NCT01005511

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
terminated

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
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

June 8, 2011

Status Verified

October 1, 2009

Enrollment Period

1 year

First QC Date

October 30, 2009

Last Update Submit

June 7, 2011

Conditions

Bruxism

Keywords

Bruxism

Outcome Measures

Primary Outcomes (1)

  • Reduction in the electromyography (EMG) activity per hour per night

    10 weeks after start of treatment

Secondary Outcomes (1)

  • Evaluation of long-term effect of FES on the EMG activity

    a 4 weeks period after end og treatment with FES

Study Arms (2)

Grindcare

EXPERIMENTAL

24 patients receiving active treatment

Device: Grindcare

Placebo treatment

PLACEBO COMPARATOR

24 patients receive a placebo treatment

Device: Grindcare - inactive

Interventions

GrindcareDEVICE

Active treatment

Grindcare
Grindcare - inactiveDEVICE

Placebo treatment

Placebo treatment

Eligibility Criteria

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

You may qualify if:

  • Signed and dated ICF
  • years or older
  • Fulfill the RDC-criteria for myofascial TMD diagnose (group 1a or 1b)

You may not qualify if:

  • Contraindication of concommitant diseases for the study judged by investigator
  • Patients who are using occlusal splints in the treatment period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odontologisk Institute

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Bruxism

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehavior

Study Officials

  • pernille Wendelboe, MsSc (Odont)

    Medotech A/S

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 30, 2009

First Posted

November 2, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2010

Study Completion

December 1, 2010

Last Updated

June 8, 2011

Record last verified: 2009-10

Locations

DK(1)