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 @ 12:22 PM
Ignite Modification Date:
2025-12-24 @ 12:22 PM
NCT ID:
NCT04028661
Eligibility Criteria:
Inclusion Criteria:
* Females 10-13 years of age.
* Skeletal Angle Class II division 1 malocclusion with a deficient mandible. (SNB ≤ 76°)
* Horizontal or neutral growth pattern. (MMP ≤ 30°)
* Increased overjet (min 5 mm) with Class II canine relationship. (minimum of half unit)
* Cervical Vertebral Maturation (CVM) stage 3.
Exclusion Criteria:
* Systemic Disease.
* Any signs or symptoms or previous history of temporomandibular disorders (TMD) as clicking, crepitus, pain, limitation or deviation.
* Extracted or missing upper permanent tooth/teeth (except for third molars).
* Facial Asymmetry.
* Para-functional habits.
* Severe proclination or crowding that requires extractions in the lower arch.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
10 Years
Maximum Age:
13 Years
Study:
NCT04028661
Study Brief:
Protocol Section:
NCT04028661