Back to resultsTreatment Period and Long-term Effect of Functional Electric Stimulation (FES) for Bruxism
Primary Purpose
Bruxism
Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Grindcare (Active)
Grindcare (Placebo - the device is not activated)
Sponsored by
About this trial
This is an interventional treatment trial for Bruxism focused on measuring Bruxism, EMG, Biofeedback
Eligibility 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.
Sites / Locations
- Odontologisk Institut
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
24 patients receiving active treatment
Placebo treatment
Outcomes
Primary Outcome Measures
Primary outcome is to reduce the EMG activity per hour per night
Secondary Outcome Measures
Secondary outcome is to evaluate long-term effect of FES om EMG activity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00807430
Brief Title
Treatment Period and Long-term Effect of Functional Electric Stimulation (FES) for Bruxism
Official Title
A Single Centre, Randomised, Clinical Placebo Controlled Study of the Optimal Treatment and Long-term Effect of FES on Bruxism
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Terminated
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medotech A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate the effect of the treatment with Grindcare® on the muscles- and jaw symptoms and at the jaw muscle activity during sleep.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bruxism
Keywords
Bruxism, EMG, Biofeedback
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
24 patients receiving active treatment
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo treatment
Intervention Type
Device
Intervention Name(s)
Grindcare (Active)
Intervention Description
Active treatment
Intervention Type
Device
Intervention Name(s)
Grindcare (Placebo - the device is not activated)
Intervention Description
Placebo treatment
Primary Outcome Measure Information:
Title
Primary outcome is to reduce the EMG activity per hour per night
Time Frame
10 weeks after start of treatment
Secondary Outcome Measure Information:
Title
Secondary outcome is to evaluate long-term effect of FES om EMG activity
Time Frame
after end of treatment with FES
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Troels B Mortensen
Organizational Affiliation
Medotech A/S
Official's Role
Study Director
Facility Information:
Facility Name
Odontologisk Institut
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Treatment Period and Long-term Effect of Functional Electric Stimulation (FES) for Bruxism
We'll reach out to this number within 24 hrs