OstiSense Biosensor in Bruxism Reduction - A Clinical Study
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/6/2019 |
| Start Date: | June 2019 |
| End Date: | June 2020 |
| Contact: | Peter Rechmann, DMD, PhD |
| Email: | Peter.Rechmann@ucsf.edu |
| Phone: | 415 514 3225 |
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.
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.
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.
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.
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
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