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OstiSense Biosensor in Bruxism Reduction - A Clinical Study

NCT03749928 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-04-01

No results posted yet for this study

Summary

The overall objective of the clinical studies with the OstiSense biosensor tool will be to evaluate whether the use of the OstiSense biosensor tool significantly reduces the number of sleep bruxism events per night as well as the duration of those events for patients with bruxism.The product under investigation is the OstiSense biosensor with biofeedback for bruxism therapy. The sensor is integrated in a night-guard like device and registers the pressure created during a bruxism episode. If a predetermined pressure threshold is exceeded, the integrated vibration tool will be activated, and the vibrations will/should remind the wearer to stop clenching his jaws and relax his facial muscles. Due to this feedback, the number of bruxism episodes as well as clenching time per episode should be reduced. The sensor also identifies the time of grinding and the sleep stage of the patient.

Conditions

  • Bruxism, Sleep

Interventions

DEVICE

OstiSense biosensor - active

The activated biofeedback back night guard will be used to reduce sleep bruxism

DEVICE

OstiSensor biosensor - not activated

A not-activated night guard will be used as control device

Sponsors & Collaborators

Principal Investigators

  • Peter Rechmann, DMD, PhD · UCSF School of Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2022-09-30
Completion
2022-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03749928 on ClinicalTrials.gov