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

This study has been terminated.
Sponsor:
Information provided by:
Medotech A/S
ClinicalTrials.gov Identifier:
NCT00807430
First received: December 9, 2008
Last updated: October 20, 2009
Last verified: October 2009
History of Changes
  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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcome is to evaluate long-term effect of FES om EMG activity [ Time Frame: after end of treatment with FES ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Peter Svensson, Aarhus University Dentist School
ClinicalTrials.gov Identifier: NCT00807430     History of Changes
Other Study ID Numbers: TMD-00
Study First Received: December 9, 2008
Last Updated: October 20, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Medotech A/S:
Bruxism
EMG
Biofeedback

Additional relevant MeSH terms:
Bruxism
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 16, 2013