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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01000389
First Posted: October 23, 2009
Last Update Posted: June 8, 2011
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.
Information provided by:
Medotech A/S
  Purpose
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 Headache Device: Grindcare® (Biofeedback)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 ]

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
  Eligibility

Information from the National Library of Medicine

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

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
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 ClinicalTrials.gov identifier (NCT number): NCT01000389


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

Additional Information:
Responsible Party: Pernille Wendelboe, Medotech A/S
ClinicalTrials.gov Identifier: NCT01000389     History of Changes
Other Study ID Numbers: TMD-02
First Submitted: October 22, 2009
First Posted: October 23, 2009
Last Update Posted: June 8, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Headache
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Pain
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