OstiSense Biosensor in Bruxism Reduction - A Clinical Study

NCT03749928 | Withdrawn FDA Device

• 1 other identifier: P0533276
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

night guard; biofeedback; biosensor

Outcome Measures

Primary Outcomes (2)

• Change in frequency of bruxism episodes

  Evaluating how efficient the OstiSense biosensor tool is in changing the number of bruxism episodes

  8 weeks

• Change in duration of bruxism episodes

  Evaluating how efficient the OstiSense biosensor tool is in changing the duration of bruxism episodes

  8 weeks

Secondary Outcomes (3)

• Self-reported change in frequency of bruxism episodes

  8 weeks

• Self-reported change in pain - change in pain level marked on a visual pain scale

  8 weeks

• Self-reported change in pain - change in yes/no answers on a pain questionnaire

  8 weeks

Study Arms (2)

OstiSense biosensor - active

EXPERIMENTAL

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

OstiSensor biosensor - not activated

PLACEBO COMPARATOR

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

Interventions

OstiSense biosensor - active DEVICE

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

OstiSense biosensor - active

OstiSensor biosensor - not activated DEVICE

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

OstiSensor biosensor - not activated

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF School of Dentistry - Dental Offices in Bay Area

San Francisco, California, 94143, United States

Location

Related Publications (23)

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MeSH Terms

Conditions

Sleep Bruxism

Condition Hierarchy (Ancestors)

Bruxism; Tooth Diseases; Stomatognathic Diseases; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Peter Rechmann, DMD, PhD

  UCSF School of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 21, 2018
• Study Start: December 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)