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

August 22, 2019 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69007
        • Service de Consultations et de Traitements Dentaires, Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BRUXENSE
Patients corresponding to selection criteria will use the BRUXENSE occlusal splint for 10 consecutive nights.
Device: BRUXENSE occlusal splint
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At day 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At day 10
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)
At day 10
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.
At day 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2018

Primary Completion (Actual)

December 28, 2018

Study Completion (Actual)

December 28, 2018

Study Registration Dates

First Submitted

November 30, 2017

First Submitted That Met QC Criteria

November 30, 2017

First Posted (Actual)

December 6, 2017

Study Record Updates

Last Update Posted (Actual)

August 26, 2019

Last Update Submitted That Met QC Criteria

August 22, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL17_0281

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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