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Three-dimensional evaluation with comparative analysis of dynamic facial soft tissue changes following van Beek Headgear-Activator and Twin-Block in growing patients with skeletal Class II malocclusion: Non-randomized clinical trial study

Three-dimensional evaluation with comparative analysis of dynamic facial soft tissue changes following van Beek Headgear-Activator and Twin-Block in growing patients with skeletal Class II malocclusion

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260427001
Enrollment
30
Registered
2026-04-27
Start date
2026-02-04
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Three-dimensional evaluation and comparative analysis of dynamic facial soft tissue changes following treatment with the van Beek Headgear-Activator and Twin-Block appliances in growing patients with skeletal Class II malocclusion, aimed at correcting mandibular underdevelopment during growth and development. Functional orthodontic appliances, dynamic facial soft tissue, van Beek Headgear-Activator, Twin-block, Class II div 1 malocclusion, Three-dimensional dynamic facial imaging system (3dMD).

Interventions

The Van Beek headgear activator design, consisted of a modified activator fitted with the extraoral arch and high pull headgear tubes incorporated into the maxillary acrylic. The intraoral activator p
Active Comparator Device,Active Comparator Device
van Beek Headgear-Activator (vBHGA) appliance,Twin-block (TB) appliance

Sponsors

Xi'an jiaotong university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1 Healthy Chinese children aged between 8 and 12 years, Prepubertal skeletal maturation CVM stages between cervical Stage 2 and cervical Stage 3 2 Skeletal Class II division 1 malocclusion (ANB more than 4) and retrognathic mandible (SNB smaller than 78) with convex profile 3 an overjet greater than 5 mm 4 normal or protruded maxilla 5 an improvement in facial profile when the lower jaw was postured in a forward position 6 No previous history of orthodontic therapy 7 No history or clinically diagnosed TMJ disorders

Exclusion criteria

Exclusion criteria: 1 history of craniofacial anomalies and temporomandibular joint diseases. 2 post-pubertal growth period. 3 history of orthognathic treatment, orthodontic treatment, or surgery of the temporomandibular joint. 4 psychosocial impairment. 5 presence of severe systemic diseases or tumors. 6 Congenitally missing or extracted permanent teeth.

Design outcomes

Primary

MeasureTime frame
3D landmark movements will be evaluated and compared before and after therapy in four facial expression sequences (smile lips closed, smile lips open, lip purse, and cheek puff ) For the both groups 3D landmark movements will be recorded at the beginning (T0) , after 3 month of treatment (T1), and at the end of the functional appliance therapy(T2). A sequence frame for four facial expressions will be used; the RMS values for the rest state will be defined as the initial frame, the maximum motion state frame, and the end of motion frame

Secondary

MeasureTime frame
Comparison of 3D landmark movements between the two study groups in four facial expression sequences (smile lips closed, smile lips open, lip purse, and cheek puff ) Only 2 time points (T0 and T2): before treatment (T0) and at the end of the functional appliance therapy (T2) A sequence frame for four facial expressions will be used; the RMS values for the rest frame, the maximum motion frame, and end of motion frame between the two study groups

Countries

China

Contacts

Public ContactLINA ALSHOAIBI

Xian jiaotong University

linaalshoaibi@stu.xjtu.edu.cn19567664803

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026