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:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT03100435
Eligibility Criteria:
Inclusion Criteria:
* Presence of enough teeth to support the mouth guard.
* Subjects diagnosed with clinical health, gingivitis, or slight chronic periodontitis defined as periodontal inflammation with slight (1-2mm) attachment loss.
Exclusion Criteria:
* Subjects with insufficient dental support for the mouth guard
* Subjects diagnosed with moderate or severe chronic periodontitis.
* Subjects with known allergy to acrylic or titanium.
* Subjects who smoke cigarettes, cigars, snuff tobacco, or any other form of smoking.
* Subjects with a history of antibiotic treatment within the last six months.
* Subjects with contraindications to wearing a mouth guard, such as chronic obstructive pulmonary disease or severe sleep apnea.
* Subjects with uncontrolled or debilitating medical conditions, including but not limited to subjects with uncontrolled diabetes, hematologic disorders, cancers, immunosuppression, severe cardiovascular disease, or uncontrolled thyroid disease
* Subjects that are currently pregnant according to self-report
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03100435
Study Brief:
Protocol Section:
NCT03100435