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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT04216069
Eligibility Criteria:
Inclusion Criteria:
* Good general health;
* Age 12 to 17;
* Absence of motor, comprehension and cognitive difficulties that impede adequate oral hygiene.
Exclusion Criteria:
* Active dental caries with cavity exposing dentin (visible cavity) on teeth for which the simplified oral hygiene index will be used. If these teeth are not present, adjacent teeth may be considered;
* Teeth with formation defects and dental crowding;
* Periodontal disease (tooth mobility \> 2 mm, pocket \> 5 mm, gingivitis);
* Parafunctional habits (bruxism, nail biting), active clamps for removable partial dentures, use of orthodontic appliance;
* Volunteer or legal guardian who does not agree with the terms of the study or has difficulty appearing for the follow up appointments;
* Pregnant volunteers;
* Use of medications that alter gingival health, such as antibiotics, in the previous three months;
* Use of mouthwash or toothpaste containing products for the control of biofilm;
* Smokers;
* Systemic disease (diabetes).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT04216069
Study Brief:
Protocol Section:
NCT04216069