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A randomized controlled trial for a new Twin-block appliance in guiding dento-maxillofacial growth in children with hyperdivergent malocclusion

A randomized controlled trial for a new Twin-block appliance in guiding dento-maxillofacial growth in children with hyperdivergent malocclusion

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035882
Enrollment
Unknown
Registered
2020-08-19
Start date
2022-01-01
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Skeletal Class II hyperdivegent malocclusion

Interventions

Test group:LLTB appliance
Control group:TB appliance

Sponsors

Shanghai Stomatological Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
9 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Aged 9-14 years, no gender limit; 2. Protrusion deformity, poor chin morphology, mandibular retrusion, ANB > 5 degree, maxillary development is basically normal; 3. Children with long-face growth pattern, 35 degree < SN-MP < 45 degree; (Ethical considerations: children treated with traditional twin-block appliances are prone to elongation of the posterior teeth, causing the backward and downward rotation of mandibular. The increase in face height will aggravate the original long face and bring ethical issues; therefore, the subjects included in this study are children with high mandibular plane angle, and the SN-MP is controlled within 45 degree, these children show a tendency of long-face growth pattern, but have not yet developed into severe long face. Even if the face height increase after treatment of traditional twin-block appliances, it is still acceptable.) 4. The upper airway is narrow; 5. Subjects had good compliance and were able to wear appliances as required and rechecked regularly.

Exclusion criteria

Exclusion criteria: 1. Children who have passed pubertal peak according to the modified cervical spine analysis method (Cvs4 stage); 2. Children have symptoms of temporomandibular joint disorders; 3. Children with loose deciduous molar; 4. Patients with systemic disease.

Design outcomes

Primary

MeasureTime frame
SN-MP;

Secondary

MeasureTime frame
ANB;OP-SN;U1-PP;S-Go/N-Me;TB-TPPW;Co-Gn;Ns-Sn-Pos;

Countries

China

Contacts

Public ContactYun Lu

Shanghai Stomatological Hospital

luyun@fudan.edu.cn+86 18817878669

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026