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 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT05539469
Eligibility Criteria:
Inclusion Criteria:
* patients and their parents are able or willing to give informed consent;
* patients who will begin orthopedic treatment with RME cemented on first maxillary molars and with welded vestibular tubes;
* patients undergone no previous orthopedic/orthodontic treatment;
* parents' willing to download and use Ortodontika application;
* parents possessing an Apple or Android smartphone with iOS ≥ 10.0 or Android ≥ 4.4 versions;
* smartphone provided with an internet connection.
Exclusion Criteria:
* no sectional wire appliances in the upper arches;
* no need of additional orthopedic/orthodontic appliances, also in the lower arch;
* no vestibular welded protraction hooks on RME;
* patients taking regular medications for systemic diseases that could alter periodontal conditions and pain perception (antibiotics, antibacterial mouth rinses, NSAIDS, steroids);
* siblings with previous orthopedic treatment with RME;
* parents and patients with low compliance.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
14 Years
Study:
NCT05539469
Study Brief:
Protocol Section:
NCT05539469