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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT07217756
Eligibility Criteria:
Inclusion Criteria:
* adolescents (12-17 years old);
* patients scheduled to undergo comprehensive fixed orthodontic therapy (OT) (for at least 6 months with metal braces/wires) on both dental arches;
* patients with increased BMI (≥25.0 Kg/m2) (test-Group);
* patients with normal BMI \[18.5-24.99 (Kg/m2)\] (control-Group);
* patients with all 6 mandibular anterior teeth present and mild-to-moderate mandibular crowding (\<7.5 mm);
* patients and parents/guardians willing to provide signed assent/permission.
Exclusion Criteria:
* self-reported habitual tobacco product users;
* patients with self-reported medical diseases such as hepatic diseases, blood disorders, cardiovascular diseases, HIV, diabetes mellitus, and viral infections;
* patients with craniofacial syndromes and/or cleft lip and palate;
* pregnant and/or lactating females (by self/parent report);
* edentulous individuals;
* patients with active or a history of periodontitis;
* patients having undergone surgical and/or non-surgical periodontal therapy within the past 6 months;
* patients with physical and/or mental/cognitive disabilities who are decisionally-impaired and not able to consent/assent for themselves;
* patients who reported use of medications such as antibiotics, steroids (inhalers and/or pills), non-steroidal anti-inflammatory drugs, and antimicrobial mouth-rinses within the past 3 months or those who require prophylactic antibiotics prior to dental procedures;
* patients undergoing cancer therapy;
* underweight patients (BMI less than 18.5 Kg/m2);
* patients with oral mucosal lesions such as median rhomboid glossitis and lichen planus;
* patients with clinically visible carious teeth.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT07217756
Study Brief:
Protocol Section:
NCT07217756