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

NCT06281613 | Completed

• 1 other identifier: 2024-AMCOPTEO
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Skeletal Malocclusion

Keywords

hyperdivergency

Outcome Measures

Primary Outcomes (3)

• Change in cephalometric angular measurements

  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

  Baseline (T0) and after 18 months (T1)

• Linear regressions

  Linear regressions among the variables of the study and sex, age, and group of the patients will be performed.

  Baseline (T0) and after 18 months (T1)

• Change in cephalometric linear measurements

  The following linear measurements will be calculated in cephalometric radiographs: Anterior cranial base Mandibular body Mandibular ramus Posterior facial height Anterior facial height A0B0

  Baseline (T0) and after 18 months (T1)

Study Arms (2)

Case group

Device: AMCOP group

Control Headgear

Device: High-pull headgear

Interventions

AMCOP group DEVICE

Patients were treated with AMCOP for 18 months.

Case group

High-pull headgear DEVICE

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

Control Headgear

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Orthodontic patients

You may qualify if:

• 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°

You may not qualify if:

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

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

Study Officials

• Andrea Scribante, DDS, PhD, Mac

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 28, 2024
• Study Start: March 3, 2024
• Primary Completion: April 26, 2024
• Study Completion: April 30, 2024
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)