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:
NCT06735235
Eligibility Criteria:
Inclusion Criteria:
* Be at least 18 years of age;
* Provide written informed consent prior to study participation and be given a signed copy of the Informed Consent form;
* Be in good general health as determined by the Investigator/Designee based on a review of their medical history;
* Have at least 16 natural teeth;
* Have normal salivary flow (0.3-0.6 ml/min) or deemed acceptable by the Investigator/Designee as determined in a previous screening outside of this protocol;
* Agree not to participate in any other oral care studies for the duration of this study;
* Agree not to change their current oral care routine except 1) to refrain from using mouth rinse and 2) to agree to use study washout product as designated (current floss users are permitted to continue to floss during this study); viii. Agree to delay elective dentistry, including dental prophylaxis, until study completion, and to report any non-study dentistry received during the course of the study;
* Agree to refrain from eating, using breath mints, using medicated lozenges, chewing gum, brushing their teeth or drinking within 2 hours of the visit, other than small sips of water up to 30 minutes prior to the visit;
* Agree to refrain from drinking tea or mineral water, and/or eating sardines within the 12 hours prior to the study visit; and
* Agree to return for all scheduled visits and to follow all study procedures.
Exclusion Criteria:
* Active treatment for gingivitis, periodontitis, or caries;
* Self-reported pregnancy or nursing;
* Smoking or tobacco chewing;
* Sjögren syndrome or any other disease/condition causing severe xerostomia;
* Kidney disease or renal impairment;
* Undergoing chemotherapy or irradiation procedures;
* Fixed orthodontic appliances that may interfere with product use;
* Inability to undergo any study procedures; or
* Any condition or disease, as determined by the Investigator/Designee that could be expected to interfere with examination procedures or with the subject's safe completion of the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06735235
Study Brief:
Protocol Section:
NCT06735235