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Clinical Application and Efficacy Evaluation of a Novel High-Pull Headgear Invisible Activator

Clinical Application and Efficacy Evaluation of a Novel High-Pull Headgear Invisible Activator

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123285
Enrollment
Unknown
Registered
2026-04-23
Start date
2026-01-03
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Angle Class II high-angle malocclusion

Interventions

Experimental group:Treatment with an invisible high-pull headgear activator appliance
Control group:Treatment with a conventional headgear activator appliance

Sponsors

Hospital of Stomatology, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily cooperate with this research and sign the informed consent form. 2. The molars or incisors have an Anzenbacher type II relationship; the sagittal relationship of the maxilla and mandible is abnormal, manifested as an ANB angle > 4°; patients with high-angle type: the mandibular plane angle (MP-SN) >= 37°, FMA >= 28°, accompanied by an imbalance in the anterior-posterior height ratio. 3. No gender restrictions; age 8-12 years old, in the late stage of deciduous teeth replacement or early permanent teeth stage. 4. Overall health, without systemic diseases that affect the growth and development of the maxillofacial region. 5. Have good compliance, able to attend follow-up visits on time and complete imaging examinations.

Exclusion criteria

Exclusion criteria: 1. Those who have previously received orthodontic or jaw orthodontic treatment; 2. Those with severe facial deformities (such as cleft lip and palate, asymmetrical jawbone development, etc.); 3. Those with severe periodontal disease, dental caries or missing permanent teeth that affect the treatment outcome; 4. Those with obvious symptoms of temporomandibular joint dysfunction; 5. Pregnant or lactating women; 6. Those who participated in other clinical trials or received treatments conflicting with the intervention of this study within 6 months before the start of the research; 7. Other situations that the researcher deems unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
ANB angle;

Secondary

MeasureTime frame
Mandibular plane angle;Lower incisor inclination;Anterior-to-posterior facial height ratio;Wearing time;Completion rate;

Countries

China

Contacts

Public ContactXiong Hongzhen

Hospital of Stomatology, Southern Medical University

393208005@qq.com+86 20 8440 6334

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026