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 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT06048627
Eligibility Criteria:
Inclusion Criteria:
* Availability for the six-month duration of the clinical research study.
* Good general health.
* Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
* Initial gingivitis index of at least 1.5 as determined by the use of the Gingival Index (Löe 1967).
* Initial plaque index of at least 1.5 as determined by the use of the Plaque Index (Turesky et al. 1970).
* Signed Informed Consent Form.
Exclusion Criteria:
* Presence of orthodontic bands.
* Malign tumor(s) of the soft or hard tissues of the oral cavity.
* 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 or drinking for periods up to 4 hours.
* History of alcohol or drug abuse.
* Self-reported pregnant or lactating subjects.
* Participants who have systemic diseases that require regular systemic medication intake that may affect the gingival condition (e.g. antibiotics, phenytoin, nifedipine, cyclosporine, steroids, antiphlogistics).
* Participants who require antibiotic treatments for dental appointments.
* Participants with current moderate or severe chronic or aggressive periodontitis (periodontitis screening index \[PSI\] \>2 in more than 2 sextants or PSI \>3).
* Subjects with caries requiring treatment (e.g., caries with cavity) or other oral diseases (including gingival hyperplasia, diseases of the oral mucosa);
* Smokers or/and users of tobacco products.
* Persons, who are unable to give their consent (e.g., persons who have limited legal capacity)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06048627
Study Brief:
Protocol Section:
NCT06048627