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 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT06366568
Eligibility Criteria:
Inclusion Criteria:
* You must provide consent to participate by signing this informed consent form.
* Available for the two(2) week study duration.
* You must be at least eighteen(18) years old and not older than seventy(70) years of age.
* You must not smoke.
* You must be in good general health for participation in the study, based on the opinion of the study investigator.
* You must have at least 20 natural permanent teeth.
* Your teeth must meet the scoring entry criteria for dental plaque and gingivitis(gum inflammation) at the discretion of the study examiner.
* You must meet the scoring criteria for gum discomfort, determined using your responses to the survey questionnaire.
* You must have no known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the study examiner.
Exclusion Criteria:
* Medical condition which requires premedication prior to dental visits/procedures.
* Presence of fix/ removable prosthodontics dentures that may interfere with this study clinical examinations.
* Advanced periodontal disease (gum disease) and/or treatment for periodontal disease (including surgery) within the past twelve months.
* Five (5) or more decayed, untreated dental sites (cavities) and/or any dental condition requiring urgent dental care.
Abnormalities/diseases of the soft or hard oral tissues.
* Orthodontic appliances/bands/lingual bars that interfere with any clinical assessment (plaque scoring)
* Current smokers and/or tobacco users and/or a history of alcohol or drug abuse.
* Use of drugs that can affect salivary flow.
* Use of antibiotics one (1) month prior to study entry and/or during participation in this study.
* Use of any over the counter medications other than analgesics that could interfere with the study at PI discretion.
* Self-reported pregnancy and/or breastfeeding.
* Current Participation in another clinical study or during the month prior to this clinical study entry.
* Known allergies and/or reactions to common dentifrice ingredients.
* Medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits.
* Immunocompromised conditions (AIDS, immunosuppressive drug therapy).
* Infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06366568
Study Brief:
Protocol Section:
NCT06366568