Treatment Period and Long-term Effect of Functional Elect... | NCT00807430

Studies
Treatment Period and Long-term Effect of Functional Electric Stimulation (FES) for Bruxism

NCT00807430

Sponsor

Medotech A/S

Status

Terminated

Last Update Posted

Oct 21, 2009Estimated

Enrollment

48Estimated

Phase

Not Applicable

Conditions

Bruxism

Interventions

Grindcare (Active)
Grindcare (Placebo - the device is not activated)

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Jun 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Dec 9, 2008

First Submission Date that Met QC Criteria

Dec 10, 2008

First Posted Date

Dec 11, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2009

Last Update Posted Date

Oct 21, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To investigate the effect of the treatment with Grindcare® on the muscles- and jaw symptoms and at the jaw muscle activity during sleep.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	24 patients receiving active treatment	Device: Grindcare (Active)
2	Placebo Comparator	Placebo treatment	Device: Grindcare (Placebo - the device is not activated)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Grindcare (Active)	Device	Active treatment	1
Grindcare (Placebo - the device is not activated)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary outcome is to reduce the EMG activity per hour per night		10 weeks after start of treatment

Secondary Outcomes

Measure	Description	Time Frame
Secondary outcome is to evaluate long-term effect of FES om EMG activity		after end of treatment with FES

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed and dated ICF
18 years or older
Fulfill the RDC-criteria for myofascial TMD diagnose (group 1a or 1b)
Average pain more that 3 on a Visual Analog scale (VAS) in the baseline period

Exclusion Criteria:

Contraindication of concommitant diseases for the study judged by investigator
Daily use of pain medication, e.g. prophylaxis against migraine or headache.
Patients who are using occlusal splints in the treatment period.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Troels B Mortensen	Medotech A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Odontologisk Institut		Aarhus C		8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D002012	Bruxism

Ancestor Terms

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D006184	Habits
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided