Prospective Non-Randomized Controlled Clinical Study on Early Orthodontic Treatment of Skeletal Malocclusion in Adolescents

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600127964

Enrollment

Unknown

Registered

2026-07-10

Start date

2026-07-20

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skeletal Malocclusion

Interventions

Intervention group :Early corrective treatment was initiated immediately after enrollment and lasted for approximately one year, followed by long-term follow-up

Control group:Orthodontic/orthopedic treatment was not carried out in the first 12 months after baseline, and only follow-up observations were conducted as planned. Orthodontic treatment was initiated

Eligibility

Sex/Gender

All

Age

7 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 7 to 12 years old (inclusive), with no restriction on gender. 2. Diagnosed with skeletal malocclusion through clinical examination and cephalometric measurement (ANB 4.7°). 3. No prior history of orthodontic treatment. 4. Absence of underlying systemic diseases, such as hypertension, diabetes, heart disease, and immune disorders. 5. Both the children and their legal guardians voluntarily participated in this study and signed informed consent forms.

Exclusion criteria

Exclusion criteria: 1. Patients with facial asymmetry. 2. Patients with hereditary or systemic diseases (e.g., rheumatoid arthritis) that affect jaw growth. 3. Patients with severe periodontal disease or temporomandibular joint disorders (including pain, clicking sound, and mouth opening limitation). 4. Patients with allergies to experimental materials (such as resin). 5. Patients who planned to move out of the local area during the study period and could not complete follow-up.

Design outcomes

Primary

Measure	Time frame
Growth of the maxilla and mandible;	—

Secondary

Measure	Time frame
Total Growth Increment of Maxilla and Mandible;Changes of Upper Airway Volume;Assessment of Mental Health and Behavioral Status;General Physical Growth and Development Assessment;	—

Countries

China

Contacts

Public ContactFang Bing

Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine

fangbing@sjtu.edu.cn+86 188 0135 1666

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026