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NCT Number: NCT06281613

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

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).

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Key information

Conditions

Skeletal Malocclusion

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AMCOP group

Device

Patients were treated with AMCOP for 18 months.

High-pull headgear

Device

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

Primary outcomes

  1. Change in cephalometric angular measurements

    Time frame: Baseline (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

  2. Linear regressions

    Time frame: Baseline (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.

  3. Change in cephalometric linear measurements

    Time frame: Baseline (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

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 28, 2024
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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