Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep Bruxism

NCT ID: NCT01005511

Last Updated: 2011-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Bruxism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Grindcare

24 patients receiving active treatment

Group Type EXPERIMENTAL

Grindcare

Intervention Type DEVICE

Active treatment

Placebo treatment

24 patients receive a placebo treatment

Group Type PLACEBO_COMPARATOR

Grindcare - inactive

Intervention Type DEVICE

Placebo treatment

Interventions

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Grindcare

Active treatment

Intervention Type DEVICE

Grindcare - inactive

Placebo treatment

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medotech A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Aarhus University Dentist School

Principal Investigators

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pernille Wendelboe, MsSc (Odont)

Role: STUDY_CHAIR

Medotech A/S

Locations

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Odontologisk Institute

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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TMD-01

Identifier Type: -

Identifier Source: org_study_id

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