Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT03749928
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03749928
Study Brief:
Protocol Section:
NCT03749928