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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT05989750
Eligibility Criteria:
Inclusion Criteria:
* Subjects about to undergo fixed orthodontic treatment will be invited to participate.
* Age between 12 and 16 years only participants
* Informed written consent obtained by the parents
Exclusion Criteria:
* Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
* Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation
* Previous enrolment into the current investigation
* Enrolment of the PI, his/her family members, employees and other dependent persons
* History of fixed orthodontic treatment
* Defects on enamel on labial surfaces of the teeth
* Untreated cavitated lesions
* Plaque levels \>25%
* Periodontitis
* Multiple missing teeth
* Cleft lip and/or palate or other craniofacial anomalies or syndromes
* Patients taking any regular medication
* Patients with asthmatic problems
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
16 Years
Study:
NCT05989750
Study Brief:
Protocol Section:
NCT05989750