COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep 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: NCT01005511
Recruitment Status : Terminated (The population described via ex- and inclusion criteria did not excisit)
First Posted : November 1, 2009
Last Update Posted : June 8, 2011
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 Device: Grindcare - inactive Not Applicable

Layout table for study information
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 Sleep Bruxism
Study Start Date : October 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
Experimental: Grindcare
24 patients receiving active treatment
Device: Grindcare
Active treatment

Placebo Comparator: Placebo treatment
24 patients receive a placebo treatment
Device: Grindcare - inactive
Placebo treatment

Primary Outcome Measures :
  1. Reduction in the electromyography (EMG) activity per hour per night [ Time Frame: 10 weeks after start of treatment ]

Secondary Outcome Measures :
  1. Evaluation of long-term effect of FES on the EMG activity [ Time Frame: a 4 weeks period after end og treatment with FES ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
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)

Exclusion Criteria:

  • Contraindication of concommitant diseases for the study judged by investigator
  • 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): NCT01005511

Layout table for location information
Odontologisk Institute
Aarhus, Denmark, 8000
Sponsors and Collaborators
Medotech A/S
Layout table for investigator information
Study Chair: pernille Wendelboe, MsSc (Odont) Medotech A/S
Layout table for additonal information
Responsible Party: Peter Svensson, Aarhus University Dentist School Identifier: NCT01005511    
Other Study ID Numbers: TMD-01
First Posted: November 1, 2009    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: October 2009
Keywords provided by Medotech A/S:
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Bruxism
Tooth Diseases
Stomatognathic Diseases
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders