OstiSense Biosensor in Bruxism Reduction - A Clinical Study
Bruxism, Sleep
About this trial
This is an interventional treatment trial for Bruxism, Sleep focused on measuring night guard, biofeedback, biosensor
Eligibility Criteria
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
Sites / Locations
- UCSF School of Dentistry - Dental Offices in Bay Area
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
OstiSense biosensor - active
OstiSensor biosensor - not activated
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.
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.