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Bruxism, Sleep-RelatedNCT06688474

A Sensor-enhanced Mouth Guard to Quantitatively Measure Bite Compression Forces.

An observational study of Bruxism, Sleep-Related, run by Otis Dental, LLC at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The goal of this study is to determine if the Otis Brux-Sensor Night Guard (OBSNG) can record the bite compression forces of participants with Bruxism. The main questions it aims to answer is: 1. Read more about this study

Who is it for?
Ages 18 to 50 years, men only
Conditions the study is for
Bruxism, Sleep-Related
How many people
2 participants
Where
1 siteUnited States
Study dates
5 Aug 2024to 31 Oct 2024
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 50 years
  • Men only
  • No healthy volunteers
  • Adult

Study population: US participants only.

Who may be able to join

  • 18-50 years of age
  • male and/or female
  • healthy with exception to being diagnosed with Bruxism.

Who cannot join

  • N/A

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Otis Dental

    San Francisco, California, 94118

Other trials in United States

About this study

Official title: Otis Brux-Sensor Night Guard - a Novel Wireless Custom Night Guard System With Pressure Sensors to Quantitatively Measure Bite Compression Forces and Alleviate Sleep Bruxism

The goal of this study is to determine if the Otis Brux-Sensor Night Guard (OBSNG) can record the bite compression forces of participants with Bruxism. The main questions it aims to answer is:

  1. Is it possible to design and miniaturize electrical hardware components small enough to fit onto the molar region of the custom night guard?
  2. If successfully miniaturized, will we be able to capture bite compression force profiles and optimize data collection for analysis?

Participants would wear the device for 21 days, over a 6+ hour sleep period each night.

Read the detailed description

Otis Dental proposes to develop the Otis Brux-Sensor Night Guard (OBSNG), which is a novel wireless custom night guard system with pressure sensors that can quantitatively measure bite compression forces during sleep (patent granted in June 2021). If successful, anyone suffering from Bruxism will have improved protection against the painful and damaging symptoms via a sensor-enhanced custom night guard. Dental providers can analyze and monitor bruxism compression force trends over time, thereby streamlining quality patient care through optimized treatment plans.

The technology is comprised of the Otis Custom Night Guard with an embedded electronics system that is coupled to a portion of the guard covering an axial plane of a tooth. The electronics system will be comprised of an antenna, capacitive sensor, microcontroller, and power supply. The sensor will produce and measure signals corresponding to bite compression forces generated by a wearer, over a period of time during sleep.

There are four key components to the innovation: (1) Otis Custom Night Guard. The Otis Custom Night Guard offers more comfort and protection from Bruxism compared to current products in the market (OTC and custom-made). After years of research and multiple rounds of pilot testing, Otis determined that their Custom Night Guard would be made with an equal ratio of hard co-polyester and soft polyurethane materials. In doing so, the soft inner liner would provide a level shock absorbance from jaw clenching, while the hard outer layer would provide protection against teeth grinding. It was also determined that making their custom night guards in a 2-3mm thickness, rather than the traditional 4-5mm thickness, would provide optimal comfort and user compliance. (2) Brux-Sensor. To generate the OBSNG, force-sensing resistors (FSRs) will be placed on either side of the posterior region of the Otis Custom Night Guard to collect optimal compression forces generated by jaw muscles around the Temporomandibular Joint. This sensor will allow for accurate measurements of the clenching forces applied by the patients over time. The force data can be measured at high frequencies in excess of once per second and stored in an onboard memory, allowing for a complete time-force profile for one night of usage. In the long term, an accelerometer will be integrated into the sensor to track sleep quality and jaw motion. Eventually, Otis will correlate this data to assess the patients' stress/anxiety level and establish relevant correlations with jaw forces and bruxism treatment plans. (3) Storage/Travel Case. Each OBSNG will come with a storage/travel case designed to store/protect the Otis custom night guard when not in use. The case will also act as a recharge station when not being used - enabling wireless charging and seamless data transferring to the Otis App for biofeedback. (4) Otis App. Otis will develop an app that allows patients to access personalized and regimented dental care tips and exercises that alleviate bruxism rates, dental wear and pain, headaches, shoulder tension, etc. (e.g., DIY jaw/head/ neck/shoulder massage videos). The app will also provide educational wellness information, instructional exercises to reduce stress levels and improve sleep quality (e.g., 4-7-8 breathing, meditation reminder, etc.), and discounts to partnering stress therapy apps (e.g., Noom, Headspace, Calm, etc.).

Participants will be recruited to test the OBSNG for 21 days, during 6+ hours of sleep. Upon completing the study and collecting all compression force data from each participant, the research team will begin averaging all compression force episodes throughout each of the 6+ hours of sleep per night and graph all 21 nights of averaged scores to show every participant's Bruxism pattern during the study. Upon successful build of a working prototype, the team will accomplish their first milestone by determining the bruxism severity (no/mild or mod/severe), based on the range of compression forces. The second milestone will be achieved by validating participants' bruxism severity through data points showing compression force.

Medical subject headings
Sleep Bruxism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06688474
Study groupRoleWhat they receive
Bruxism Cohort2 male participants with diagnosed Bruxism will wear the device for 21 days, over a 6+ hour sleep period each night.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Nocturnal Clenching Force (% of Maximum Voluntary Clench)

    Clenching force measured by a sensor-enhanced mouth guard and expressed as a percentage of each participant's maximum voluntary clenching force established during calibration. Force was sampled at 4 Hz during overnight wear and summarized per participant as the mean nocturnal clenching force.

    Measured: Mean of nocturnal measurements across up to 21 nights of sensor wear

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2024
  2. Study start5 Aug 2024
  3. Primary completion18 Oct 2024
  4. Study completion31 Oct 2024

Why it stopped: Enrollment was closed early due to the conclusion of the SBIR funding period; data collected from the 2 participants was sufficient for feasibility analysis.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06688474
Sponsor's protocol ID
1R43HL168988-01A1
Status last verified
Jan 2026
First submitted
8 Nov 2024
Last updated
3 Mar 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Bruxism, Sleep-Related, run by Otis Dental, LLC at 1 site in United States.

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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 3 Mar 2026. 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 United States. 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?

Yes. Results are posted in the registry (first posted 3 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Nocturnal Clenching Force (% of Maximum Voluntary Clench) (time frame: Mean of nocturnal measurements across up to 21 nights of sensor wear). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 3 Mar 2026.

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