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Upper Airways Cephalometric Measures Compared to Skeletal Class and Divergence

A

Andrea Scribante

Status

Completed

Conditions

Skeletal Malocclusion

Treatments

Diagnostic Test: Cephalometric analysis

Study type

Observational

Funder types

Other

Identifiers

NCT05725980
2023-AIRWAYSCLASS

Details and patient eligibility

About

The aim of the present study is to investigate the baseline upper airways dimensions in adult patients belonging to all skeletal classes

Full description

Lateral cephalometric radiographs of adult orthodontic patients referring for orthodontic consultation at the Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, 27100 Pavia, Italy, will be collected for the study according to the inclusion criteria.

For each lateral cephalometric radiograph, a cephalometric tracing will be performed with DeltaDent software (version 2.2.1, Outside Format, Spino d'Adda, Italy). Riedel's ANB angle [Riedel 1952] has been adopted to determine patients' skeletal class. Steiner's SN^GoGn angle [Steiner 1953] will be used to evaluate skeletal divergence. Biprotrusion will be assessed for SNA > 84° and SNB > 82°, while biretrusion for SNA < 80° and SNB < 78°.

Sample size calculation was performed with "soft palate length" as primary outcome. Considering alpha = 0.05 and power = 95%, an expected mean value of 31.05 with a standard deviation of 4.16 was hypothesized, with an expected mean difference of 3.34 [Sprenger et al. 2017], therefore 40 patients per group were required.

Statistical analysis will be conducted with R® software (version 3.1.3 R Development Core Team, R Foundation for Statistical Computing, Wein, Austria). For each cephalometric measure belonging to the three skeletal classes, descriptive statistics (mean and standard deviation) will be calculated. Appropriate statistical tests will be used to assess data normality and multiple comparisons. Linear regressions will be performed between upper airways diameters and SNA, SNB, ANB, SN^GoGn, ANSPNS^GoGn, PT, PL, sex and age.

Enrollment

120 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients with permanent dentition
  • Caucasian patients
  • Patients with one lateral cephalometric digital radiograph executed in Natural Head Position (patients were asked to keep the teeth in contact and the lips relaxed).

Exclusion criteria

  • maxillo-facial traumas
  • nasopharyngeal pathologies
  • craniofacial dysmorphisms
  • orthognatic surgery
  • radiographs not performed in Natural Head Position
  • unsuitable radiographs

Trial design

120 participants in 3 patient groups

Skeletal Class I patients
Description:
Patients from this group present 0° \< ANB \< 4° on the cephalometric tracing.
Treatment:
Diagnostic Test: Cephalometric analysis
Skeletal Class II patients
Description:
Patients from this group present ANB \> 4° on the cephalometric tracing.
Treatment:
Diagnostic Test: Cephalometric analysis
Skeletal Class III patients
Description:
Patients from this group present ANB \< 0° on the cephalometric tracing.
Treatment:
Diagnostic Test: Cephalometric analysis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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