OstiSense Biosensor in Bruxism Reduction - A Clinical Study

March 21, 2022 updated by: University of California, San Francisco
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Pilot Study:

30 subjects will be recruited for this pilot study. An oral exam will be performed to check for gingiva and tooth conditions as well as fulfilling inclusion and exclusion criteria as described below. Subjects will be randomly assigned to an active treatment or a control group. OstiSense biosensor feed back tool (night guards) will be delivered to the participant. First patient impressions about wearing comfort will be evaluated, chair side. Then the investigators will test the efficiency of the OstiSense biosensor feedback tool in reduction of numbers of bruxism episodes and reduction of the duration of bruxism episodes (primary outcome). These data will be collected also in order to achieve information for a sample size calculation for a larger subsequent clinical trial. The investigators will collect information about self-reported (or reported by sleeping partners in SB) reduced frequency of bruxism episodes. In addition, self-reported reduction in pain (facial pain, myofascial headache) (secondary outcome) is of interest. Visual pain scales and pain questionnaires will be used as validated instruments for subjective pain assessment.

Active Treatment Group:

Participants will be instructed to wear the biofeedback tool during the night/sleep. They will wear the biofeedback tool for 1 week with biofeedback turned off to record baseline activity. At the 1-week recall, the investigators will check for any comfort issues and will confirm accurate data recording. For 3 more weeks the biofeedback will stay turned off to collect further baseline data.

At the next recall (4-week recall) participants will be interviewed about any wear issues and will be asked to fill out the same questionnaire as used in phase 1 of the pilot study. The biofeedback mechanism will then be turned on (battery insertion). During this meeting subjects will be instructed to test the vibration mechanism by increasing their bite force until vibration occurs, and then to relax their muscles so that vibration stops. Subjects will be asked to repeat this procedure several times to get familiar with the active device and also to learn to relax their muscles when the feedback occurs during night bruxism..

Participants will wear the tool with biofeedback turned on during the night/sleep for 8 more weeks. They will be asked to return for a check after the first week (5-week recall) of the 8 weeks to identify any wear issues while the tool is turned on, and for checking the data recording function. At the end of 8 weeks, participants will be invited for a final recall visit 12-week recall). The same questionnaire will be provided, and feedback questions will be asked. All data about bruxism episodes will be collected from the smart device.

Control Group:

Participants in the control group will be treated, asked for feedback and receive questionnaires identical to the subjects in the active treatment group. The only difference will be that the biofeedback mechanism in the biofeedback night guard tool will always stay turned off. At the 1-week recall the investigators will check for any comfort issues and will confirm accurate data recording. After three weeks the investigators will again check on the participant, will identify any wear issues, ask for feedback and will check the data recording function (4-week recall). At the end of additional 8 weeks participants will be invited for a final recall visit (12-week recall). The questionnaire will be provided, and feedback questions will be asked. Data from the smart device about bruxism episodes will be collected.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • UCSF School of Dentistry - Dental Offices in Bay Area

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 18 to 65 years, in good general health
  • the occlusion is stable with at least 8 lower teeth (including several lower front teeth)
  • willing to comply with all study procedures and protocols
  • must be able to read and understand English
  • have an understanding of the study
  • able to provide written informed consent in English
  • willing to sign the "Authorization for Release of Personal Health Information and Use of Personally Unidentified Study Data for Research" form; data will only be used for research.

Exclusion Criteria:

  • having acute temporo mandibular joint pain or a history of acute temporo mandibular joint pain
  • having used a biofeedback tool for bruxism reduction before
  • subjects not having a smart phone device
  • subjects not willing to use their smart phone device for data collection related to their bruxism
  • heavily crowed lower teeth (difficult to integrate a night guard)
  • wearing complete dentures
  • show evidence of extremely poor oral hygiene
  • subjects at extreme high caries risk
  • subjects with pacemakers
  • subjects suffering from systemic diseases, significant past or medical history with conditions that may affect oral health or oral flora (i.e. diabetes, HIV, heart conditions that require antibiotic prophylaxis),
  • taking medications that may affect the oral flora or salivary flow (e.g. antibiotic use in the past three months, drugs associated with dry mouth / xerostomia [extreme high caries risk])
  • other conditions that may decrease the likelihood of adhering to study protocol
  • subjects who will leave the area and are unable to complete the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OstiSense biosensor - active
Participants will wear the biofeedback tool for 1 week with biofeedback turned off. After checking, for 3 more weeks the biofeedback will stay turned off. At 4-week recall the biofeedback mechanism will be turned on. Subjects will be instructed how to use the vibration mechanism. Participants will wear the tool with biofeedback turned on during the night/sleep for 8 more weeks. They will be asked to return for a check after the first week with biosensor turned on (5-week recall). At the end of 8 weeks, participants will be invited for a final recall visit (12-week recall). At points a questionnaire will be provided, and feedback questions will be asked. All data about bruxism episodes will be collected from the smart device.
Device: OstiSense biosensor - active
The activated biofeedback back night guard will be used to reduce sleep bruxism
Placebo Comparator: OstiSensor biosensor - not activated
Participants in the control group will be treated, asked for feedback and receive questionnaires identical to the subjects in the active treatment group. The only difference will be that the biofeedback mechanism in the biofeedback night guard tool will always stay turned off. At the 1-week recall a check for any comfort issues will occur and accurate data recording will be confirmed. After three weeks the participant will be checked on, feedback will be requested and any wear issues will be identified, and the data recording function will be checked (4-week recall). At the end of additional 8 weeks participants will be invited for a final recall visit (12-week recall). A questionnaire will be provided, and feedback questions will be asked, data from the smart device about bruxism episodes will be collected.
Device: OstiSensor biosensor - not activated
A not-activated night guard will be used as control device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in frequency of bruxism episodes
Time Frame: 8 weeks
Evaluating how efficient the OstiSense biosensor tool is in changing the number of bruxism episodes
8 weeks
Change in duration of bruxism episodes
Time Frame: 8 weeks
Evaluating how efficient the OstiSense biosensor tool is in changing the duration of bruxism episodes
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported change in frequency of bruxism episodes
Time Frame: 8 weeks
Self-reported (or reported by sleeping partners in SB) change in frequency of bruxism episodes
8 weeks
Self-reported change in pain - change in pain level marked on a visual pain scale
Time Frame: 8 weeks
Self-reported change in pain (facial pain, myofascial headache) assessed using a visual pain scale with 6 different pain levels indicated by 6 different smileys (from happy smiling to crying) and a pain severity scale from 0 to 10, which includes the smiley faces, with 0 as no pain, 1-2 slight pain, 3-4 mild, 5-6 moderate, 7-8 severe and 9-10 horrible pain
8 weeks
Self-reported change in pain - change in yes/no answers on a pain questionnaire
Time Frame: 8 weeks
Self-reported change in pain (facial pain, myofascial headache) using a pain questionnaires requiring yes and no answers to questions
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Peter Rechmann, DMD, PhD, UCSF School of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

November 12, 2018

First Submitted That Met QC Criteria

November 19, 2018

First Posted (Actual)

November 21, 2018

Study Record Updates

Last Update Posted (Actual)

April 1, 2022

Last Update Submitted That Met QC Criteria

March 21, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P0533276

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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