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:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT03160560
Eligibility Criteria:
Inclusion Criteria:
* Completion of the Informed Consent.
* Must be able to follow verbal/written instructions.
* Between 21 to 65 years of age, male or female.
* Has normal oral interior cheek wall tissues.
* In good general health.
* Should not have any severe or debilitating disease that may impede participation.
* Average organoleptic intensity rating of at \>2.6 but \<4.5 on an intensity scale of 0-5.
Exclusion Criteria:
* Pregnant or nursing.
* Diagnosis of Xerostomia, including medication induced Xerostomia.
* Oral or extraoral piercing that interferes with the clinical assessments in the mouth.
* Fixed or removable oral appliance.
* Advanced periodontal disease or excessive gingival recession.
* Known allergy or sensitivity to study products.
* Unwilling to abstain from all oral hygiene products other than those prescribed for the study.
* Heavy deposits of calculus, either supragingival and/or subgingival.
* History of severe transmittable infectious disease e.g. hepatitis, HIV, tuberculosis.
* Medical or dental condition that would be unduly affected by participation in this study.
* Any other condition that may interfere with the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT03160560
Study Brief:
Protocol Section:
NCT03160560