The purpose of this Study is to assess the efficacy of two ClōSYS Oral Rinse products in human subjects in controlling oral malodor in partial fulfillment of the requirements for American Dental Association's (ADA) requirement for obtaining ADA Seal for malodor.
Who can participate
Age range
21 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Malodor as Measured by Organoleptic Score
Timeframe: At baseline and weekly for 3 weeks for each condition and cross-over