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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06281613
Other study ID # 2024-AMCOPTEO
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 3, 2024
Est. completion date April 30, 2024

Study information

Verified date May 2024
Source University of Pavia
Contact n/a
Is FDA regulated No
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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