NCT03363204

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

February 8, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2018

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

November 30, 2017

Last Update Submit

December 13, 2025

Conditions

Bruxism, Sleep-Related

Outcome Measures

Primary Outcomes (1)

  • 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.

    At day 10

Secondary Outcomes (3)

  • Number of usable measurements

    At day 10

  • Satisfaction scale score

    At day 10

  • Proportion of patients diagnosed with bruxism

    At day 10

Study Arms (1)

BRUXENSE

EXPERIMENTAL

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

Device: BRUXENSE occlusal splint

Interventions

BRUXENSE occlusal splintDEVICE

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.

BRUXENSE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lyon, France, 69007, France

Location

Related Publications (1)

  • 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.

    PMID: 31914871RESULT

MeSH Terms

Conditions

Sleep Bruxism

Condition Hierarchy (Ancestors)

BruxismTooth DiseasesStomatognathic DiseasesParasomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2017

First Posted

December 6, 2017

Study Start

February 8, 2018

Primary Completion

December 28, 2018

Study Completion

December 28, 2018

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations

FR(1)