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A randomized controlled trial design on the efficacy of mixed support combined tongue position guidance aligners and traditional aligners in the treatment of maxillary arch constriction with weak tongue elevation

A Preliminary Study on the Skeletal Expansion Effect of Aligner in Mixed Dentition Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106533
Enrollment
Unknown
Registered
2025-07-25
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Malocclusion

Interventions

Test group:Clear Aligners with Mixed Support Expansion Lingual Guidance
Control group:Traditional Clear aligners

Sponsors

Children's Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: Pediatric patients aged 6-12 years in the mixed dentition period, diagnosed with maxillary arch constriction and presenting with low tongue position. No symptoms and signs of upper airway obstruction, temporomandibular joint disorder, or a history of systemic diseases.

Exclusion criteria

Exclusion criteria: History of previous orthodontic treatment, presence of severe craniofacial deformity, significant respiratory obstruction symptoms, symptoms of temporomandibular joint disorder, and presence of systemic diseases affecting tongue muscle.

Design outcomes

Secondary

MeasureTime frame
Airway;Cephalometric indices;Soft tissue indices;—

Primary

MeasureTime frame
Arch Width;Bone Width;Tongue Position;Hyoid bone position;Tongue Pressure;Visual Analogue Scale;—

Countries

China

Contacts

Public ContactLi Xuan

Children's Hospital of Fudan University

lixuan_kq@fudan.edu.cn+86 136 3638 2429

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026