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Comparison of AMCOP Bioactivator and High-pull Headgear in Treating Skeletal Class II Hyperdivergent Pediatric Patients

Comparison of AMCOP Bioactivator and High-pull Headgear in Treating Skeletal Class II Hyperdivergent Pediatric Patients: a Retrospective Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06281613
Enrollment
40
Registered
2024-02-28
Start date
2024-03-03
Completion date
2024-04-30
Last updated
2024-05-23

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

Conditions

Skeletal Malocclusion

Keywords

hyperdivergency

Brief summary

The aim of the present study was to retrospectively compare the clinical use of high-pull headgear versus AMCOP bioactivators for hyperdivergent pediatric patients. Cephalometric radiographs from pediatric patients treated at the Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy and at the private practice of Dr. Cardarelli, Isernia, Italy will be collected. Cephalometric tracing from Giannì analysis will be performed at the baseline (T0) and after 18 months of treatment (T1).

Detailed description

The aim of the present study was to retrospectively compare the clinical use of high-pull headgear versus AMCOP bioactivators for hyperdivergent pediatric patients. Cephalometric radiographs from pediatric patients treated at the Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy and at the private practice of Dr. Cardarelli, Isernia, Italy will be collected. Cephalometric tracing from Giannì analysis will be performed at the baseline (T0) and after 18 months of treatment (T1).

Interventions

DEVICEAMCOP group

Patients were treated with AMCOP for 18 months.

DEVICEHigh-pull headgear

Patients were treated with high-pull headgear for 18 months.

Sponsors

University of Pavia
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
No

Inclusion criteria

* mixed or permanent dentition * skeletal class II malocclusion diagnosed with ANB angle \> 4° from cephalometric radiograph * skeletal hyperdivergency calculated from AnsPns\^GoGn angle \> 25°, and at least S-Ar\^Go \> 149° or Ar-Go\^Gn \> 137°

Exclusion criteria

* lack of compliance in the use of the orthodontic appliance * syndromic patients, cleft lip or cleft palate, severe malformations and asymmetries of the jaws.

Design outcomes

Primary

MeasureTime frameDescription
Change in cephalometric angular measurementsBaseline (T0) and after 18 months (T1)The following angular measurements will be calculated in cephalometric radiographs: SNA SNB ANB SN\^GoGn AnsPns\^GoGn Occl-MP Occl-AnsPns N-S-Ar S-Ar-Go Ar-Go-N N-Go-Gn 11-occl 11-ANSPNS 41-occl 41-GoGn Nasolabial angle Facial angle
Linear regressionsBaseline (T0) and after 18 months (T1)Linear regressions among the variables of the study and sex, age, and group of the patients will be performed.
Change in cephalometric linear measurementsBaseline (T0) and after 18 months (T1)The following linear measurements will be calculated in cephalometric radiographs: Anterior cranial base Mandibular body Mandibular ramus Posterior facial height Anterior facial height A0B0

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026