NCT00807430

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 Feb 2009

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

December 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

October 21, 2009

Status Verified

October 1, 2009

Enrollment Period

4 months

First QC Date

December 9, 2008

Last Update Submit

October 20, 2009

Conditions

Bruxism

Keywords

BruxismEMGBiofeedback

Outcome Measures

Primary Outcomes (1)

  • Primary outcome is to reduce the EMG activity per hour per night

    10 weeks after start of treatment

Secondary Outcomes (1)

  • Secondary outcome is to evaluate long-term effect of FES om EMG activity

    after end of treatment with FES

Study Arms (2)

1

EXPERIMENTAL

24 patients receiving active treatment

Device: Grindcare (Active)

2

PLACEBO COMPARATOR

Placebo treatment

Device: Grindcare (Placebo - the device is not activated)

Interventions

Grindcare (Active)DEVICE

Active treatment

1
Grindcare (Placebo - the device is not activated)DEVICE

Placebo treatment

2

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)
  • Average pain more that 3 on a Visual Analog scale (VAS) in the baseline period

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odontologisk Institut

Aarhus C, 8000, Denmark

Location

MeSH Terms

Conditions

Bruxism

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehavior

Study Officials

  • Troels B Mortensen

    Medotech A/S

    STUDY DIRECTOR

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

December 9, 2008

First Posted

December 11, 2008

Study Start

February 1, 2009

Primary Completion

June 1, 2009

Study Completion

October 1, 2009

Last Updated

October 21, 2009

Record last verified: 2009-10

Locations

DK(1)