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

NCT ID: NCT06281613

Last Updated: 2024-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-03

Study Completion Date

2024-04-30

Brief Summary

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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

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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).

Conditions

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Skeletal Malocclusion

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Case group

AMCOP group

Intervention Type DEVICE

Patients were treated with AMCOP for 18 months.

Control Headgear

High-pull headgear

Intervention Type DEVICE

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

Interventions

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AMCOP group

Patients were treated with AMCOP for 18 months.

Intervention Type DEVICE

High-pull headgear

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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Andrea Scribante

Associate Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Scribante, DDS, PhD, Mac

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

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

Pavia, Lombardy, Italy

Site Status

Countries

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Italy

Other Identifiers

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2024-AMCOPTEO

Identifier Type: -

Identifier Source: org_study_id

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