Craniomandibular DysfunctionPhase 2NCT01949064
Use of Electromyography With Bio-Feedback for the Treatment of Craniomandibular Disorders
A Phase 2 study testing Grindcare and Michigan-type occlusal splint in people with Craniomandibular Dysfunction and Orofacial Pain, run by Heidelberg University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Craniomandibular Dysfunction, Orofacial Pain
- What is being tested?
- Grindcare and Michigan-type occlusal splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2011to Jan 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form
- Age between 18 and 70 years
- Non-chronic painful CMD with/without mandibular movement restriction
- Female
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Craniomandibular Dysfunction, Orofacial Pain
- Being tested
- Grindcare, Michigan-type occlusal splint
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrindcareDevice
Michigan-type occlusal splintDevice
| Study group | Role | What they receive |
|---|---|---|
| Michigan-type occlusal splint | Active comparator | Occlusal splint, Michigan-type Receives: Device: Michigan-type occlusal splint |
| Grindcare | Active comparator | Biofeedback device Receives: Device: Grindcare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Worst perceived pain
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startJul 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniomandibular DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giannakopoulos Nikolaos, Heidelberg University
- Investigators
- Nikolaos Nikitas Giannakopoulos, Dr.med.dent,M.Sc, Principal investigator, Poliklinik für Zahnärztliche Prothetik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949064
- Sponsor's protocol ID
- BioGC1UHeidelberg
- Status last verified
- Dec 2014
- First submitted
- 17 Sep 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anwendung Von Elektromyographie Mit Gleichzeitigem Bio-Feedback Zur Behandlung Von Craniomandibulären Dysfunktionen Und/Oder Bruxismus.
- ClinicalTrials.gov ID
- NCT01949064
- Acronym / sponsor ID
- BioGC1UHeidelberg
- Conditions
- Craniomandibular Dysfunction, Orofacial Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 24 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Michigan-type occlusal splint | Active comparator | Device: Michigan-type occlusal splintOcclusal splint, Michigan-type |
| Grindcare | Active comparator | Device: GrindcareBiofeedback device |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent form
- Age between 18 and 70 years
- Non-chronic painful CMD with/without mandibular movement restriction
- Female
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grindcare | Device | Grindcare |
| Michigan-type occlusal splint | Device | Michigan-type occlusal splint |
Primary outcome
Worst perceived pain
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolaos Nikitas Giannakopoulos, Dr.med.dent,M.Sc principal investigator
Poliklinik für Zahnärztliche Prothetik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Grindcare and Michigan-type occlusal splint in people with Craniomandibular Dysfunction and Orofacial Pain, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Worst perceived pain (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.