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

Primary Purpose

Bruxism, Sleep-Related

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
BRUXENSE occlusal splint
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bruxism, Sleep-Related

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BRUXENSE

Arm Description

Patients corresponding to selection criteria will use the BRUXENSE occlusal splint for 10 consecutive nights.

Outcomes

Primary Outcome Measures

Patient rate with successful use of BRUXENSE occlusal splint
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 Outcome Measures

Number of usable measurements
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
Satisfaction scale score
Subject satisfaction will be assessed thanks to a numeric scale going from 0 (not satisfied at all) to 10 (completely satisfied)
Proportion of patients diagnosed with bruxism
Proportion of patients diagnosed with bruxism according to the BRUXENSE occlusal splints after the analysis of the data collected during 10 days.

Full Information

First Posted
November 30, 2017
Last Updated
August 22, 2019
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03363204
Brief Title
Interest of the BRUXENSE Occlusal Splints for Bruxism Diagnosis: a Feasibility Study
Acronym
BRUXENSE
Official Title
Interest of the BRUXENSE Occlusal Splints for Bruxism Diagnosis: a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
December 28, 2018 (Actual)
Study Completion Date
December 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 to accurately rapidly diagnose bruxism in ambulatory evaluation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bruxism, Sleep-Related

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BRUXENSE
Arm Type
Experimental
Arm Description
Patients corresponding to selection criteria will use the BRUXENSE occlusal splint for 10 consecutive nights.
Intervention Type
Device
Intervention Name(s)
BRUXENSE occlusal splint
Intervention Description
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 Outcome Measure Information:
Title
Patient rate with successful use of BRUXENSE occlusal splint
Description
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.
Time Frame
At day 10
Secondary Outcome Measure Information:
Title
Number of usable measurements
Description
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
Time Frame
At day 10
Title
Satisfaction scale score
Description
Subject satisfaction will be assessed thanks to a numeric scale going from 0 (not satisfied at all) to 10 (completely satisfied)
Time Frame
At day 10
Title
Proportion of patients diagnosed with bruxism
Description
Proportion of patients diagnosed with bruxism according to the BRUXENSE occlusal splints after the analysis of the data collected during 10 days.
Time Frame
At day 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Service de Consultations et de Traitements Dentaires, Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69007
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
31914871
Citation
Robin O, Claude A, Gehin C, Massot B, McAdams E. Recording of bruxism events in sleeping humans at home with a smart instrumented splint. Cranio. 2022 Jan;40(1):14-22. doi: 10.1080/08869634.2019.1708608. Epub 2020 Jan 8.
Results Reference
derived

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

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