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 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
NCT ID:
NCT06300866
Eligibility Criteria:
Inclusion Criteria:
* Potential subjects must meet all of the following criteria
* Subjects, ages 18-70, inclusive
* Availability for the six-month duration of the clinical research study
* Good general health
* Initial gingivitis index of at least 1.0 as determined by the use of the Loe-Silness Gingival Index
* Initial plaque index of at least 1.5 as determined by the use of the Quigley-Hein Plaque Index
* Signed Informed Consent Form
Exclusion Criteria:
* Presence of orthodontic appliances
* Presence of partial removable dentures
* Tumor(s) of the soft or hard tissues of the oral cavity
* Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study
* Five or more carious lesions requiring immediate restorative treatment
* Antibiotic use any time during the one-month period prior to entry into the study -Participation in any other clinical study or test panel within the one month prior to entry into the study
* Dental prophylaxis during the past two weeks prior to baseline examinations
* History of allergies to oral care/personal care consumer products or their ingredients -On any prescription medicines that might interfere with the study outcome
* An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours
* History of alcohol and/or drug abuse
* Self-reported pregnancy and/or lactating subjects.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06300866
Study Brief:
Protocol Section:
NCT06300866