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 @ 1:28 PM
Ignite Modification Date:
2025-12-24 @ 1:28 PM
NCT ID:
NCT01853995
Eligibility Criteria:
Inclusion Criteria:
* Cl II/1 malocclusion with an overjet greater than 4 mm.
* Mild to moderate Class II Skeletal pattern (A-N-B \> 4°) with retrognathic mandible (S-N-B \< 76°).
* Growth potential. Fishman skeletal maturation indicator (SMI) method was used to assess the hand-wrist radiographs, and only patients in the peak of the pubertal growth spurt, which occurs on average between SMIs 4 to 7, at the beginning of the treatment/observation period were invited.
Exclusion Criteria:
* craniofacial syndromes
* clinically obvious facial asymmetry
* extreme vertical disproportion
* prior orthodontic therapy
* permanent tooth extractions
* significant medical history
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
11 Years
Maximum Age:
16 Years
Study:
NCT01853995
Study Brief:
Protocol Section:
NCT01853995