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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT03450551
Eligibility Criteria:
Inclusion Criteria:
1. Patients aged 10-16 years of age in the late mixed/permanent dentition with Class II malocclusions (Both Cl II div 1 and Cl II div 2)
2. \> 1/2 unit Class II molar relationship bilaterally (at least 3.5mm)
3. Normal or deep overbite cases will be included
4. Skeletal Class II relationship (ANB \> 4°)
5. Overjet ≥ 5 mm in Cl II/1 cases
6. Non-extraction cases
Exclusion Criteria:
1. Children in the early mixed dentition
2. Class I and Class III malocclusions
3. Malocclusions with less than 1/2 unit II molar relationship
4. Reduced overbite / anterior openbite
5. Medically compromised patients, syndromic patients or patients with severe facial asymmetry
6. Special needs patients not able to comply with instructions / difficulty with compliance
7. Hypodontia or extracted permanent tooth (except third molars)
8. Poor oral hygiene with both Gingival bleeding Index and Plaque Index scoring no more than 1
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
16 Years
Study:
NCT03450551
Study Brief:
Protocol Section:
NCT03450551