Bruxism Clinical Trial
Official title:
A Single Centre, Randomised, Clinical Placebo Controlled Study of the Optimal Treatment and Long-term Effect of FES on Sleep Bruxism
To investigate the effect of the treatment with Grindcare® on the muscles- and jaw symptoms and at the jaw muscle activity during sleep.
Status | Terminated |
Enrollment | 48 |
Est. completion date | December 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Odontologisk Institute | Aarhus |
Lead Sponsor | Collaborator |
---|---|
Medotech A/S |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in the electromyography (EMG) activity per hour per night | 10 weeks after start of treatment | No | |
Secondary | Evaluation of long-term effect of FES on the EMG activity | a 4 weeks period after end og treatment with FES | No |
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