Trial Outcomes & Findings for A Sensor-enhanced Mouth Guard to Quantitatively Measure Bite Compression Forces. (NCT NCT06688474)

Last Updated: 2026-03-03

Results Overview

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.

Recruitment status

TERMINATED

Target enrollment

2 participants

Primary outcome timeframe

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

Results posted on

2026-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	Bruxism Cohort Participants with diagnosed Bruxism will wear the device for 21 days, over a 6+ hour sleep period each night.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bruxism Cohort n=2 Participants 2 male participants with diagnosed Bruxism will wear the device for 21 days, over a 6+ hour sleep period each night.
Age, Categorical <=18 years	0 Participants n=41 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=41 Participants
Age, Categorical >=65 years	0 Participants n=41 Participants
Age, Continuous	40 Years n=41 Participants
Sex: Female, Male Female	0 Participants n=41 Participants
Sex: Female, Male Male	2 Participants n=41 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=41 Participants
Race (NIH/OMB) Asian	1 Participants n=41 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants
Race (NIH/OMB) Black or African American	0 Participants n=41 Participants
Race (NIH/OMB) White	1 Participants n=41 Participants
Race (NIH/OMB) More than one race	0 Participants n=41 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants
Region of Enrollment United States	2 participants n=41 Participants
Mean clenching force at baseline (% of maximum voluntary clench)	NA percentage of maximum voluntary clench n=41 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Bruxism Cohort n=2 Participants Participants with diagnosed bruxism wore the sensor-enhanced mouth guard for up to 21 nights, with at least 6 hours of overnight use per night.
Mean Nocturnal Clenching Force (% of Maximum Voluntary Clench)	.87 Percent of maximum voluntary clench (%MV Standard Deviation 4.81

Adverse Events

Bruxism Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrew Lee

Otis Dental, Inc

Phone: 4157062520

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place