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:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT06944860
Eligibility Criteria:
Inclusion Criteria:
1. Patients with Class II Division 1 incisor relationship
2. Overjet of ≥ 7mm
3. Age range of children: 10-12 years in females, 12-14 years in males
4. All permanent incisors and molars erupted
5. ICDAS ≥ score 3 and BPE ≥ 3
6. Able to understand English or Bahasa Melayu
Exclusion Criteria:
1. Patients with craniofacial syndromes (example: cleft lip and palate)
2. Patients with previous history of orthodontic treatment
3. Patients with hyperdivergent facial type (MMPA \> 40º)
4. Untreated gingival disease (e.g.: gingivitis, periodontitis)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
14 Years
Study:
NCT06944860
Study Brief:
Protocol Section:
NCT06944860