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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Mental Disorders
Nervous System Diseases
Parasomnias
Sleep Disorders
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on October 23, 2014