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Treatment Period and Long-term Effect of Functional Electric Stimulation (FES) for Bruxism

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00807430
First Posted: December 11, 2008
Last Update Posted: October 21, 2009
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 (Active) Device: Grindcare (Placebo - the device is not activated)

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 Bruxism

Further study details as provided by Medotech A/S:

Primary Outcome Measures:
  • Primary outcome is to reduce the EMG activity per hour per night [ Time Frame: 10 weeks after start of treatment ]

Secondary Outcome Measures:
  • Secondary outcome is to evaluate long-term effect of FES om EMG activity [ Time Frame: after end of treatment with FES ]

Estimated Enrollment: 48
Study Start Date: February 2009
Study Completion Date: October 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
24 patients receiving active treatment
Device: Grindcare (Active)
Active treatment
Placebo Comparator: 2
Placebo treatment
Device: Grindcare (Placebo - the device is not activated)
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)
  • Average pain more that 3 on a Visual Analog scale (VAS) in the baseline period

Exclusion Criteria:

  • Contraindication of concommitant diseases for the study judged by investigator
  • Daily use of pain medication, e.g. prophylaxis against migraine or headache.
  • 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): NCT00807430


Locations
Denmark
Odontologisk Institut
Aarhus C, Denmark, 8000
Sponsors and Collaborators
Medotech A/S
Investigators
Study Director: Troels B Mortensen Medotech A/S
  More Information

Responsible Party: Peter Svensson, Aarhus University Dentist School
ClinicalTrials.gov Identifier: NCT00807430     History of Changes
Other Study ID Numbers: TMD-00
First Submitted: December 9, 2008
First Posted: December 11, 2008
Last Update Posted: October 21, 2009
Last Verified: October 2009

Keywords provided by Medotech A/S:
Bruxism
EMG
Biofeedback

Additional relevant MeSH terms:
Bruxism
Tooth Diseases
Stomatognathic Diseases