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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:
Information provided by:
Medotech A/S
ClinicalTrials.gov Identifier:
NCT01000389
First received: October 22, 2009
Last updated: June 7, 2011
Last verified: June 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pernille Wendelboe, Medotech A/S
ClinicalTrials.gov 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:
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

ClinicalTrials.gov processed this record on May 22, 2013