Bruxism, Sleep-RelatedBRUXENSENCT03363204
Interest of the BRUXENSE Occlusal Splints for Bruxism Diagnosis: a Feasibility Study
A study testing BRUXENSE occlusal splint in people with Bruxism, Sleep-Related, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bruxism, Sleep-Related
- What is being tested?
- BRUXENSE occlusal splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2018to 28 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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?
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- 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
Who cannot join
- 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
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- Patient under legal protection
- pregnant women
- Patients deprived of their freedom by a judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Consultations et de Traitements Dentaires, Hospices Civils de Lyon
Lyon, France, 69007
About this 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.
- Conditions
- Bruxism, Sleep-Related
- Being tested
- BRUXENSE occlusal splint
- Medical subject headings
- Sleep Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| BRUXENSE | Experimental | Patients corresponding to selection criteria will use the BRUXENSE occlusal splint for 10 consecutive nights. Receives: Device: BRUXENSE occlusal splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At day 10
Secondary outcomes (3)
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
Measured: At day 10
Satisfaction scale score
Subject satisfaction will be assessed thanks to a numeric scale going from 0 (not satisfied at all) to 10 (completely satisfied)
Measured: At day 10
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.
Measured: At day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start8 Feb 2018
- Primary completion28 Dec 2018
- Study completion28 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bruxism, Sleep-RelatedStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363204
- Sponsor's protocol ID
- 69HCL17_0281
- Acronym
- BRUXENSE
- Status last verified
- Dec 2025
- First submitted
- 30 Nov 2017
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31914871
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the BRUXENSE Occlusal Splints for Bruxism Diagnosis: a Feasibility Study
- ClinicalTrials.gov ID
- NCT03363204
- Acronym / sponsor ID
- BRUXENSE / 69HCL17_0281
- Conditions
- Bruxism, Sleep-Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 28 Dec 2018 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 6 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BRUXENSE | Experimental | Device: BRUXENSE occlusal splintPatients corresponding to selection criteria will use the BRUXENSE occlusal splint for 10 consecutive nights. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- adult from 18-70
- patients diagnosed with bruxism according to the following criteria:
- positive question at one of the following question:
- presence of at least one criteria:
- patients agreeing to participate
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRUXENSE occlusal splintPatients 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. | Device | BRUXENSE |
Primary outcome
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.
3 secondary outcomes
Number of usable measurements
Time frame: At day 10
Satisfaction scale score
Time frame: At day 10
Proportion of patients diagnosed with bruxism
Time frame: At day 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 31914871Robin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRUXENSE occlusal splint in people with Bruxism, Sleep-Related, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient rate with successful use of BRUXENSE occlusal splint (time frame: At day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03363204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.