• Other study ID #: TMD-00
• Status: Terminated
• Phase: N/A
• First received: December 9, 2008
• Last updated: October 20, 2009
• Start date: February 2009
• Est. completion date: October 2009

Study information

• Verified date: October 2009
• Source: Medotech A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: October 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bruxism

Intervention

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

Locations

Country	Name	City	State
Denmark	Odontologisk Institut	Aarhus C

Sponsors (1)

Lead Sponsor	Collaborator
Medotech A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome is to reduce the EMG activity per hour per night		10 weeks after start of treatment	No
Secondary	Secondary outcome is to evaluate long-term effect of FES om EMG activity		after end of treatment with FES	No