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A Clinical Trial of the Optimal Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep Bruxism

This study has been completed.
Information provided by:
Medotech A/S Identifier:
First received: October 22, 2009
Last updated: June 7, 2011
Last verified: June 2011
To investigate the effect of the treatment with Grindcare® on the parafunction of the muscles- and jaw activity (Bruxism) during sleep.

Condition Intervention
Temporomandibular Disorder
Device: Grindcare® (Biofeedback)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Medotech A/S:

Primary Outcome Measures:
  • Reduction of number of grinds per hour per night [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: October 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Grindcare® (Biofeedback)
    Active treatment with functional electrical stimulation

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
  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: NCT01000389

Odontologisk Institute
Aarhus, Denmark, 8000
Sponsors and Collaborators
Medotech A/S
Study Chair: Pernille Wendelboe, MsSc (Odont) Medotech A/S
  More Information

Additional Information:
Responsible Party: Pernille Wendelboe, Medotech A/S Identifier: NCT01000389     History of Changes
Other Study ID Numbers: TMD-02 
Study First Received: October 22, 2009
Last Updated: June 7, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes processed this record on October 21, 2016