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A Clinical Trial of the Optimal 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: NCT01000389
Recruitment Status : Completed
First Posted : October 23, 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 parafunction of the muscles- and jaw activity (Bruxism) during sleep.

Condition or disease Intervention/treatment Phase
Temporomandibular Disorder Headache Device: Grindcare® (Biofeedback) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Intervention Details:
  • Device: Grindcare® (Biofeedback)
    Active treatment with functional electrical stimulation

Primary Outcome Measures :
  1. Reduction of number of grinds per hour per night [ Time Frame: 7 weeks ]

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.

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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:

  • RDC-TMD diagnosis
  • Verified sleep bruxism
  • More than 18 Years
  • Signed ICF

Exclusion Criteria:

  • Contraindication of concomitant medication and diseases judged by investigator
  • Pacemaker

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): NCT01000389

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Odontologisk Institute
Aarhus, Denmark, 8000
Sponsors and Collaborators
Medotech A/S
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Study Chair: Pernille Wendelboe, MsSc (Odont) Medotech A/S
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Responsible Party: Pernille Wendelboe, Medotech A/S Identifier: NCT01000389    
Other Study ID Numbers: TMD-02
First Posted: October 23, 2009    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011
Additional relevant MeSH terms:
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Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Neurologic Manifestations
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes