- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01949064
Use of Electromyography With Bio-Feedback for the Treatment of Craniomandibular Disorders
Anwendung Von Elektromyographie Mit Gleichzeitigem Bio-Feedback Zur Behandlung Von Craniomandibulären Dysfunktionen Und/Oder Bruxismus.
The treatment of craniomandibular disorders is a challenging task. Many different treatments are yet available with occlusal splints being one of the most commonly used. A relative new diagnostic and treatment alternative is the Grindcare device. This enables the electromyographic (EMG) assessment of the activity of the temporal muscle and the contigent electrical stimulation of this muscle as bio-feedback whenever the EMG activity exceeds a certain limit. This stimulation results to a sudden break of the muscle activity.
Aim of this study is to compare the therapeutic efficacy of the Grindcare device in pain reduction at female non-chronic CMD patients to that of a Michigan-type splint. Our null-hypothesis was that there is no difference between the device and the splint in the reduction of pain intensity.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Heidelberg, Germany, 69120
- Poliklinik für Zahnärztliche Prothetik
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Signed informed consent form
- Age between 18 and 70 years
- Non-chronic painful CMD with/without mandibular movement restriction
- Female
Exclusion Criteria:
- Pregnancy or breastfeeding
- Chronic Pain Status higher than 2
- Known allergic reaction against the gel pads
- Electronic implants (pacemaker, defibrilator, insulin pump)
- Facial pain of dental or neuropathic etiology
- Traumatic injuries of the face / operations
- Dental treatment need
- Problems with swallowing reflex
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Michigan-type occlusal splint
Occlusal splint, Michigan-type
|
|
Active Comparator: Grindcare
Biofeedback device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Worst perceived pain
Time Frame: 1 week
|
1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nikolaos Nikitas Giannakopoulos, Dr.med.dent,M.Sc, Poliklinik für Zahnärztliche Prothetik
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BioGC1UHeidelberg
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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