Status:

COMPLETED

Interest of the BRUXENSE Occlusal Splints for Bruxism Diagnosis: a Feasibility Study

Lead Sponsor:

Hospices Civils de Lyon

Conditions:

Bruxism, Sleep-Related

Eligibility:

All Genders

18-70 years

Phase:

NA

Brief Summary

There is no accurate diagnosis method for bruxism for now. Consequences of bruxism over teeth, muscles and articulation of the jaw are important. This study aims to develop a innovative tool in order...

Eligibility Criteria

Inclusion

  • adult from 18-70
  • patients diagnosed with bruxism according to the following criteria:
  • positive question at one of the following question:
  • are you aware of your grinding?
  • does your partner hear you grinding?
  • are you aware that you are frequently tighten your jaws during the day and/or the night?
  • are you tired and/or do experience jaws 'muscular pain in the morning.
  • presence of at least one criteria:
  • abnormal tooth wear or tooth prosthesis damages
  • Hypertrophy of the masseter muscles
  • patients agreeing to participate
  • patient able to understand and follow the protocol
  • patient with health insurance

Exclusion

  • patients with more than 2 missing tooth
  • Severe troubles to correctly close the mouth.
  • neurological disorder (Parkinson, Alzheimer) or psychiatric disorder
  • Sleep disorder (insomnia, narcolepsy, sleep apnea, restless leg disorder)
  • use of drugs that potentially impair sleep (benzodiazepines, neuroleptics, tricyclic antidepressants) alcohol or narcotics.
  • complete or partial removal dental prosthesis or orthodontic device
  • Patient under legal protection
  • pregnant women
  • Patients deprived of their freedom by a judicial or administrative decision

Key Trial Info

Start Date :

February 8 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 28 2018

Estimated Enrollment :

7 Patients enrolled

Trial Details

Trial ID

NCT03363204

Start Date

February 8 2018

End Date

December 28 2018

Last Update

December 19 2025

Active Locations (1)

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Service de Consultations et de Traitements Dentaires, Hospices Civils de Lyon

Lyon, France, France, 69007