Temporomandibular DisorderNCT01000389
A Clinical Trial of the Optimal Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep Bruxism
A study testing Grindcare® (Biofeedback) in people with Temporomandibular Disorder and Headache, run by Medotech A/S at 1 site in Denmark.
Trial summary
To investigate the effect of the treatment with Grindcare® on the parafunction of the muscles- and jaw activity (Bruxism) during sleep. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Disorder, Headache
- What is being tested?
- Grindcare® (Biofeedback)
- Type of treatment
- Medical device
- How many people
- 23 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2009to Mar 2011
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- RDC-TMD diagnosis
- Verified sleep bruxism
- More than 18 Years
- Signed ICF
Who cannot join
- Contraindication of concomitant medication and diseases judged by investigator
- Pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the effect of the treatment with Grindcare® on the parafunction of the muscles- and jaw activity (Bruxism) during sleep.
- Conditions
- Temporomandibular Disorder, Headache
- Being tested
- Grindcare® (Biofeedback)
- Medical subject headings
- Temporomandibular Joint Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grindcare® (Biofeedback)Device
Active treatment with functional electrical stimulation
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of number of grinds per hour per night
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medotech A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pernille Wendelboe, MsSc (Odont), Study chair, Medotech A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000389
- Sponsor's protocol ID
- TMD-02
- Status last verified
- Jun 2011
- First submitted
- 22 Oct 2009
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of the Optimal Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep Bruxism
- ClinicalTrials.gov ID
- NCT01000389
- Acronym / sponsor ID
- TMD-02
- Conditions
- Temporomandibular Disorder, Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Medotech A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 23 Oct 2009 (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.
To investigate the effect of the treatment with Grindcare® on the parafunction of the muscles- and jaw activity (Bruxism) during sleep.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- RDC-TMD diagnosis
- Verified sleep bruxism
- More than 18 Years
- Signed ICF
Key exclusion criteria (2 listed)
- Contraindication of concomitant medication and diseases judged by investigator
- Pacemaker
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® (Biofeedback)Active treatment with functional electrical stimulation | Device | – |
Primary outcome
Reduction of number of grinds per hour per night
Time frame: 7 weeks
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 8 Jun 2011.
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Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
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R01_Pilot Jaw Muscle Phenotypes
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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.
Pernille Wendelboe, MsSc (Odont) study chair
Medotech A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grindcare® (Biofeedback) in people with Temporomandibular Disorder and Headache, run by Medotech A/S at 1 site in Denmark.
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 2 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 8 Jun 2011. 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 Denmark. 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.
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?
Reduction of number of grinds per hour per night (time frame: 7 weeks). 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 8 Jun 2011.