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 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT06140758
Eligibility Criteria:
Inclusion Criteria:
* Be 18-75 years of age.
* Provide written informed consent prior to participation and be given a signed copy of the informed consent form.
* Be in good general health based on medical/dental history and oral exam.
* Have no history of adverse or allergic reactions to tin or tin-containing products.
* Agree not to participate in any other oral study for the study duration.
* Have a reasonable functional dentition as determined by the oral examiner and sufficient teeth to support the fabricated dental appliance.
* Be willing to participate in the study, able to follow the study directions, successfully tolerate/perform all study procedures, and willing to return for all specified visits at their appointed time.
* Be willing to refrain from using non-study dentifrice, mouth rinse, chewing gum, and other non-study oral care products during the study.
* Be willing to postpone all elective dental procedures until the study has been completed.
* Be willing to refrain from using calcium chews while using the test products.
* Be willing and able to refrain from wearing a nightguard (occlusal splint) for the entire course of the study (for nightguard wearers only).
* Ability to understand, and ability to read and sign, the informed consent form.
* Have at least 22 natural teeth.
* Have a gum-stimulated whole salivary flow rate ≥ 1.0 ml/minute and unstimulated whole salivary flow rate ≥ 0.2 ml/minute.
Exclusion Criteria:
\-
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06140758
Study Brief:
Protocol Section:
NCT06140758