Back to resultsA Clinical Trial of the Optimal Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep Bruxism
Primary Purpose
Temporomandibular Disorder, Headache
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Grindcare® (Biofeedback)
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Disorder
Eligibility Criteria
Inclusion Criteria:
- RDC-TMD diagnosis
- Verified sleep bruxism
- More than 18 Years
- Signed ICF
Exclusion Criteria:
- Contraindication of concomitant medication and diseases judged by investigator
- Pacemaker
Sites / Locations
- Odontologisk Institute
Outcomes
Primary Outcome Measures
Reduction of number of grinds per hour per night
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01000389
Brief Title
A Clinical Trial of the Optimal Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep Bruxism
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (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 parafunction of the muscles- and jaw activity (Bruxism) during sleep.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder, Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Grindcare® (Biofeedback)
Intervention Description
Active treatment with functional electrical stimulation
Primary Outcome Measure Information:
Title
Reduction of number of grinds per hour per night
Time Frame
7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
RDC-TMD diagnosis
Verified sleep bruxism
More than 18 Years
Signed ICF
Exclusion Criteria:
Contraindication of concomitant medication and diseases judged by investigator
Pacemaker
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
A Clinical Trial of the Optimal Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep Bruxism
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