Status:
WITHDRAWN
OstiSense Biosensor in Bruxism Reduction - A Clinical Study
Lead Sponsor:
University of California, San Francisco
Conditions:
Bruxism, Sleep
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ev...
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 des...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03749928
Start Date
December 1 2021
End Date
December 1 2022
Last Update
April 1 2022
Active Locations (1)
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1
UCSF School of Dentistry - Dental Offices in Bay Area
San Francisco, California, United States, 94143