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

Not Applicable

Completed

• Conditions: Temporomandibular Disorder; Headache

• Registration Number: NCT01000389
• Lead Sponsor: Medotech A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-22
• Study First Submitted QC: 2009-10-22
• Study First Posted: 2009-10-23
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-07
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Reduction of number of grinds per hour per night	7 weeks

Trial Locations

Locations (1)

Odontologisk Institute; 🇩🇰 Aarhus, Denmark