Study 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.
A Sensor-enhanced Mouth Guard to Quantitatively Measure Bite Compression Forces.
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
1 other identifier
observational
2
1 country
1
Brief 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.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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2024
Shorter than P25 for all trials
1 active site
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
Study Start
First participant enrolled
August 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2024
CompletedFirst Submitted
Initial submission to the registry
November 8, 2024
CompletedFirst Posted
Study publicly available on registry
November 14, 2024
CompletedResults Posted
Study results publicly available
March 3, 2026
CompletedMarch 3, 2026
January 1, 2026
2 months
November 8, 2024
January 5, 2026
February 11, 2026
Conditions
Outcome Measures
Primary Outcomes (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.
Mean of nocturnal measurements across up to 21 nights of sensor wear
Study Arms (1)
Bruxism Cohort
2 male participants with diagnosed Bruxism will wear the device for 21 days, over a 6+ hour sleep period each night.
Eligibility Criteria
US participants only.
You may qualify if:
- years of age
- male and/or female
- healthy with exception to being diagnosed with Bruxism.
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Otis Dental, LLClead
Study Sites (1)
Otis Dental
San Francisco, California, 94118, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Andrew Lee
- Organization
- Otis Dental, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2024
First Posted
November 14, 2024
Study Start
August 5, 2024
Primary Completion
October 18, 2024
Study Completion
October 31, 2024
Last Updated
March 3, 2026
Results First Posted
March 3, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share