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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT04760535
Eligibility Criteria:
Inclusion Criteria:
* patients who have been diagnosed with transverse maxillary deficiency;
* mixed dentition phase with cervical vertebral maturation stage (CVMS) less than 4;
* fully erupted upper and lower first molars;
* transversal discrepancy ≤5mm
* demonstration of a good standard of oral hygiene (determined through questioning and clinical examination);
* subjects willing to consent to the trial and comply with the trial regime.
Exclusion Criteria:
* any general medical health problems which may influence gingival health, such as those necessitating antibiotic cover as bacteremia prophylaxis, diabetes mellitus, epilepsy, or physical or mental disability;
* permanent teeth extraction-based treatment (third molars excluded);
* morphologic crown anomalies;
* auxiliary treatment during arch expansion stage (such as crossbite elastics);
* posterior interproximal reduction;
* orthognathic surgery treatment planned;
* cleft palate or severe facial deformities.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
10 Years
Study:
NCT04760535
Study Brief:
Protocol Section:
NCT04760535