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:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-26 @ 4:01 PM
NCT ID:
NCT06671106
Eligibility Criteria:
Inclusion Criteria:
* systemically healthy;
* eligible for oral care provision by Regional Health Service due to low socio-economic status;
* at least 16 fully erupted teeth (excluding third molars);
* diagnosed with plaque-induced gingivitis (G) or periodontal health (PH) according to the World Workshop case definitions (Trombelli et al. 2018, Chapple et al. 2018);
* willing to participate in the study and capable to fully understand and comply with the study procedures (including questionnaire reading and filling).
Exclusion Criteria:
* pregnant or lactating;
* current smoking;
* motor and/or cognitive deficit impairing compliance with the study intervals or procedures;
* legal guardian not willing to either allow for subject participation in the study or ensure adherence with the study procedures;
* teeth with developmental defects (e.g., enamel pearls/projections);
* untreated oral lesions, including dental caries or endodontic lesions;
* fixed or removable orthodontic appliances or scheduled for orthodontic therapy with a timing not compatible with the experimental phase;
* use of antibiotics in the previous 3 months;
* use of medications that affect the size of the gingival tissues, such as phenytoin, sodium valproate, certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), and immune-regulating drugs (e.g., cyclosporine);
* conditions (e.g., Sjögren's syndrome, anxiety, poorly controlled diabetes) or medications (e.g., antihistamines, decongestants, antidepressants) that are associated with hyposalivation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
14 Years
Study:
NCT06671106
Study Brief:
Protocol Section:
NCT06671106