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NCT01000389 Clinical Trial

A Clinical Trial of the Optimal Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep Bruxism

Headache Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01000389
Other study ID # TMD-02
Secondary ID
Status Completed
Phase N/A
First received October 22, 2009
Last updated June 7, 2011
Start date October 2009
Est. completion date March 2011

Study information
Verified date June 2011
Source Medotech A/S
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial Summary

To investigate the effect of the treatment with Grindcare® on the parafunction of the muscles- and jaw activity (Bruxism) during sleep.

Recruitment information / eligibility
Status Completed
Enrollment 23
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Grindcare® (Biofeedback)
Active treatment with functional electrical stimulation

Locations
Country Name City State
Denmark Odontologisk Institute Aarhus

Sponsors (1)
Lead Sponsor Collaborator
Medotech A/S

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction of number of grinds per hour per night 7 weeks No
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