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

Skeletal Malocclusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06281613
• Other study ID #: 2024-AMCOPTEO
• Status: Completed
• Start date: March 3, 2024
• Est. completion date: April 30, 2024

Study information

• Verified date: April 2024
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 30, 2024
• Est. primary completion date: April 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malocclusion
• Skeletal Malocclusion

Intervention

Device:
• AMCOP group
Patients were treated with AMCOP for 18 months.
• High-pull headgear
Patients were treated with high-pull headgear for 18 months.

Locations

Country	Name	City	State
Italy	Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia	Pavia	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)