Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep Bruxism

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01005511
• Other study ID #: TMD-01
• 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

• Bruxism
• Sleep Bruxism

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