NCT01000389

Brief Summary

To investigate the effect of the treatment with Grindcare® on the parafunction of the muscles- and jaw activity (Bruxism) during sleep.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

June 8, 2011

Status Verified

June 1, 2011

Enrollment Period

1.4 years

First QC Date

October 22, 2009

Last Update Submit

June 7, 2011

Conditions

Temporomandibular DisorderHeadache

Outcome Measures

Primary Outcomes (1)

  • Reduction of number of grinds per hour per night

    7 weeks

Interventions

Grindcare® (Biofeedback)DEVICE

Active treatment with functional electrical stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Contraindication of concomitant medication and diseases judged by investigator
  • Pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odontologisk Institute

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Temporomandibular Joint DisordersHeadache

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Pernille Wendelboe, MsSc (Odont)

    Medotech A/S

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 22, 2009

First Posted

October 23, 2009

Study Start

October 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

June 8, 2011

Record last verified: 2011-06

Locations

DK(1)