Craniomandibular Dysfunction, Orofacial Pain
Conditions
Brief summary
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.
Interventions
DEVICEGrindcare
DEVICEMichigan-type occlusal splint
Sponsors
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Worst perceived pain | 1 week |
Countries
Germany
Outcome results
None listed