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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:
Information provided by:
Medotech A/S
ClinicalTrials.gov Identifier:
NCT01005511
First received: October 30, 2009
Last updated: June 7, 2011
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
Device: Grindcare - inactive

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

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)

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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Peter Svensson, Aarhus University Dentist School
ClinicalTrials.gov Identifier: NCT01005511     History of Changes
Other Study ID Numbers: TMD-01
Study First Received: October 30, 2009
Last Updated: June 7, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Medotech A/S:
Bruxism

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

ClinicalTrials.gov processed this record on May 23, 2013