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Completed

NCT Number: NCT03363204

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

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 to accurately rapidly diagnose bruxism in ambulatory evaluation.

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Key information

Conditions

Bruxism, Sleep-Related Bruxism Mental Disorders Nervous System Diseases Parasomnias Sleep Bruxism Sleep Wake Disorders Stomatognathic Diseases Tooth Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Lyon, France, 69007

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

BRUXENSE occlusal splint

Device

Patients participating will put the BRUXENSE occlusal splint each night. During the night the device will collect data potentially related to bruxism. After each night the device will be cleaned with water and toothpaste and charged. This routine will be conducted over 10 consecutive nights.

Primary outcomes

  1. Patient rate with successful use of BRUXENSE occlusal splint

    Time frame: At day 10

    The BRUXENSE occlusal splints correct use in real situation will be evaluated by measuring the percentage of subjects able to use this occlusal splints during 10 consecutive nights (6 hours minimum) without any pain or any discomfort. 10 nights is the necessary delay to record sufficient data to make a diagnosis.

Secondary outcomes

  1. Number of usable measurements

    Time frame: At day 10

    The quality of collected data will be determined by the number of measurements that can be used to make a diagnosis of bruxism after 10 consecutive nights

  2. Satisfaction scale score

    Time frame: At day 10

    Subject satisfaction will be assessed thanks to a numeric scale going from 0 (not satisfied at all) to 10 (completely satisfied)

  3. Proportion of patients diagnosed with bruxism

    Time frame: At day 10

    Proportion of patients diagnosed with bruxism according to the BRUXENSE occlusal splints after the analysis of the data collected during 10 days.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: BRUXENSE

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 6, 2017
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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