BruxismNCT01005511
Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep Bruxism
A study testing Grindcare and Grindcare - inactive in people with Bruxism, run by Medotech A/S at 1 site in Denmark.
Trial summary
To investigate the effect of the treatment with Grindcare® on the muscles- and jaw symptoms and at the jaw muscle activity during sleep. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bruxism
- What is being tested?
- Grindcare and Grindcare - inactive
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2009to Dec 2010
- 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
- Signed and dated ICF
- 18 years or older
- Fulfill the RDC-criteria for myofascial TMD diagnose (group 1a or 1b)
Who cannot join
- Contraindication of concommitant diseases for the study judged by investigator
- Patients who are using occlusal splints in the treatment period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Centre, Randomised, Clinical Placebo Controlled Study of the Optimal Treatment and Long-term Effect of FES on Sleep Bruxism
To investigate the effect of the treatment with Grindcare® on the muscles- and jaw symptoms and at the jaw muscle activity during sleep.
- Conditions
- Bruxism
- Being tested
- Grindcare, Grindcare - inactive
- Keywords
- Bruxism
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GrindcareDevice
Active treatment
Grindcare - inactiveDevice
Placebo treatment
| Study group | Role | What they receive |
|---|---|---|
| Grindcare | Experimental | 24 patients receiving active treatment Receives: Device: Grindcare |
| Placebo treatment | Placebo comparator | 24 patients receive a placebo treatment Receives: Device: Grindcare - inactive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the electromyography (EMG) activity per hour per night
Measured: 10 weeks after start of treatment
Secondary outcomes (1)
Evaluation of long-term effect of FES on the EMG activity
Measured: a 4 weeks period after end og treatment with FES
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionDec 2010
Why it stopped: The population described via ex- and inclusion criteria did not excisit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BruxismStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
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
- NCT01005511
- Sponsor's protocol ID
- TMD-01
- Status last verified
- Oct 2009
- First submitted
- 30 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 Single Centre, Randomised, Clinical Placebo Controlled Study of the Optimal Treatment and Long-term Effect of FES on Sleep Bruxism
- ClinicalTrials.gov ID
- NCT01005511
- Acronym / sponsor ID
- TMD-01
- Conditions
- Bruxism
- Keywords
- Bruxism
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The population described via ex- and inclusion criteria did not excisit
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Medotech A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 2 Nov 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 muscles- and jaw symptoms and at the jaw muscle activity during sleep.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grindcare | Experimental | Device: Grindcare24 patients receiving active treatment |
| Placebo treatment | Placebo comparator | Device: Grindcare - inactive24 patients receive a placebo treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed and dated ICF
- 18 years or older
- Fulfill the RDC-criteria for myofascial TMD diagnose (group 1a or 1b)
Key exclusion criteria (2 listed)
- Contraindication of concommitant diseases for the study judged by investigator
- Patients who are using occlusal splints in the treatment period.
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 |
|---|---|---|
| GrindcareActive treatment | Device | Grindcare |
| Grindcare - inactivePlacebo treatment | Device | Placebo treatment |
Primary outcome
Reduction in the electromyography (EMG) activity per hour per night
Time frame: 10 weeks after start of treatment
1 secondary outcome
Evaluation of long-term effect of FES on the EMG activity
Time frame: a 4 weeks period after end og treatment with FES
Results and safety
The study was stopped early (reason given: The population described via ex- and inclusion criteria did not excisit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
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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 and Grindcare - inactive in people with Bruxism, 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 3 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: stopped early, 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: The population described via ex- and inclusion criteria did not excisit). Results are not available in the source record.
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 in the electromyography (EMG) activity per hour per night (time frame: 10 weeks after start of treatment). 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.