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Use of Electromyography With Bio-Feedback for the Treatment of Craniomandibular Disorders

NCT ID: NCT01949064

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Craniomandibular Dysfunction Orofacial Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Michigan-type occlusal splint

Occlusal splint, Michigan-type

Group Type ACTIVE_COMPARATOR

Michigan-type occlusal splint

Intervention Type DEVICE

Grindcare

Biofeedback device

Group Type ACTIVE_COMPARATOR

Grindcare

Intervention Type DEVICE

Interventions

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Grindcare

Intervention Type DEVICE

Michigan-type occlusal splint

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Giannakopoulos Nikolaos

Dr.med.dent., M.Sc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nikolaos Nikitas Giannakopoulos, Dr.med.dent,M.Sc

Role: PRINCIPAL_INVESTIGATOR

Poliklinik für Zahnärztliche Prothetik

Locations

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Poliklinik für Zahnärztliche Prothetik

Heidelberg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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BioGC1UHeidelberg

Identifier Type: -

Identifier Source: org_study_id