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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00807430
Recruitment Status : Terminated
First Posted : December 11, 2008
Last Update Posted : October 21, 2009
Information provided by:
Medotech A/S

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

Condition or disease Intervention/treatment Phase
Bruxism Device: Grindcare (Active) Device: Grindcare (Placebo - the device is not activated) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
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
Study Start Date : February 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : October 2009

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00807430

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

Responsible Party: Peter Svensson, Aarhus University Dentist School Identifier: NCT00807430     History of Changes
Other Study ID Numbers: TMD-00
First Posted: December 11, 2008    Key Record Dates
Last Update Posted: October 21, 2009
Last Verified: October 2009

Keywords provided by Medotech A/S:

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases