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

Completed

• Conditions: Skeletal Malocclusion
• Interventions: Device: High-pull headgear; Device: AMCOP group

• Registration Number: NCT06281613
• Lead Sponsor: University of Pavia

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).

Study Timeline

• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-02-26
• Study First Posted: 2024-02-28
• Study Start: 2024-03-03
• Primary Completion: 2024-04-26
• Study Completion: 2024-04-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Headgear	High-pull headgear	-
Case group	AMCOP group	-

Primary Outcome Measures

Name	Time	Method
Change in cephalometric angular measurements	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
Linear regressions	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.
Change in cephalometric linear measurements	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

Trial Locations

Locations (1)

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia; 🇮🇹 Pavia, Lombardy, Italy