This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been terminated.
Information provided by:
Medotech A/S Identifier:
First received: December 9, 2008
Last updated: October 20, 2009
Last verified: October 2009
To investigate the effect of the treatment with Grindcare® on the muscles- and jaw symptoms and at the jaw muscle activity during sleep.

Condition Intervention
Bruxism Device: Grindcare (Active) Device: Grindcare (Placebo - the device is not activated)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single Centre, Randomised, Clinical Placebo Controlled Study of the Optimal Treatment and Long-term Effect of FES on Bruxism

Further study details as provided by Medotech A/S:

Primary Outcome Measures:
  • Primary outcome is to reduce the EMG activity per hour per night [ Time Frame: 10 weeks after start of treatment ]

Secondary Outcome Measures:
  • Secondary outcome is to evaluate long-term effect of FES om EMG activity [ Time Frame: after end of treatment with FES ]

Estimated Enrollment: 48
Study Start Date: February 2009
Study Completion Date: October 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
24 patients receiving active treatment
Device: Grindcare (Active)
Active treatment
Placebo Comparator: 2
Placebo treatment
Device: Grindcare (Placebo - the device is not activated)
Placebo treatment


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00807430

Odontologisk Institut
Aarhus C, Denmark, 8000
Sponsors and Collaborators
Medotech A/S
Study Director: Troels B Mortensen Medotech A/S
  More Information

Responsible Party: Peter Svensson, Aarhus University Dentist School Identifier: NCT00807430     History of Changes
Other Study ID Numbers: TMD-00
Study First Received: December 9, 2008
Last Updated: October 20, 2009

Keywords provided by Medotech A/S:

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases processed this record on September 21, 2017