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Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep Bruxism

This study has been terminated.
(The population described via ex- and inclusion criteria did not excisit)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01005511
First Posted: November 2, 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 muscles- and jaw symptoms and at the jaw muscle activity during sleep.

Condition Intervention
Bruxism Device: Grindcare Device: Grindcare - inactive

Study Type: Interventional
Study Design: 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

Further study details as provided by Medotech A/S:

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

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

Estimated Enrollment: 48
Study Start Date: October 2009
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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:

  • 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.
  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): NCT01005511


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

Responsible Party: Peter Svensson, Aarhus University Dentist School
ClinicalTrials.gov Identifier: NCT01005511     History of Changes
Other Study ID Numbers: TMD-01
First Submitted: October 30, 2009
First Posted: November 2, 2009
Last Update Posted: June 8, 2011
Last Verified: October 2009

Keywords provided by Medotech A/S:
Bruxism

Additional relevant MeSH terms:
Bruxism
Sleep Bruxism
Tooth Diseases
Stomatognathic Diseases
Parasomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders