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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01005511
Other study ID # TMD-01
Secondary ID
Status Terminated
Phase N/A
First received October 30, 2009
Last updated June 7, 2011
Start date October 2009
Est. completion date December 2010

Study information

Verified date October 2009
Source Medotech A/S
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National 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 muscles- and jaw symptoms and at the jaw muscle activity during sleep.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Grindcare
Active treatment
Grindcare - inactive
Placebo treatment

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 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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