Back to resultsTreatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep Bruxism
Primary Purpose
Bruxism
Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Grindcare
Grindcare - inactive
Sponsored by
About this trial
This is an interventional treatment trial for Bruxism focused on measuring Bruxism
Eligibility 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.
Sites / Locations
- Odontologisk Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Grindcare
Placebo treatment
Arm Description
24 patients receiving active treatment
24 patients receive a placebo treatment
Outcomes
Primary Outcome Measures
Reduction in the electromyography (EMG) activity per hour per night
Secondary Outcome Measures
Evaluation of long-term effect of FES on the EMG activity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01005511
Brief Title
Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep Bruxism
Official Title
A Single Centre, Randomised, Clinical Placebo Controlled Study of the Optimal Treatment and Long-term Effect of FES on Sleep Bruxism
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Terminated
Why Stopped
The population described via ex- and inclusion criteria did not excisit
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
December 2010 (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
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
Grindcare
Arm Type
Experimental
Arm Description
24 patients receiving active treatment
Arm Title
Placebo treatment
Arm Type
Placebo Comparator
Arm Description
24 patients receive a placebo treatment
Intervention Type
Device
Intervention Name(s)
Grindcare
Intervention Description
Active treatment
Intervention Type
Device
Intervention Name(s)
Grindcare - inactive
Intervention Description
Placebo treatment
Primary Outcome Measure Information:
Title
Reduction in the electromyography (EMG) activity per hour per night
Time Frame
10 weeks after start of treatment
Secondary Outcome Measure Information:
Title
Evaluation of long-term effect of FES on the EMG activity
Time Frame
a 4 weeks period after end og 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)
Exclusion Criteria:
Contraindication of concommitant diseases for the study judged by investigator
Patients who are using occlusal splints in the treatment period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
pernille Wendelboe, MsSc (Odont)
Organizational Affiliation
Medotech A/S
Official's Role
Study Chair
Facility Information:
Facility Name
Odontologisk Institute
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep Bruxism
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