A Clinical Trial of the Optimal Treatment Period and Long... | NCT01000389

Studies
A Clinical Trial of the Optimal Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep Bruxism

NCT01000389

Sponsor

Medotech A/S

Status

Completed

Last Update Posted

Jun 8, 2011Estimated

Enrollment

23Actual

Phase

Not Applicable

Conditions

Temporomandibular Disorder
Headache

Interventions

Grindcare® (Biofeedback)

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

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Oct 22, 2009

First Submission Date that Met QC Criteria

Oct 22, 2009

First Posted Date

Oct 23, 2009Estimated

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

Jun 7, 2011

Last Update Posted Date

Jun 8, 2011Estimated

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 parafunction of the muscles- and jaw activity (Bruxism) 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

23Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Grindcare® (Biofeedback)	Device	Active treatment with functional electrical stimulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction of number of grinds per hour per night		7 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

RDC-TMD diagnosis
Verified sleep bruxism
More than 18 Years
Signed ICF

Exclusion Criteria:

Contraindication of concomitant medication and diseases judged by investigator
Pacemaker

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
Pernille Wendelboe, MsSc (Odont)	Medotech A/S	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Odontologisk Institute		Aarhus		8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D013705	Temporomandibular Joint Disorders
D006261	Headache

Ancestor Terms

ID	Term
D017271	Craniomandibular Disorders
D008336	Mandibular Diseases
D007571	Jaw Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001676	Biofeedback, Psychology

Ancestor Terms

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D001521	Behavior Therapy

Browse Leaves

Not provided

Browse Branches

Not provided