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 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 1:24 AM
NCT ID:
NCT05330793
Eligibility Criteria:
Inclusion Criteria:
* Ages 18 to 65 years old
* Fluent in English
* Have mild to moderate gingivitis (i.e., probing depth between 3mm and 5mm)
* Bleeding on probing on 30%+ areas
* Able to perform oral hygiene adequately after formal instructions
* Able to understand and comply with study procedure
* Able to provide written informed consent
* Able to come to Roseman Dental Clinics in South Jordan for a 90-minute pre-screening to determine eligibility
* Able to complete five (90-minute) clinic visits in 2-week intervals
Exclusion Criteria:
* • Probing depths less than 3mm
* Breastfeeding, pregnant or trying to become pregnant
* Currently taking or have taken any of the following within 30 days of enrollment:
* Oral probiotics
* Antibiotic medications
* Antifungal medications (e.g., nystatin, clotrimazole, ketoconazole, griseofulvin)
* Antiseptic medications
* Immunosuppressant and/or chemotherapeutic medications
* Medications that could affect gum response measurement (e.g., calcium channel blockers, cyclosporin, anti-seizures like phenytoin and related drugs, anti-inflammatory agents)
* Frequent alcohol consumption (\> 2 drinks per day, or \> 8 per week for women, or \> 15 per week for men)
* Use of marijuana (which can cause dry mouth or other conditions) or recreational drugs
* Use of tobacco products including chewing tobacco and all types of cigarettes (e-cigarettes)
* Known allergy to any product ingredient (ingredient list provided by USANA)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05330793
Study Brief:
Protocol Section:
NCT05330793