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
  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
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: 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 September 18, 2014