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

October 20, 2009 updated by: Medotech A/S

A Single Centre, Randomised, Clinical Placebo Controlled Study of the Optimal Treatment and Long-term Effect of FES on Bruxism

To investigate the effect of the treatment with Grindcare® on the muscles- and jaw symptoms and at the jaw muscle activity during sleep.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus C, Denmark, 8000
        • Odontologisk Institut

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo treatment
Device: Grindcare (Placebo - the device is not activated)
Placebo treatment
Experimental: 1
24 patients receiving active treatment
Device: Grindcare (Active)
Active treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medotech A/S

Investigators

  • Study Director: Troels B Mortensen, Medotech A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

December 9, 2008

First Submitted That Met QC Criteria

December 10, 2008

First Posted (Estimate)

December 11, 2008

Study Record Updates

Last Update Posted (Estimate)

October 21, 2009

Last Update Submitted That Met QC Criteria

October 20, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMD-00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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