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NCT06688474

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

Terminated Results posted Last updated 3 March 2026
What this trial tests

trial in Bruxism, Sleep-Related in 2 participants. Terminated before completion.

Timeline
5 August 2024
Primary endpoint
18 October 2024
31 October 2024

Quick facts

Lead sponsorOtis Dental, LLC
StatusTerminated
Study typeOBSERVATIONAL
Enrollment2
Start date5 August 2024
Primary completion18 October 2024
Estimated completion31 October 2024
Sites1 location across United States

Conditions studied

Sponsor

Otis Dental, LLC

Who can join

Adults 18 to 50, male only, with Bruxism, Sleep-Related. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Nocturnal Clenching Force (% of Maximum Voluntary Clench) Primary · Mean of nocturnal measurements across up to 21 nights of sensor wear

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.

GroupValue95% CI
Bruxism Cohort.87± 4.81

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06688474.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing